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In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

The effects of scapular mobilization in patients with subacromial impingement syndrome: a randomized, double-blind, placebo-controlled clinical trial.

OBJECTIVE To determine the effects of scapular mobilization on function , pain , range of motion , and satisfaction in patients with subacromial impingement syndrome ( SAIS ) . DESIGN R and omized , double-blind , placebo-controlled clinical trial . SETTING University hospital clinics in Turkey . PARTICIPANTS 66 participants ( mean ± SD age 52.06 ± 3.71 y ) with SAIS . INTERVENTIONS Participants were r and omized into 3 groups : scapular mobilization , sham scapular mobilization , and supervised exercise . Before the interventions transcutaneous electrical stimulation and hot pack were applied to all groups . Total intervention duration for all groups was 3 wk with a total of 9 treatment sessions . MAIN OUTCOME MEASURES Shoulder function and pain intensity were primary outcome measures ; range of motion and participant satisfaction were secondary outcome measures . Shoulder function was assessed with the short form of the Disabilities of the Arm , Shoulder and H and Question naire ( DASH ) . A visual analog scale was used to evaluate pain severity . Active range of motion was measured with a universal goniometer . A 7-point Likert scale was used to evaluate satisfaction . Outcome measurements were performed at baseline , before visits 5 and 10 , 4 wk after visit 9 , and 8 wk after visit 9 . RESULTS There was no group difference for DASH score ( P = .75 ) , pain at rest ( P = .41 ) , pain with activity ( P = .45 ) , pain at night ( P = .74 ) , and shoulder flexion ( P = .65 ) , external rotation ( P = .63 ) , and internal rotation ( P = .19 ) . There was a significant increase in shoulder motion and function and a significant decrease in pain across time when all groups were combined ( P < .001 ) . The level of satisfaction was not significantly different for any of the questions about participant satisfaction between all groups ( P > .05 ) . CONCLUSION There was not a significant advantage of scapular mobilization for shoulder function , pain , range of motion , and satisfaction compared with sham or supervised-exercise groups in patients with SAIS

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

Effects of Stretching and Strengthening Exercises, With and Without Manual Therapy, on Scapular Kinematics, Function, and Pain in Individuals With Shoulder Impingement: A Randomized Controlled Trial.

STUDY DESIGN R and omized controlled trial . OBJECTIVE To evaluate the effects of an exercise protocol , with and without manual therapy , on scapular kinematics , function , pain , and mechanical sensitivity in individuals with shoulder impingement syndrome . BACKGROUND Stretching and strengthening exercises have been shown to effectively decrease pain and disability in individuals with shoulder impingement syndrome . There is still conflicting evidence regarding the efficacy of adding manual therapy to an exercise therapy regimen . METHODS Forty-six patients were assigned to 1 of 2 groups , one of which received a 4-week intervention of stretching and strengthening exercises ( exercise alone ) and the other the same intervention , supplemented by manual therapy targeting the shoulder and cervical spine ( exercise plus manual therapy ) . All outcomes were measured preintervention and postintervention at 4 weeks . Outcome measures were scapular kinematics in the scapular and sagittal planes during arm elevation , function as determined through the Disabilities of the Arm , Shoulder and H and ( DASH ) question naire , pain as assessed with a visual analog scale , and mechanical sensitivity as assessed with pressure pain threshold . RESULTS Independent of the intervention group , small , clinical ly irrelevant changes in scapular kinematics were observed postintervention . A significant group-by-time interaction effect ( P = .001 ) was found for scapular anterior tilt during elevation in the sagittal plane , with a 3.0 ° increase ( 95 % confidence interval [ CI ] : -1.5 ° , 7.5 ° ) relative to baseline in the exercise-plus-manual therapy group compared to a decrease of 0.3 ° ( 95 % CI : -4.2 ° , 4.8 ° ) in the exercise-alone group . Pain , mechanical sensitivity , and the DASH score improved similarly for both groups by the end of the intervention period . CONCLUSION Adding manual therapy to an exercise protocol did not enhance improvements in scapular kinematics , function , and pain in individuals with shoulder impingement syndrome . The noted improvements in pain and function are not likely explained by changes in scapular kinematics

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

[Extracorporeal shockwave therapy (ESWT) as therapeutic option in supraspinatus tendon syndrome? One year results of a placebo controlled study].

Extracorporeal shock wave therapy ( ESWT ) is seen as a therapeutic option in the treatment of chronic supraspinatus tendinitis by some authors . To test whether ESWT comprising 3 x 2000 pulses with the positive energy flux density ED+ of 0.33 mJ/mm2 is clinical ly superior to a sham ESWT treatment , a prospect i ve , r and omized , single-blinded , placebo-controlled study with an independent observer was performed . Forty patients were treated either by verum ESWT or sham ESWT under local anesthesia . Target criteria were the age-corrected Constant score , pain at rest and during activity on a visual analogue scale , and subjective improvement . Patients who reported no subjective improvement after 12 weeks were deblinded and received verum ESWT if they had belonged to the placebo group ( partial crossover ) . The results of the verum group lie within the range of results for ESWT published by other authors . Patients in the placebo group with local anesthetic showed equally good results . At 12 weeks , and 1 year after intervention , no difference could be found between the verum and placebo groups regarding Constant score , pain , shoulder function , or subjective improvement . The nonresponders to the placebo ESWT continued to show no improvement after receiving verum ESWT . This contradicts a specific ESWT effect . Based on the results of this placebo-controlled study , ESWT appears to have no clinical ly relevant effect on supraspinatus tendinitis . The study underlines the importance of a control group in evaluating new treatment methods for diseases with unknown natural history

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

Injection of the subacromial bursa in patients with rotator cuff syndrome: a prospective, randomized study comparing the effectiveness of different routes.

BACKGROUND Rotator cuff syndrome is often treated with subacromial injection of corticosteroid and local anesthetic . It has not been established if the common injection routes of the bursa are equally accurate . METHODS We conducted a prospect i ve clinical trial involving seventy-five shoulders in seventy-five patients who were r and omly assigned to receive a subacromial injection through an anterior , lateral , or posterior route with respect to the acromion . An experienced physician performed the injections , which contained radiopaque contrast medium , corticosteroid , and local anesthetic . After the injection , a musculoskeletal radiologist , blinded to the injection route , interpreted all of the radiographs . RESULTS The rate of accuracy varied with the route of injection , with a rate of 56 % for the posterior route , 84 % for the anterior route , and 92 % for the lateral route ( p = 0.006 ; chi-square test ) . The accuracy of injection through the posterior route was significantly lower than that through either the anterior or the lateral route ( p < 0.05 for both comparisons ; Poisson regression ) . In addition , the accuracy of injection was significantly lower in females than in males ( p < 0.006 ; chi-square test ) . Among males , no differences between the routes were noted ( with accuracy rates of 89 % for the posterior route , 92 % for the anterior route , and 93 % for the lateral route ) . Among females , however , the accuracy of injection was lower for the posterior route than for either the anterior or the lateral route ( with accuracy rates of 38 % for the posterior route , 77 % for the anterior route , and 91 % for the lateral route ) ( p < 0.05 ) . CONCLUSIONS The anterior and lateral routes of subacromial bursal injection were more accurate than the posterior route . The accuracy of subacromial bursal injection was significantly different between males and females , mainly because of a lower accuracy of bursal injection with use of the posterior route in females . The present study suggests that the posterior route is the least accurate method for injection of the subacromial bursa in females

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

Naturopathic treatment of rotator cuff tendinitis among Canadian postal workers: a randomized controlled trial.

OBJECTIVE To explore the effectiveness of naturopathic care ( NC ) on rotator cuff tendinitis using a prospect i ve r and omized clinical trial design . METHODS Canadian postal workers with rotator cuff tendinitis for a duration of > 6 weeks were r and omized to receive NC ( n = 43 ) or st and ardized physical exercises ( PEs ; n = 42 ) over 12 weeks . Participants in the NC group received dietary counseling , acupuncture , and Phlogenzym ( 2 tablets 3 times/day ) . The PE intervention group received passive , active-assisted , and active range of motion exercises and matched placebo . The primary outcome measure was the Shoulder Pain and Disability Index ( SPADI ) , and secondary outcomes were the pain visual analog scale ( VAS ) , Short Form 36 ( SF-36 ) , Measure Yourself Medical Outcomes Profile ( MYMOP ) , and shoulder maximal range of motion . Participants and assessors were blinded to group and placebo allocation . RESULTS Seventy-seven participants ( 87 % ) completed > or=8 weeks of the trial . Final total SPADI scores decreased by 54.5 % ( P < 0.0001 ) in the NC group and by 18 % ( P = 0.0241 ) in the PE group . Between-group differences in changes to SPADI scores showed statistically significant decreases in shoulder pain and disability in the NC group compared with the PE group ( P < 0.0001 ) . Significant differences between groups were also observed in the pain VAS , MYMOP , SF-36 , and shoulder extension , flexion , and abduction , with the NC group showing superiority in each outcome . No serious adverse reactions were observed . CONCLUSION NC and PE provided significant improvements , with greater improvement in shoulder function in the NC group compared with the PE group . Statistically significant improvements in quality of life measures were observed in the NC group as compared with the PE group

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

A controlled trial of the benefits of ultrasound-guided steroid injection for shoulder pain.

OBJECTIVES We studied the value of ultrasound ( US ) to define shoulder pathology and guide local steroid injection in comparison with a st and ard injection in the management of the acute painful shoulder . METHODS Seventy consecutive patients with acute shoulder pain were assessed clinical ly and by US . Patients were r and omized to receive either a st and ard subacromial infiltration of 7 mg of betamethasone or a US-guided injection according to the US diagnosis . Follow-up evaluations were performed by an independent assessor who was blinded to the results of the initial US and clinical assessment s. RESULTS Sixty-seven patients completed the study . Both groups showed a significant reduction in both daytime and night pain compared to baseline . The US injection group had significantly less pain at rest at 2 and 6 weeks ( NRS : 1.6 vs 3.3 , P<0.005 ; 3 vs 4.2 , P<0.04 ) . The percentage of good responders was significantly higher in US group at 2 weeks , ( 81 % vs 54 % , P<0.005 ) and 6 weeks ( 64 % vs 38 % , P<0.05 ) . At 2 and 6 weeks , responder rate and activity pain scores as well as Constant score were in favour of US , though did not reach statistical significance . CONCLUSION Local steroid injection for shoulder pain leads to significant improvements in pain and function for up to 12 weeks . An US examination to define the origin of shoulder pain as well as to guide injection provides significant additional benefits for up to 6 weeks . We recommend routine US examination as part of the management of acute shoulder pain

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

Interferential light therapy in the treatment of shoulder tendinopathies: a randomized controlled pilot study

Objectives : To test the safety of the diode light therapy and evaluate the advantages of the interferential effect of two light probes versus a conventional light probe in the relief of shoulder pain and disability caused by shoulder tendinopathies . Design : R and omized single-blind pilot study . Setting : Clinical electrotherapy unit . Participants : A total of 30 patients with shoulder pain from tendinopathies . Interventions : The patients were r and omly assigned into two groups . Group 1 ( n = 15 ) received interferential light therapy generated by two independent and identical cluster probes composed of light emitting and superluminescent diodes . Similarly , two applicators were applied in group 2 ( n = 15 ) , but only one was active , as in conventional clinical therapy . Each multi-diode cluster probe was composed of seven light-emitting diodes at 600 nm and 12 superluminescent diodes at 950 nm . Main outcome measures : Pain was evaluated by visual analogue scale ( VAS ) at day , at night and during several shoulder movements . Shoulder functional status was measured by means of the University California Los Angeles scale ( UCLA ) . Results : Comparison between both treatments using the Mann – Whitney U-test showed better results for the interferential treatment . There were significant differences in pain reduction during abduction ( P < 0.05 ) and external rotation ( P < 0.05 ) , with pain reductions in abduction and external rotation of 1.5 ( ± 1.3 ) and 0.5 ( ± 1.0 ) respectively . Conclusion : Interferential light therapy was safe and effective regarding the shoulder pain reduction during abduction and external rotation movements . The estimated size sample needed for future two-treatment parallel- design studies will require about 60 patients

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

Comparative effectiveness of ultrasonophoresis and iontophoresis in impingement syndrome: a double-blind, randomized, placebo controlled trial

Objective : To estimate the effectiveness of ultrasonophoresis and iontophoresis with sodium diclofenac used in addition to an exercise program for patients with impingement syndrome . Design : Multicentre , double-blind , placebo r and omized controlled trial . Setting : “ Mancha Centro ” Outpatient primary care clinic ( Spain ) . Participants : A total of 175 patients were considered , of whom 88 met criteria and agreed . Intervention : The patients were r and omly assigned to one of three groups : a ) st and ard treatment ( supervised exercises and cryotherapy ) along with placebo iontophoresis and placebo ultrasonophoresis ; b ) st and ard treatment , iontophoresis , and placebo ultrasonophoresis ; and c ) st and ard treatment , ultrasonophoresis , and placebo iontophoresis . All patients received 15 treatment sessions . Outcome measures : Baseline , 6- , and 12-week evaluations were carried out . Functionality , pain , range of motion , strength and quality of life were assessed with the Disabilities of the Arm , Shoulder and H and Question naire ( DASH ) , Constant-Murley score , and SF-36 scale . Results : Ultrasonophoresis group experienced significant decreases in pain compared to the st and ard treatment group ( 12.7 and 13.5 points in “ bodily pain ” dimension of SF-36 ; and 1,5 and 2,2 points in “ pain ” dimension of Constant Murley after 6 and 12 weeks of therapy , respectively ) . They also reported improved range of motion compared to the exercises group ( 2,1 points in Constant-Murley after 6 weeks and 12 weeks ) , better vitality and overall health ( SF-36 dimensions ) . Iontophoresis , however , led to no significant improvements when added to the st and ard treatment . Conclusion : In patients with impingement syndrome , a combination of ultrasonophoresis and an exercise program are better than a combination of iontophoresis and the same exercise program or the exercise program alone

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

Motor control retraining exercises for shoulder impingement: effects on function, muscle activation, and biomechanics in young adults.

OBJECTIVE Evidence for effective management of shoulder impingement is limited . The present study aim ed to quantify the clinical , neurophysiological , and biomechanical effects of a scapular motor control retraining for young individuals with shoulder impingement signs . METHOD Sixteen adults with shoulder impingement signs ( mean age 22 ± 1.6 years ) underwent the intervention and 16 healthy participants ( 24.8 ± 3.1years ) provided reference data . Shoulder function and pain were assessed using the Shoulder Pain and Disability Index ( SPADI ) and other question naires . Electromyography ( EMG ) and 3-dimensional motion analysis was used to record muscle activation and kinematic data during arm elevation to 90 ° and lowering in 3 planes . Patients were assessed pre and post a 10-week motor control based intervention , utilizing scapular orientation retraining . RESULTS Pre-intervention , patients reported pain and reduced function compared to the healthy participants ( SPADI in patients 20 ± 9.2 ; healthy 0 ± 0 ) . Post-intervention , the SPADI scores reduced significantly ( P < .001 ) by a mean of 10 points ( ±4 ) . EMG showed delayed onset and early termination of serratus anterior and lower trapezius muscle activity pre-intervention , which improved significantly post-intervention ( P < .05 ) . Pre-intervention , patients exhibited on average 4.6 - 7.4 ° less posterior tilt , which was significantly lower in 2 arm elevation planes ( P < .05 ) than healthy participants . Post-intervention , upward rotation and posterior tilt increased significantly ( P < .05 ) during 2 arm movements , approaching the healthy values . CONCLUSION A 10-week motor control intervention for shoulder impingement increased function and reduced pain . Recovery mechanisms were indicated by changes in muscle recruitment and scapular kinematics . The efficacy of the intervention requires further examined in a r and omized control trial

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

Randomised Controlled Trial of Contralateral Manual Acupuncture for the Relief of Chronic Shoulder Pain

Objective To explore the effects of contralateral manual acupuncture ( MA ) on patients with chronic shoulder pain . Methods Eighty patients with chronic shoulder pain were r and omly allocated to receive contralateral MA ( n=38 ) for 4 weeks or to remain on a waiting list while receiving conventional orthopaedic therapy ( n=42 ) . Visual analogue scale ( VAS ) scores were taken as the primary outcome measure and used for a priori power calculation . Secondary outcome measures for the assessment of shoulder mobility and quality of life included the Jobe test , the Constant-Murley ( CM ) score , the Disabilities of the Arm , Shoulder and H and ( DASH ) score , and the 36 item Short Form Health Survey ( SF-36 ) . Results Intention-to-treat ( ITT ) analysis demonstrated significant pain relief with contralateral acupuncture , with mean differences in VAS scores compared to the waiting list group of −19.4 ( −28.0 to −10.8 ) at 2 weeks , −40.4 ( −49.0 to −31.8 ) at 4 weeks , −41.1 ( −49.7 to −32.5 ) at 8 weeks , and −40.9 ( −49.5 to −32.3 ) at 16 weeks . CM and DASH scores were also improved at all time points ( p<0.01 ) . Shoulder mobility , physical functioning , social functioning and mental health components of the SF-36 were also improved by contralateral acupuncture at 8 weeks . No significant adverse effects were observed . Conclusions These results demonstrate beneficial effects of contralateral acupuncture in the treatment of chronic shoulder pain , both in terms of pain and function . Future research is required to compare directly the effects of local and contralateral acupuncture and to quantify the specific and non-specific effects . Trial Registration Number NCT01733914

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

Does adding heavy load eccentric training to rehabilitation of patients with unilateral subacromial impingement result in better outcome? A randomized, clinical trial

Purpose To investigate superior value of adding heavy load eccentric training to conservative treatment in patients with subacromial impingement . Methods Sixty-one patients with subacromial impingement were included and r and omly allocated to the traditional rotator cuff training ( TT ) group ( n = 30 , mean age = 39.4 ± 13.1 years ) or traditional rotator training combined with heavy load eccentric training ( TT + ET ) group ( n = 31 , mean age = 40.2 ± 12.9 years ) . Isometric strength was measured to abduction at 0 ° , 45 ° and 90 ° of scapular abduction and to internal and external rotation . The SPADI question naire was used to measure shoulder pain and function . Patients rated subjective perception of improvement . Outcome was assessed at baseline , at 6 and 12 weeks after start of the intervention . Both groups received 9 physiotherapy treatments over 12 weeks . At home , the TT group performed traditional rotator cuff strengthening exercises 1x/day . The TT + ET group performed the same exercises 1x/day and a heavy load eccentric exercise 2x/day . Results After treatment , isometric strength had significantly increased in all directions , and SPADI score had significantly decreased . The TT + ET group showed a 15 % higher gain in abduction strength at 90 ° of scapular abduction . Chi-square tests showed patients ’ self-rated perception of improvement was similar in both groups . Conclusion Adding heavy load eccentric training result ed in a higher gain in isometric strength at 90 ° of scapular abduction , but was not superior for decreasing pain and improving shoulder function . This study showed that the combination of a limited amount of physiotherapy sessions combined with a daily home exercise programme is highly effective in patients with impingement . Level of evidence II

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

Supervised Exercises Compared With Radial Extracorporeal Shock-Wave Therapy for Subacromial Shoulder Pain: 1-Year Results of a Single-Blind Randomized Controlled Trial

Background Evidence from a recent r and omized controlled trial indicated that supervised exercises ( SE ) were more effective than radial extracorporeal shock-wave therapy ( rESWT ) for the treatment of subacromial shoulder pain in the short to medium term . Little knowledge exists about the long-term results of rESWT for subacromial pain . Objective The aim of this study was to evaluate the results of rESWT and SE provided to patients with subacromial shoulder pain after 1 year . Design This was a single-blind r and omized controlled trial . Setting The study was conducted in the outpatient clinic of the Physical Medicine and Rehabilitation Department at Oslo University Hospital , Ullevaal , Norway . Patients One hundred four patients with subacromial shoulder pain lasting at least 3 months participated . Patients were r and omly assigned to either an rESWT group ( n=52 ) or an SE group ( n=52 ) . Intervention The rESWT intervention consisted of one session weekly for 4 to 6 weeks . The SE intervention consisted of two 45-minute sessions per week for up to 12 weeks . Measurements The primary outcome measure was the Shoulder Pain and Disability Index . Secondary outcome measures were questions regarding pain and function and work status . Results After 1 year , an intention-to-treat analysis showed no significant differences between the 2 groups for the primary outcome measure ( −7.6 points , 95 % confidence interval=−16.6 to 0.5 ) and pain , function , and medication use . Twenty-nine participants ( 60 % ) in the SE group versus 24 participants ( 52 % ) in the rESWT group were categorized as clinical ly improved . Thirty-eight participants in the SE group were at work compared with 30 participants in the rESWT group ( odds ratio=1.1 , 95 % confidence interval=1.0 to 1.2 ) . Fewer patients in the SE group had received additional treatments between 18 weeks and 1 year . Limitations The lack of a placebo control group , the lack of a cost-benefit analysis , and the small sample size were limitations of the study . Conclusion No significant difference was found between the SE and rESWT groups at the 1-year follow-up . More participants in the SE group had returned to work

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

Does Passive Mobilization of Shoulder Region Joints Provide Additional Benefit Over Advice and Exercise Alone for People Who Have Shoulder Pain and Minimal Movement Restriction? A Randomized Controlled Trial

Background Passive mobilization of shoulder region joints , often in conjunction with other treatment modalities , is used for the treatment of people with shoulder pain and minimal movement restriction . However , there is only limited evidence supporting the efficacy of this treatment modality . Objective The purpose of this study was to determine whether passive mobilization of shoulder region joints adds treatment benefit over exercise and advice alone for people with shoulder pain and minimal movement restriction . Design This was a r and omized controlled clinical trial with short- , medium- and longer-term follow-up . Setting The study was conducted in a metropolitan teaching hospital . Patients Ninety-eight patients with shoulder pain of local mechanical origin and minimal shoulder movement restriction were r and omly allocated to either a control group ( n=51 ) or an experimental group ( n=47 ) . Intervention Participants in both groups received advice and exercises design ed to restore neuromuscular control at the shoulder . In addition , participants in the experimental group received passive mobilization specifically applied to shoulder region joints . Measurements Outcome measurements of shoulder pain and functional impairment , self-rated change in symptoms , and painful shoulder range of motion were obtained at 1 , 3 , and 6 months after entry into the trial . All data were analyzed using the intention-to-treat principle by repeated- measures analyses of covariance . Results No statistically significant differences were detected in any of the outcome measurements between the control and experimental groups at short- , medium- , or longer-term follow-up . Limitations Therapists and participants were not blinded to the treatment allocation . Conclusion This r and omized controlled clinical trial does not provide evidence that the addition of passive mobilization , applied to shoulder region joints , to exercise and advice is more effective than exercise and advice alone in the treatment of people with shoulder pain and minimal movement restriction

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

The therapeutic role of motor imagery on the functional rehabilitation of a stage II shoulder impingement syndrome

Abstract Purpose : Motor imagery ( MI ) has been used as a complementary therapeutic tool for motor recovery after central nervous system disease and peripheral injuries . However , it has never been used as a preventive tool . We investigated the use of MI in the rehabilitation of stage II shoulder impingement syndrome . For the first time , MI is used before surgery . Method : Sixteen participants were r and omly assigned to either a MI or control group . Shoulder functional assessment ( Constant score ) , range of motion and pain were measured before and after intervention . Results : Higher Constant score was observed in the MI than in the control group ( p = 0.04 ) . Participants in the MI group further displayed greater movement amplitude ( extension ( p < 0.001 ) ; flexion ( p = 0.025 ) ; lateral rotation ( p < 0.001 ) . Finally , the MI group showed greater pain decrease ( p = 0.01 ) . Conclusion : MI intervention seems to alleviate pain and enhance mobility , this is probably due to changes in muscle control and consequently in joint amplitude . MI might contribute to postpone or even protect from passing to stage III that may require surgery . Implication s for Rehabilitation Adding motor imagery training to classical physical therapy in a stage II impingement syndrome : Helps in alleviating pain Enhances shoulder mobility Motor imagery is a valuable technique that can be used as a preventive tool before the stage III of the impingement syndrome

In many instances , no or minimal attempts to screen were undertaken or reported .

Background Subacromial shoulder pain is a common clinical presentation with much diagnostic uncertainty . Some of this uncertainty relates to the involvement of the cervical spine as a source or contribution to subacromial shoulder pain . Currently , there is no accepted method of screening of the cervical spine in the presence of subacromial shoulder pain , which risks patients receiving misguided and /or ineffective interventions . Objective To evaluate approaches used to screen the cervical spine in patients with subacromial shoulder pain .

Although it is still early to draw a conclusion , available studies are showing promise for use of mobile device apps for treatment of individuals with ASD .

OBJECTIVE The current study was performed to assess the evidence for effects of therapeutic intervention with mobile device applications ( apps ) for individuals with autism spectrum disorder ( ASD ) .

CONSORT-EHEALTH: Improving and Standardizing Evaluation Reports of Web-based and Mobile Health Interventions

Background Web-based and mobile health interventions ( also called “ Internet interventions ” or " eHealth/mHealth interventions ") are tools or treatments , typically behaviorally based , that are operationalized and transformed for delivery via the Internet or mobile platforms . These include electronic tools for patients , informal caregivers , healthy consumers , and health care providers . The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement was developed to improve the suboptimal reporting of r and omized controlled trials ( RCTs ) . While the CONSORT statement can be applied to provide broad guidance on how eHealth and mHealth trials should be reported , RCTs of web-based interventions pose very specific issues and challenges , in particular related to reporting sufficient details of the intervention to allow replication and theory-building . Objective To develop a checklist , dubbed CONSORT-EHEALTH ( Consoli date d St and ards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth ) , as an extension of the CONSORT statement that provides guidance for authors of eHealth and mHealth interventions . Methods A literature review was conducted , followed by a survey among eHealth experts and a workshop . Results A checklist instrument was constructed as an extension of the CONSORT statement . The instrument has been adopted by the Journal of Medical Internet Research ( JMIR ) and authors of eHealth RCTs are required to su bmi t an electronic checklist explaining how they addressed each subitem . Conclusions CONSORT-EHEALTH has the potential to improve reporting and provides a basis for evaluating the validity and applicability of eHealth trials . Subitems describing how the intervention should be reported can also be used for non- RCT evaluation reports . As part of the development process , an evaluation component is essential ; therefore , feedback from authors will be solicited , and a before-after study will evaluate whether reporting has been improved

Although it is still early to draw a conclusion , available studies are showing promise for use of mobile device apps for treatment of individuals with ASD .

OBJECTIVE The current study was performed to assess the evidence for effects of therapeutic intervention with mobile device applications ( apps ) for individuals with autism spectrum disorder ( ASD ) .

Although it is still early to draw a conclusion , available studies are showing promise for use of mobile device apps for treatment of individuals with ASD .

OBJECTIVE The current study was performed to assess the evidence for effects of therapeutic intervention with mobile device applications ( apps ) for individuals with autism spectrum disorder ( ASD ) .

A randomised controlled trial of an iPad‐based application to complement early behavioural intervention in Autism Spectrum Disorder

BACKGROUND Technology-based interventions for Autism Spectrum Disorder ( ASD ) have proliferated , but few have been evaluated within the context of a r and omised controlled trial ( RCT ) . This RCT evaluated the efficacy of one technology-based early intervention programme ( Therapy Outcomes By You ; TOBY ) in young children with ASD . METHODS TOBY is an app-based learning curriculum design ed for children and parents as a complement to early behavioural intervention . Eighty children ( 16 female ) were recruited to this RCT within 12 months of receiving a diagnosis of ASD ( M age = 3.38 ; SD = 0.69 ) and r and omised to receive either treatment-as-usual ( community-based intervention , n = 39 ) or the TOBY therapy ( at least 20 min/day ) plus treatment-as-usual ( n = 41 ) for a period of 6 months . Outcomes were assessed at 3 and 6 months postbaseline . ( Australian New Zeal and Clinical Trials Registry : ACTRN12614000738628 ; www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?id=365463 ) . RESULTS Children in the TOBY intervention group averaged 19 min/day engaging with the app in the first 3 months , but only 2 min/day during the second 3 months . There was no group difference in scores on the primary outcome , the Autism Treatment Evaluation Checklist , at either the 3- or 6-month follow-up . However , significant improvements at the 6-month follow-up were observed in the TOBY intervention group relative to the treatment-as-usual group on three secondary outcomes : the Fine Motor and Visual Reception subscales of the Mullen Scale of Early Learning and the Total Words Understood scale of the MacArthur-Bates Communicative Development Index . Statistical trends towards improvement in the TOBY intervention group were observed on measures of adaptive function , although these decreased in magnitude from the 3- to 6-month follow-up . CONCLUSIONS This study provides evidence that technology-based interventions may provide a relatively low-cost addition to existing therapist-delivered interventions for children with ASD . However , sustained use of the app over the full 6-month period was a challenge for most families

Although it is still early to draw a conclusion , available studies are showing promise for use of mobile device apps for treatment of individuals with ASD .

OBJECTIVE The current study was performed to assess the evidence for effects of therapeutic intervention with mobile device applications ( apps ) for individuals with autism spectrum disorder ( ASD ) .

Although it is still early to draw a conclusion , available studies are showing promise for use of mobile device apps for treatment of individuals with ASD .

OBJECTIVE The current study was performed to assess the evidence for effects of therapeutic intervention with mobile device applications ( apps ) for individuals with autism spectrum disorder ( ASD ) .

A trial of an iPad™ intervention targeting social communication skills in children with autism

This study evaluated a technology-based early intervention for social communication skills in pre-schoolers in a r and omised controlled trial . Participants were 54 children aged under 6 years with a diagnosis of autism , assigned to either intervention or control conditions . The app engaged children , who played consistently , regardless of developmental level , and was rated highly by parents . There were no significant group differences in parent-report measures post-intervention , nor in a measure of parent – child play at follow-up . Therefore , this intervention did not have an observable impact on real-world social communication skills and caution is recommended about the potential usefulness of iPad ™ apps for amelioration of difficulties in interaction . However , positive attitudes among participants , lack of harms and the potential of apps to deliver therapeutic content at low economic cost suggest this approach is worth pursuing further , perhaps targeting other skill domains

Although it is still early to draw a conclusion , available studies are showing promise for use of mobile device apps for treatment of individuals with ASD .

OBJECTIVE The current study was performed to assess the evidence for effects of therapeutic intervention with mobile device applications ( apps ) for individuals with autism spectrum disorder ( ASD ) .

Although it is still early to draw a conclusion , available studies are showing promise for use of mobile device apps for treatment of individuals with ASD .

OBJECTIVE The current study was performed to assess the evidence for effects of therapeutic intervention with mobile device applications ( apps ) for individuals with autism spectrum disorder ( ASD ) .

Feature-level analysis of a novel smartphone application for smoking cessation

Abstract Background : Currently , there are over 400 smoking cessation smartphone apps available , downloaded an estimated 780,000 times per month . No prior studies have examined how individuals engage with specific features of cessation apps and whether use of these features is associated with quitting . Objectives : Using data from a pilot trial of a novel smoking cessation app , we examined : ( i ) the 10 most-used app features , and ( ii ) prospect i ve associations between feature usage and quitting . Methods : Participants ( n = 76 ) were from the experimental arm of a r and omized , controlled pilot trial of an app for smoking cessation called “ SmartQuit , ” which includes elements of both Acceptance and Commitment Therapy ( ACT ) and traditional cognitive behavioral therapy ( CBT ) . Utilization data were automatically tracked during the 8-week treatment phase . Thirty-day point prevalence smoking abstinence was assessed at 60-day follow-up . Results : The most-used features – quit plan , tracking , progress , and sharing – were mostly CBT . Only two of the 10 most-used features were prospect ively associated with quitting : viewing the quit plan ( p = 0.03 ) and tracking practice of letting urges pass ( p = 0.03 ) . Tracking ACT skill practice was used by fewer participants ( n = 43 ) but was associated with cessation ( p = 0.01 ) . Conclusions : In this exploratory analysis without control for multiple comparisons , viewing a quit plan ( CBT ) as well as tracking practice of letting urges pass ( ACT ) were both appealing to app users and associated with successful quitting . Aside from these features , there was little overlap between a feature ’s popularity and its prospect i ve association with quitting . Tests of causal associations between feature usage and smoking cessation are now needed

Although it is still early to draw a conclusion , available studies are showing promise for use of mobile device apps for treatment of individuals with ASD .

OBJECTIVE The current study was performed to assess the evidence for effects of therapeutic intervention with mobile device applications ( apps ) for individuals with autism spectrum disorder ( ASD ) .

Although it is still early to draw a conclusion , available studies are showing promise for use of mobile device apps for treatment of individuals with ASD .

OBJECTIVE The current study was performed to assess the evidence for effects of therapeutic intervention with mobile device applications ( apps ) for individuals with autism spectrum disorder ( ASD ) .

Incorporating a Peer-Mediated Approach Into Speech-Generating Device Intervention: Effects on Communication of Preschoolers With Autism Spectrum Disorder.

Purpose This study examined the effects of incorporating a peer-mediated approach into a speech-generating device ( SGD ) intervention on communication of 45 nonverbal and minimally verbal preschoolers with autism spectrum disorder ( ASD ) and 95 peers without disabilities . The SGD was an iPad 2 ( Apple ) with voice output app . Method Effects were evaluated using a multivariate r and omized control trial design with repeated measures for 4 cohorts across baseline , intervention , generalization , and maintenance phases . Children were r and omly assigned to an experimental treatment that trained peers on use of the SGD or a business-as-usual comparison condition with untrained peers . Communication outcomes were measured for both children with ASD and peers . Results Children receiving the treatment demonstrated significant increases in rates of communication and more balanced responses and initiations ( a measure of reciprocity ) than children in the comparison group . They were able to generalize improvements and maintain communication gains . Treatment fidelity was high for school staff and peer implementation . Conclusions Results support positive effects on communication of teaching young children with ASD and peers without disabilities to use the same SGD system in typical preschool activities . SGD interventions that utilize peer-mediated approaches may improve core deficits in communication and reciprocity and allow for greater classroom social participation and interactions with peers

Although it is still early to draw a conclusion , available studies are showing promise for use of mobile device apps for treatment of individuals with ASD .

OBJECTIVE The current study was performed to assess the evidence for effects of therapeutic intervention with mobile device applications ( apps ) for individuals with autism spectrum disorder ( ASD ) .

Although it is still early to draw a conclusion , available studies are showing promise for use of mobile device apps for treatment of individuals with ASD .

OBJECTIVE The current study was performed to assess the evidence for effects of therapeutic intervention with mobile device applications ( apps ) for individuals with autism spectrum disorder ( ASD ) .

A Randomised Controlled Trial of an Information Communication Technology Delivered Intervention for Children with Autism Spectrum Disorder Living in Regional Australia

This exploratory r and omised controlled trial tested the effectiveness of a tablet-based information communication technology early intervention application to augment existing therapy with the aim of improving visual motor , imitation , language and social skills in young children with ASD who reside in regional areas . Fifty-nine participants were recruited and r and omised to either a therapy-as-usual group or intervention group . With the exception of the expressive language subscale on the Mullen Scales of Early Learning , no significant between-group differences were recorded for visual motor , imitation , receptive language and social skills of participants between baseline and post-intervention . When all participants were pooled and measured over time , improvements were shown in receptive and pragmatic language and social skills ; these gains were maintained , thus suggesting skill acquisition

Although it is still early to draw a conclusion , available studies are showing promise for use of mobile device apps for treatment of individuals with ASD .

OBJECTIVE The current study was performed to assess the evidence for effects of therapeutic intervention with mobile device applications ( apps ) for individuals with autism spectrum disorder ( ASD ) .

Although it is still early to draw a conclusion , available studies are showing promise for use of mobile device apps for treatment of individuals with ASD .

OBJECTIVE The current study was performed to assess the evidence for effects of therapeutic intervention with mobile device applications ( apps ) for individuals with autism spectrum disorder ( ASD ) .

A pilot community‐based randomized comparison of speech generating devices and the picture exchange communication system for children diagnosed with autism spectrum disorder

A pilot community‐based r and omized controlled trial was conducted to compare the effects of the Picture Exchange Communication System ( PECS ) to a teaching sequence using a high‐tech Speech Generating Device ( SGD ) to teach social communication behaviors . The two approaches were compared to evaluate the effectiveness of the newer , more high‐tech intervention using technology to improve social and communicative behavior of children diagnosed with Autism Spectrum Disorder . A total of 35 school‐age children were r and omized to either a high‐tech ( SGD device ) or low‐tech ( PECS cards ) form of Augmentative and Alternative Communication ( AAC ) . Study participants received 4 months of communication training delivered in their classrooms , and the primary outcome measures of the trial were several functional communication skills emphasized in the PECS teaching sequence . Results indicated that both high‐tech and low‐tech AAC approaches result ed in significant improvements in communication , and that these improvements did not differ significantly between the two approaches . These findings support the use of high‐tech AAC , and highlight the need for evidence ‐based guidelines for its use as well as evaluation with individuals with a range impairments and disabilities . Autism Research 2018 , 11 : 1701–1711 . © 2018 International Society for Autism Research , Wiley Periodicals ,

Although it is still early to draw a conclusion , available studies are showing promise for use of mobile device apps for treatment of individuals with ASD .

OBJECTIVE The current study was performed to assess the evidence for effects of therapeutic intervention with mobile device applications ( apps ) for individuals with autism spectrum disorder ( ASD ) .

Although it is still early to draw a conclusion , available studies are showing promise for use of mobile device apps for treatment of individuals with ASD .

OBJECTIVE The current study was performed to assess the evidence for effects of therapeutic intervention with mobile device applications ( apps ) for individuals with autism spectrum disorder ( ASD ) .

An Evaluation of a Mobile Application Designed to Teach Receptive Language Skills to Children with Autism Spectrum Disorder

The current study evaluated the effectiveness of a mobile application , Camp Discovery , design ed to teach receptive language skills to children with autism spectrum disorder based on the principles of applied behavior analysis . Participants ( N = 28 ) were r and omly assigned to an immediate-treatment or a delayed-treatment control group . The treatment group made significant gains , p < .001 , M = 58.1 , SE = 7.54 , following 4 weeks of interaction with the application as compared to the control group , M = 8.4 , SE = 2.13 . Secondary analyses revealed significant gains in the control group after using the application and maintenance of acquired skills in the treatment group after application usage was discontinued . Findings suggest that the application effectively teaches the targeted skills

Although it is still early to draw a conclusion , available studies are showing promise for use of mobile device apps for treatment of individuals with ASD .

OBJECTIVE The current study was performed to assess the evidence for effects of therapeutic intervention with mobile device applications ( apps ) for individuals with autism spectrum disorder ( ASD ) .

Although it is still early to draw a conclusion , available studies are showing promise for use of mobile device apps for treatment of individuals with ASD .

OBJECTIVE The current study was performed to assess the evidence for effects of therapeutic intervention with mobile device applications ( apps ) for individuals with autism spectrum disorder ( ASD ) .

Effect of a social script iPad application for children with autism going to imaging.

This r and omized controlled trial feasibility study tested the effectiveness of an iPad ® application ( app ) social script intervention for children with autism spectrum disorder ( ASD ) going to imaging and their parent ( n=32 parent/child dyads ) . Parents of the children exposed to the app ( n=16 ) had lower state anxiety compared to the parents whose children were not exposed to the app ( n=16 ) ( effect size 0.33 ) . Children exposed to the app had fewer externalized challenging behaviors than the control group ( effect size 0.56 ) . The results demonstrate feasibility and efficacy of the intervention . Further study of the iPad app is warranted

Although it is still early to draw a conclusion , available studies are showing promise for use of mobile device apps for treatment of individuals with ASD .

OBJECTIVE The current study was performed to assess the evidence for effects of therapeutic intervention with mobile device applications ( apps ) for individuals with autism spectrum disorder ( ASD ) .

An acceptability analysis showed that SSRIs were generally well tolerated . Conclusions These results suggest that there is insufficient evidence to reject the null hypothesis of no differences in efficacy between SSRIs and placebo in the treatment of depression in PD .

Background Selective serotonin reuptake inhibitors ( SSRIs ) are the most commonly prescribed antidepressants for the treatment of depression in patients with Parkinson 's Disease ( PD ) but data on their efficacy are controversial .

[A comparison between low doses of amitriptyline and low doses of fluoxetin used in the control of depression in patients suffering from Parkinson's disease].

INTRODUCTION On average 40 % of all patients suffering from Parkinson s disease ( PD ) undergo bouts of depression . It is thought that this is due to a dysfunction in the orbitofrontal and dorsolateral circuits , together with hypometabolism in the orbital , cau date nucleus and frontal dorsolateral tract regions . AIMS The aim of this study is to compare the effectiveness of low doses of fluoxetin with that of low doses of amitriptyline in controlling depression in patients with PD . PATIENTS AND METHODS The study examined a total of 77 patients ( 34 females and 43 males ) , with an average age of 68.2 years , who had been suffering from PD ( according to the diagnostic criteria of Calne et al , in stage II of Hoehn and Yahr ) for an average of 6.9 years . They were divided r and omly into two groups which received fluoxetin ( 37 patients , dosage : 20 40 mg/day ) or amitriptyline ( 40 patients , dosage : between 25 and 75 mg/day ) . A basal evaluation and four others ( at 3 , 6 , 9 and 12 months of treatment ) were performed , including the STMS ( Short test of mental status ) , the Hamilton scale , and extent of functional disability using the UPDRS . A statistical analysis was performed by comparing the variance of the above mentioned parameters and the c2 test with Yates correction or the Fisher exact two tailed test , to evaluate the reasons for dropping out . In both cases a value of p < 0.05 was accepted as significant . RESULTS 58 patients finished the study . Drop out because of side effects only took place in the group that received amitriptyline ( p < 0.02 ) , which was better than fluoxetin at controlling the depression ( p < 0.009 , 0.001 , 0.002 and 0.00006 ) at 3 , 6 , 9 and 12 months , respectively . CONCLUSIONS At an average dosage of 35.2 mg/day , amitriptyline is effective in controlling the depression presented by patients with PD . However , despite the low dosage , the side effects it caused forced 15 % of the patients ab and on the treatment

An acceptability analysis showed that SSRIs were generally well tolerated . Conclusions These results suggest that there is insufficient evidence to reject the null hypothesis of no differences in efficacy between SSRIs and placebo in the treatment of depression in PD .

Background Selective serotonin reuptake inhibitors ( SSRIs ) are the most commonly prescribed antidepressants for the treatment of depression in patients with Parkinson 's Disease ( PD ) but data on their efficacy are controversial .

An acceptability analysis showed that SSRIs were generally well tolerated . Conclusions These results suggest that there is insufficient evidence to reject the null hypothesis of no differences in efficacy between SSRIs and placebo in the treatment of depression in PD .

Background Selective serotonin reuptake inhibitors ( SSRIs ) are the most commonly prescribed antidepressants for the treatment of depression in patients with Parkinson 's Disease ( PD ) but data on their efficacy are controversial .

Pramipexole versus sertraline in the treatment of depression in Parkinson’s disease

In addition to treating the motor symptoms of Parkinson ’s disease , the dopamine agonist pramipexole has shown an antidepressant effect . The trials , however , included patients with motor complications , raising the question of whether the antidepressant benefit represented only a treatment – related motor improvement . To address this issue , we have conducted a 14–week r and omized trial comparing pramipexole with an established antidepressant in patients without motor complications . At seven Italian centers , 67 Parkinsonian out patients with major depression but no history of motor fluctuations and /or dyskinesia received open – label pramipexole ( at 1.5 to 4.5 mg/day ) or sertraline ( at 50 mg/day ) . In both groups , the Hamilton Depression Rating Scale ( HAM – D ) score decreased throughout 12 weeks of treatment , but in the pramipexole group the proportion of patients who recovered , as defined by a final HAM – D score ≤ 8,was significantly higher , at 60.6 % versus 27.3 % ( p = 0.006 ) . Patients ’ self – ratings improved in both groups . All adverse events were mild or moderate , but five patients ( 14.7 % ) withdrew from the sertraline group . Despite the absence of motor complications , the pramipexole recipients showed improvement on the Unified Parkinson ’s Disease Rating Scale ( UPDRS ) motor subscore . We conclude that dopamine agonists may be an alternative to antidepressants in Parkinson ’s disease

An acceptability analysis showed that SSRIs were generally well tolerated . Conclusions These results suggest that there is insufficient evidence to reject the null hypothesis of no differences in efficacy between SSRIs and placebo in the treatment of depression in PD .

Background Selective serotonin reuptake inhibitors ( SSRIs ) are the most commonly prescribed antidepressants for the treatment of depression in patients with Parkinson 's Disease ( PD ) but data on their efficacy are controversial .

An acceptability analysis showed that SSRIs were generally well tolerated . Conclusions These results suggest that there is insufficient evidence to reject the null hypothesis of no differences in efficacy between SSRIs and placebo in the treatment of depression in PD .

Background Selective serotonin reuptake inhibitors ( SSRIs ) are the most commonly prescribed antidepressants for the treatment of depression in patients with Parkinson 's Disease ( PD ) but data on their efficacy are controversial .

Comparison of desipramine and citalopram treatments for depression in Parkinson's disease: a double-blind, randomized, placebo-controlled study.

Depression is one of the most common psychiatric disturbances in Parkinson 's disease ( PD ) . Recent review s have highlighted the lack of controlled trials and the ensuing difficulty in formulating recommendations for antidepressant use in PD . We sought to establish whether antidepressants provide real benefits and whether tricyclic and selective serotonin reuptake inhibitor ( SSRI ) antidepressants differ in their short-term efficacy , because the time to onset of therapeutic benefit remains an important criterion in depression . The short-term efficacy ( after 14 and 30 days ) of two antidepressants ( desipramine , a predominantly noradrenergic reuptake inhibitor tricyclic and citalopram , a SSRI ) was assessed in a double-blind , r and omized , placebo- controlled study of 48 nondemented PD patients suffering from major depression . After 14 days , desipramine prompted an improvement in the Montgomery Asberg Depression Rating Scale ( MADRS ) score , compared with citalopram and placebo . Both antidepressants produced significant improvements in the MADRS score after 30 days . Mild adverse events were twice as frequent in the desipramine group as in the other groups . A predominantly noradrenergic tricyclic antidepressant induced a more intense short-term effect on parkinsonian depression than did an SSRI . However , desipramine 's lower tolerability may outweigh its slight short-term clinical advantage

An acceptability analysis showed that SSRIs were generally well tolerated . Conclusions These results suggest that there is insufficient evidence to reject the null hypothesis of no differences in efficacy between SSRIs and placebo in the treatment of depression in PD .

Background Selective serotonin reuptake inhibitors ( SSRIs ) are the most commonly prescribed antidepressants for the treatment of depression in patients with Parkinson 's Disease ( PD ) but data on their efficacy are controversial .

An acceptability analysis showed that SSRIs were generally well tolerated . Conclusions These results suggest that there is insufficient evidence to reject the null hypothesis of no differences in efficacy between SSRIs and placebo in the treatment of depression in PD .

Background Selective serotonin reuptake inhibitors ( SSRIs ) are the most commonly prescribed antidepressants for the treatment of depression in patients with Parkinson 's Disease ( PD ) but data on their efficacy are controversial .

Randomized study of sertraline and low-dose amitriptyline in patients with Parkinson's disease and depression: effect on quality of life.

We assessed the effect of 3-month treatment of sertraline ( 50 mg ) or low-dose amitriptyline ( 25 mg ) on depression and quality of life in 31 patients with Parkinson 's disease in a prospect i ve single-blind r and omized study . Both drugs significantly reduced the Hamilton Depression Rating Scale ( HDRS-17 ) score . Completion rate was 75 % for sertraline ( 12 of 16 ) and 73 % for amitriptyline ( 11 of 15 ) . Responder rate ( HDRS-17 score reduction > /= 50 % ) was 83.3 % for sertraline and 72.7 % for amitriptyline . Sertraline but not amitriptyline treatment determined a significant benefit on quality of life ( PDQ-39 scale ) . We found no change in Unified Parkinson 's Disease Rating Scale scores . However , the improvement in specific PDQ-39 subscores ( mobility , activities of daily living , and stigma ) suggests that depression affects patient self-perception of motor function and further emphasizes the need for its treatment

An acceptability analysis showed that SSRIs were generally well tolerated . Conclusions These results suggest that there is insufficient evidence to reject the null hypothesis of no differences in efficacy between SSRIs and placebo in the treatment of depression in PD .

Background Selective serotonin reuptake inhibitors ( SSRIs ) are the most commonly prescribed antidepressants for the treatment of depression in patients with Parkinson 's Disease ( PD ) but data on their efficacy are controversial .

An acceptability analysis showed that SSRIs were generally well tolerated . Conclusions These results suggest that there is insufficient evidence to reject the null hypothesis of no differences in efficacy between SSRIs and placebo in the treatment of depression in PD .

Background Selective serotonin reuptake inhibitors ( SSRIs ) are the most commonly prescribed antidepressants for the treatment of depression in patients with Parkinson 's Disease ( PD ) but data on their efficacy are controversial .

Repetitive transcranial magnetic stimulation is as effective as fluoxetine in the treatment of depression in patients with Parkinson’s disease

Objective : To study the efficacy of 15 Hz repetitive transcranial magnetic stimulation ( rTMS ) in treating depression in patients with Parkinson ’s disease . Methods : 42 patients were enrolled into two groups : group 1 , active rTMS ( 15 Hz rTMS for 10 days ) and placebo drug treatment ; group 2 , sham rTMS and fluoxetine 20 mg/day . A specially design ed sham coil was used for sham stimulation . The unified Parkinson ’s disease rating scale ( UPDRS ) , activities of daily living ( ADL ) , Hamilton rating scale for depression ( HRSD ) , Beck depression inventory ( BDI ) , and mini-mental state examination ( MMSE ) were assessed by a rater blinded to treatment arm . Results : HRSD and BDI were improved to the same extent in both groups after two weeks of treatment ( 38 % and 32 % for group 1 , 41 % and 33 % for group 2 , respectively ) . At week 8 there was a tendency for worse motor UPDRS scores in group 2 ( NS ) . ADL showed improvement at week 8 only in group 1 . MMSE improved in both groups after treatment , but faster in group 1 than in group 2 . There were fewer adverse effects in group 1 than in group 2 . Conclusions : rTMS has the same antidepressant efficacy as fluoxetine and may have the additional advantage of some motor improvement and earlier cognitive improvement , with fewer adverse effects

An acceptability analysis showed that SSRIs were generally well tolerated . Conclusions These results suggest that there is insufficient evidence to reject the null hypothesis of no differences in efficacy between SSRIs and placebo in the treatment of depression in PD .

Background Selective serotonin reuptake inhibitors ( SSRIs ) are the most commonly prescribed antidepressants for the treatment of depression in patients with Parkinson 's Disease ( PD ) but data on their efficacy are controversial .

An acceptability analysis showed that SSRIs were generally well tolerated . Conclusions These results suggest that there is insufficient evidence to reject the null hypothesis of no differences in efficacy between SSRIs and placebo in the treatment of depression in PD .

Background Selective serotonin reuptake inhibitors ( SSRIs ) are the most commonly prescribed antidepressants for the treatment of depression in patients with Parkinson 's Disease ( PD ) but data on their efficacy are controversial .

The SSRI, Citalopram, Improves Bradykinesia in Patients With Parkinson's Disease Treated with L-Dopa

Idiopathic Parkinson 's disease ( IPD ) is characterized by motor signs such as akinesia , rigidity , and often tremor at rest . In addition to these symptoms , depression is a common finding affecting 40 % of patients with IPD . This study evaluates the effect of the selective serotonin reuptake inhibitor , citalopram , on motor and nonmotor symptoms of depressed and nondepressed patients with IPD . Forty-six nondemented patients with IPD ( 24 men , 22 women ; mean age 64 ± 5.3 years ; mean ± SD disease duration , 6.4 ± 3.2 years ; mean ± SD Hoehn-Yahr stage , 2.8 ± 1.2 ) were included in the study . Patients were divided in two subgroups : depressed ( n = 18 ) and nondepressed ( n = 28 ) . Citalopram was added in an unblinded manner , starting with 10 mg/d , and , after a week , increased up to 20 mg/d in the depressed subgroup ( n = 18 ) and in half of the nondepressed subgroup ( n = 14 ) . Parkinsonian and depressive symptoms were evaluated before and after 1 and 4 months of treatment . Statistical evaluation was made by analysis of variance for repeated measures . Citalopram did not worsen motor performance in IPD , but improved bradykinesia and finger taps after 1 month and 4 months of treatment both in patients with and without depression ( p < 0.05 versus baseline ) . A clear improvement in mood was also observed in 15 of 16 patients with depression . Although case reports indicate that citalopram can potentially worsen the motor symptoms in patients with PD , to date this effect has not been confirmed . Many of the symptoms , typically associated with depression , can be observed in nondepressed patients with IPD , because signs thought to represent depression can be produced by Parkinson 's disease . In this study , we observed that when combined with levodopa , citalopram induces an improvement of motor performance , in particular of subscores 23 and 31 of Unified Parkinson 's Disease Rating Scale both in depressed and in nondepressed patients with IPD

An acceptability analysis showed that SSRIs were generally well tolerated . Conclusions These results suggest that there is insufficient evidence to reject the null hypothesis of no differences in efficacy between SSRIs and placebo in the treatment of depression in PD .

Background Selective serotonin reuptake inhibitors ( SSRIs ) are the most commonly prescribed antidepressants for the treatment of depression in patients with Parkinson 's Disease ( PD ) but data on their efficacy are controversial .

An acceptability analysis showed that SSRIs were generally well tolerated . Conclusions These results suggest that there is insufficient evidence to reject the null hypothesis of no differences in efficacy between SSRIs and placebo in the treatment of depression in PD .

Background Selective serotonin reuptake inhibitors ( SSRIs ) are the most commonly prescribed antidepressants for the treatment of depression in patients with Parkinson 's Disease ( PD ) but data on their efficacy are controversial .

Does Nefazodone Improve Both Depression and Parkinson Disease? A Pilot Randomized Trial

Some of the selective serotonin reuptake inhibitors (SSRI)-induced motor side effects are mediated by stimulating 5-HT2 receptors in the basal ganglia , probably because serotonin inhibits the subsequent neuronal dopamine release . We hypothesized that nefazodone , a serotonin 2 antagonist/reuptake inhibitor ( SARI ) that selectively blocks 5-HT2 receptors , could disrupt the aforementioned inhibitory pathway . Therefore , increased dopamine levels in the postsynaptic milieu and an improvement in the motor symptoms in depressed patients with Parkinson disease ( PD ) should be observed . This study was design ed to determine whether nefazodone has a dual activity as an antidepressant and as an agent capable of reducing the extrapyramidal symptoms in depressed parkinsonian patients . Depressed patients with PD were r and omly assigned to 2 therapeutic groups : nefazodone or fluoxetine . Patients were evaluated by a psychiatrist and were blindly assessed by a neurologist with an array of scales . Patients on nefazodone ( n = 9 ) showed a significant improvement over time in the total Unified Parkinson Disease Rating Scale score ( UPDRS ) ( part II + part III ) ( P = 0.004 ) and in the UPDRS subscore part III ( P = 0.003 ) . None of these scores changed over time in the fluoxetine group ( n = 7 ) . Both , nefazodone and fluoxetine were equally effective as antidepressants : Beck Depression Inventory scores significantly improved ( P < 0.001 ) , with no significant differences between treatment groups ( P = 0.97 ) . If our results can be confirmed in a larger clinical trial , nefazodone ought to be considered over fluoxetine given its secondary beneficial effects regarding the reduction of extrapyramidal symptoms in depressed PD patients

An acceptability analysis showed that SSRIs were generally well tolerated . Conclusions These results suggest that there is insufficient evidence to reject the null hypothesis of no differences in efficacy between SSRIs and placebo in the treatment of depression in PD .

Background Selective serotonin reuptake inhibitors ( SSRIs ) are the most commonly prescribed antidepressants for the treatment of depression in patients with Parkinson 's Disease ( PD ) but data on their efficacy are controversial .

The overall results of r and om effects modelling of football heading were found to be inconclusive across all outcomes , groups and time points . No moderating variables related to method ological , sample or study characteristics were supported in the analysis ; age was a potential moderating variable . Summary / conclusions We provide the first meta-analytical review of football heading effects aggregated from multiple studies and extended findings from a recent systematic review of the effects of football heading . Our analysis indicates no overall effect for heading a football on adverse outcomes

Aim / objective The objective of this study was to provide a meta- analysis examining the effects of football heading . Design Meta-analytical review on football heading effects on neurocognitive performance , cognition and symptom reports .

The relationship between impact force, neck strength, and neurocognitive performance in soccer heading in adolescent females.

Head impacts are common in contact sports , but only recently has there been a rising awareness of the effects of subconcussive impacts in adolescent athletes . A better underst and ing of how to attenuate head impacts is needed and therefore , this study investigated the relationship between neck strength , impact , and neurocognitive function in an acute bout of soccer heading in a sample of female high school varsity soccer players . Seventeen participants completed the ImPACT neurocognitive test and had their isometric neck strength tested ( flexion , extension , and bilateral flexion ) before heading drills . Each participant was outfitted with custom headgear with timing switches and a three-dimensional accelerometer affixed to the back of the head , which allowed for measurement of impact during heading . Participants performed a series of 15 directional headers , including 5 forward , 5 left and 5 right headers in a r and om order , then completed the ImPACT test again . Neurocognitive tests revealed no significant changes following heading . However , there were statistically significant , moderate , negative correlations ( r = -0.500:-0.757 , p < .05 ) between neck strength and result ant header acceleration , indicating that those with weaker necks sustained greater impacts . This suggests neck strengthening may be an important component of any head injury prevention/reduction program

The overall results of r and om effects modelling of football heading were found to be inconclusive across all outcomes , groups and time points . No moderating variables related to method ological , sample or study characteristics were supported in the analysis ; age was a potential moderating variable . Summary / conclusions We provide the first meta-analytical review of football heading effects aggregated from multiple studies and extended findings from a recent systematic review of the effects of football heading . Our analysis indicates no overall effect for heading a football on adverse outcomes

Aim / objective The objective of this study was to provide a meta- analysis examining the effects of football heading . Design Meta-analytical review on football heading effects on neurocognitive performance , cognition and symptom reports .

The overall results of r and om effects modelling of football heading were found to be inconclusive across all outcomes , groups and time points . No moderating variables related to method ological , sample or study characteristics were supported in the analysis ; age was a potential moderating variable . Summary / conclusions We provide the first meta-analytical review of football heading effects aggregated from multiple studies and extended findings from a recent systematic review of the effects of football heading . Our analysis indicates no overall effect for heading a football on adverse outcomes

Aim / objective The objective of this study was to provide a meta- analysis examining the effects of football heading . Design Meta-analytical review on football heading effects on neurocognitive performance , cognition and symptom reports .

Effect of an acute bout of soccer heading on postural control and self-reported concussion symptoms.

Our purpose was to determine if an acute bout of heading soccer balls adversely affected postural control and self-reported symptoms of cerebral concussion . Thirty-one college-aged soccer players were r and omly placed into either a kicking group or a heading group . Subjects either kicked or headed 18 soccer balls over the course of 40 minutes . Subjects had their postural control assessed while st and ing on a force plate and completed a concussion symptoms checklist on three separate occasions : prior to , immediately following , and 24 hours after kicking or heading . There were no significant differences between the heading and kicking groups on the postural control measures prior to , immediately following , and 24 hours after kicking/heading . The heading group did , however , report significantly more concussion symptoms than the kicking group immediately after heading , but not 24 hours after heading . The number of previous concussions sustained by subjects did not influence the effects of heading . An acute bout of soccer heading appears to cause an increase in self-reported symptoms of cerebral concussion lasting less than 24 hours but no quantifiable deficits in postural control . Further research is needed to investigate the cumulative effects of soccer heading on postural control and other objective measures of brain function

The overall results of r and om effects modelling of football heading were found to be inconclusive across all outcomes , groups and time points . No moderating variables related to method ological , sample or study characteristics were supported in the analysis ; age was a potential moderating variable . Summary / conclusions We provide the first meta-analytical review of football heading effects aggregated from multiple studies and extended findings from a recent systematic review of the effects of football heading . Our analysis indicates no overall effect for heading a football on adverse outcomes

Aim / objective The objective of this study was to provide a meta- analysis examining the effects of football heading . Design Meta-analytical review on football heading effects on neurocognitive performance , cognition and symptom reports .

The overall results of r and om effects modelling of football heading were found to be inconclusive across all outcomes , groups and time points . No moderating variables related to method ological , sample or study characteristics were supported in the analysis ; age was a potential moderating variable . Summary / conclusions We provide the first meta-analytical review of football heading effects aggregated from multiple studies and extended findings from a recent systematic review of the effects of football heading . Our analysis indicates no overall effect for heading a football on adverse outcomes

Aim / objective The objective of this study was to provide a meta- analysis examining the effects of football heading . Design Meta-analytical review on football heading effects on neurocognitive performance , cognition and symptom reports .

Effect of soccer heading ball speed on S100B, sideline concussion assessments and head impact kinematics

Abstract Objective : To examine the effect of soccer heading ball speed on S-100B serum concentration , concussion sideline assessment s and linear head impact acceleration . Methods : Sixteen division I soccer players participated in this pre-test post-test design study . Athletes performed five st and ing headers over a 10 minute period at 30 ( n = 5 ) , 40 ( n = 5 ) or 50 ( n = 6 ) miles per hour ( mph ) ( r and omized ) . S-100B serum concentration ( ng mL−1 ) and sideline concussion assessment s were measured prior to and post-heading . Peak result ant linear head acceleration ( gravitational units ; g ) was measured during soccer heading . Results : No statistically significant interaction effects were identified between ball velocity groups over time on S100B ( effect sizes ranged from 0.03–0.23 ) or concussion assessment s tests . There was a non-significant increase ( p = 0.06 ) in head impact acceleration from the 30 ( 30.6 ; SD = 6.2 g ) to 50 mph ( 50.7 ; SD = 7.7 g ) ball speed . Conclusions : In this controlled setting , an acute bout of soccer heading across various ball velocities did not affect S100B or concussion assessment test scores . These findings are preliminary , as the small sample size in each group may have played a role in the lack of significant findings

The overall results of r and om effects modelling of football heading were found to be inconclusive across all outcomes , groups and time points . No moderating variables related to method ological , sample or study characteristics were supported in the analysis ; age was a potential moderating variable . Summary / conclusions We provide the first meta-analytical review of football heading effects aggregated from multiple studies and extended findings from a recent systematic review of the effects of football heading . Our analysis indicates no overall effect for heading a football on adverse outcomes

Aim / objective The objective of this study was to provide a meta- analysis examining the effects of football heading . Design Meta-analytical review on football heading effects on neurocognitive performance , cognition and symptom reports .

The overall results of r and om effects modelling of football heading were found to be inconclusive across all outcomes , groups and time points . No moderating variables related to method ological , sample or study characteristics were supported in the analysis ; age was a potential moderating variable . Summary / conclusions We provide the first meta-analytical review of football heading effects aggregated from multiple studies and extended findings from a recent systematic review of the effects of football heading . Our analysis indicates no overall effect for heading a football on adverse outcomes

Aim / objective The objective of this study was to provide a meta- analysis examining the effects of football heading . Design Meta-analytical review on football heading effects on neurocognitive performance , cognition and symptom reports .

Head Impact Exposure During a Weekend Youth Soccer Tournament

Concussion is a known risk in youth soccer , but little is known about subconcussive head impacts . The authors provided a prospect i ve cohort study measuring frequency and magnitude of subconcussive head impacts using accelerometry in a middle school – age soccer tournament , and association between head impacts and changes in ( 1 ) symptoms , ( 2 ) cognitive testing , and ( 3 ) advanced neuroimaging . A total of 17 youth completed the study ( 41 % female , mean 12.6 years ) . There were 73 head impacts > 15 g measured ( 45 % headers ) and only 2 had a maximum peak linear acceleration > 50 g . No youth reported symptoms consistent with concussion . After correction for multiple comparisons and a sensitivity analysis excluding clear outliers , no significant associations were found between head impact exposure and neuropsychological testing or advanced neuroimaging . The authors conclude that head impacts were relatively uncommon and low in acceleration in youth playing a weekend soccer tournament . This study adds to the limited data regarding head impacts in youth soccer

The overall results of r and om effects modelling of football heading were found to be inconclusive across all outcomes , groups and time points . No moderating variables related to method ological , sample or study characteristics were supported in the analysis ; age was a potential moderating variable . Summary / conclusions We provide the first meta-analytical review of football heading effects aggregated from multiple studies and extended findings from a recent systematic review of the effects of football heading . Our analysis indicates no overall effect for heading a football on adverse outcomes

Aim / objective The objective of this study was to provide a meta- analysis examining the effects of football heading . Design Meta-analytical review on football heading effects on neurocognitive performance , cognition and symptom reports .

The overall results of r and om effects modelling of football heading were found to be inconclusive across all outcomes , groups and time points . No moderating variables related to method ological , sample or study characteristics were supported in the analysis ; age was a potential moderating variable . Summary / conclusions We provide the first meta-analytical review of football heading effects aggregated from multiple studies and extended findings from a recent systematic review of the effects of football heading . Our analysis indicates no overall effect for heading a football on adverse outcomes

Aim / objective The objective of this study was to provide a meta- analysis examining the effects of football heading . Design Meta-analytical review on football heading effects on neurocognitive performance , cognition and symptom reports .

Relationship of soccer heading to computerized neurocognitive performance and symptoms among female and male youth soccer players

Primary objective : The purpose of this study was to investigate the relationship between soccer heading and computerized neurocognitive performance and symptoms in female and male youth soccer players . Research design : Cross-sectional and prospect i ve design . Methods and procedures : A total of 63 ( 27 females , 36 males ) youth soccer players aged 13–18 years ( M = 15.89 , SD = 1.17 ) participated in the study . Participants completed the Immediate Post-concussion Assessment and Cognitive Test ( ImPACT ) and symptom report . Main outcomes : Computerized neurocognitive performance ( e.g. , verbal and visual memory , motor processing , and reaction time ) and symptoms . Results : There were no differences in neurocognitive performance or symptoms among low- , moderate- , and high-exposure header groups . The current sample outperformed the 10th percentile norms for neurocognitive and symptom scores . Males headed the ball more frequently and reported lower verbal and visual memory and motor processing speed scores than females . Conclusion : The current findings did not support a relationship between soccer heading and computerized neurocognitive performance and symptoms . The research ers suggest that any purported effects of soccer heading in youth are subtle and may affect only a small number of athletes . The reported sex differences in heading exposure warrant further attention

The overall results of r and om effects modelling of football heading were found to be inconclusive across all outcomes , groups and time points . No moderating variables related to method ological , sample or study characteristics were supported in the analysis ; age was a potential moderating variable . Summary / conclusions We provide the first meta-analytical review of football heading effects aggregated from multiple studies and extended findings from a recent systematic review of the effects of football heading . Our analysis indicates no overall effect for heading a football on adverse outcomes

Aim / objective The objective of this study was to provide a meta- analysis examining the effects of football heading . Design Meta-analytical review on football heading effects on neurocognitive performance , cognition and symptom reports .

The overall results of r and om effects modelling of football heading were found to be inconclusive across all outcomes , groups and time points . No moderating variables related to method ological , sample or study characteristics were supported in the analysis ; age was a potential moderating variable . Summary / conclusions We provide the first meta-analytical review of football heading effects aggregated from multiple studies and extended findings from a recent systematic review of the effects of football heading . Our analysis indicates no overall effect for heading a football on adverse outcomes

Aim / objective The objective of this study was to provide a meta- analysis examining the effects of football heading . Design Meta-analytical review on football heading effects on neurocognitive performance , cognition and symptom reports .

The Acute Neuropsychological Effects of Heading in Soccer: A Pilot Study

Objective The main objective of this study was to prospect ively examine the acute effects of heading in soccer on cognitive function . Design This was a prospect i ve cross-over study using a brief neuropsychological battery to assess cognitive function . The tests were performed before and after two separate practice sessions , with athletes serving as their own controls . Setting Male and female Division I college athletes . Participants Members of the men 's and women 's varsity collegiate Penn State University soccer teams . Forty-four males and 56 females entered and finished the study . All athletes had a normal physical examination . Interventions Before and after both practice sessions , all athletes had a brief battery of neuropsychological tests and a symptom checklist . Main Outcome Measures Neuropsychological tests symptom checklist compared at baseline with those after the practice sessions . Results There were no significant differences in pretest scores between groups and no difference on posttest scores between heading and nonheading groups . A significant difference was detected using MANOVA ( p = < 0.001 ) between pre- and posttest scores for measures of attention and concentration , indicating a practice effect . A gender-specific effect in one test measuring attention and concentration was found . There was no difference in symptoms before and after heading as compared with exertional controls . Conclusions In this study , soccer players heading the ball does not appear to lead to acute changes in cognitive function as assessed by a brief neuropsychological battery . There are practice effects that occur with repetitive neuropsychological testing and gender differences with certain tests

The overall results of r and om effects modelling of football heading were found to be inconclusive across all outcomes , groups and time points . No moderating variables related to method ological , sample or study characteristics were supported in the analysis ; age was a potential moderating variable . Summary / conclusions We provide the first meta-analytical review of football heading effects aggregated from multiple studies and extended findings from a recent systematic review of the effects of football heading . Our analysis indicates no overall effect for heading a football on adverse outcomes

Aim / objective The objective of this study was to provide a meta- analysis examining the effects of football heading . Design Meta-analytical review on football heading effects on neurocognitive performance , cognition and symptom reports .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Rosuvastatin in the Prevention of Stroke Among Men and Women With Elevated Levels of C-Reactive Protein: Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER)

Background — Prior primary prevention trials of statin therapy that used cholesterol criteria for enrollment have not reported significant decreases in stroke risk . We evaluated whether statin therapy might reduce stroke rates among individuals with low levels of cholesterol but elevated levels of high-sensitivity C-reactive protein . Methods and Results — In Justification for the Use of statins in Prevention : an Intervention Trial Evaluating Rosuvastatin ( JUPITER ) , 17 802 apparently healthy men and women with low-density lipoprotein cholesterol levels < 130 mg/dL and high-sensitivity C-reactive protein levels ≥2.0 mg/L were r and omly allocated to rosuvastatin 20 mg daily or placebo and then followed up for the occurrence of a first stroke . After a median follow-up of 1.9 years ( maximum , 5.0 years ) , rosuvastatin result ed in a 48 % reduction in the hazard of fatal and nonfatal stroke as compared with placebo ( incidence rate , 0.18 and 0.34 per 100 person-years of observation , respectively ; hazard ratio 0.52 ; 95 % confidence interval , 0.34 to 0.79 ; P=0.002 ) , a finding that was consistent across all examined subgroups . This finding was due to a 51 % reduction in the rate of ischemic stroke ( hazard ratio , 0.49 ; 95 % confidence interval , 0.30 to 0.81 ; P=0.004 ) , with no difference in the rates of hemorrhagic stroke between the active and placebo arms ( hazard ratio , 0.67 ; 95 % confidence interval , 0.24 to 1.88 ; P=0.44 ) . Conclusion — Rosuvastatin reduces by more than half the incidence of ischemic stroke among men and women with low levels of low-density lipoprotein cholesterol levels who are at risk because of elevated levels of high-sensitivity C-reactive protein . Clinical Trial Registration — clinical trial.gov . Unique identifier : NCT00239681

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Testing cognitive function in elderly populations: the PROSPER study

Objectives : For large scale follow up studies with non-demented patients in which cognition is an endpoint , there is a need for short , inexpensive , sensitive , and reliable neuropsychological tests that are suitable for repeated measurements . The commonly used Mini-Mental-State-Examination fulfils only the first two requirements . Methods : In the PROspect i ve Study of Pravastatin in the Elderly at Risk ( PROSPER ) , 5804 elderly subjects aged 70 to 82 years were examined using a learning test ( memory ) , a coding test ( general speed ) , and a short version of the Stroop test ( attention ) . Data presented here were collected at dual baseline , before r and omisation for active treatment . Results : The tests proved to be reliable ( with test/retest reliabilities ranging from acceptable ( r=0.63 ) to high ( r=0.88 ) and sensitive to detect small differences in subjects from different age categories . All tests showed significant practice effects : performance increased from the first measurement to the first follow up after two weeks . Conclusion : Normative data are provided that can be used for one time neuropsychological testing as well as for assessing individual and group change . Methods for analysing cognitive change are proposed

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

An Economic Evaluation of Atorvastatin for Primary Prevention of Cardiovascular Events in Type 2 Diabetes

Objective The CARDS trial , a multicentre , r and omized , controlled trial , found that atorvastatin 10 mg/day for patients with type 2 diabetes mellitus and normal low-density lipoprotein (LDL)-cholesterol significantly reduced cardiovascular ( CV ) events , including stroke . We estimated the cost effectiveness of atorvastatin as primary prevention against CV disease from the short-term and lifetime US payer perspectives . Research design and methods We constructed a decision analytic ( Markov ) model to evaluate long-term costs and outcomes for atorvastatin 10 mg/day versus no HMG-CoA reductase inhibitor ( statin ) therapy for patients with type 2 diabetes and no history of a CV event . CV event rates and survival were based on risk equations calibrated to CARDS and applied to a US type 2 diabetes population ; the atorvastatin effect on CV events was based on hazard ratios from CARDS ; direct medical care costs were based on US treatment patterns and published costs analyses of patients with diabetes . Costs were valued in $ US , year 2005 values ; costs and benefits were discounted at 3 % per annum . Results Within the time horizon of the trial ( 5 years ) , the cost effectiveness of atorvastatin was $ US137 276 per QALY . At 10 years , the incremental cost per QALY improved to $ US3640 per QALY . At 25 years , overall costs were lower and QALYs higher in the atorvastatin arm . Costs of managing CV events were lower after 5 years for patients treated with atorvastatin . Conclusions For patients with type 2 diabetes and one additional risk factor for CV disease , normal LDL-cholesterol and no history of a CV event , primary prevention with atorvastatin appears to be cost saving and improve outcomes over 25 years , although it is costly from a short-term US payer perspective . From both a medical and an economic viewpoint , primary prevention is desirable in this patient population

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Stroke prediction and stroke prevention with atorvastatin in the Collaborative Atorvastatin Diabetes Study (CARDS)

Aims Patients with Type 2 diabetes have an elevated risk of stroke . The role of lipid levels and diabetes‐specific factors in risk prediction of stroke is unclear , and estimates of efficacy of lipid‐lowering therapy vary between trials . We examined predictors of stroke and the effect of atorvastatin on specific stroke subtypes in Type 2 diabetes in the Collaborative Atorvastatin Diabetes Study ( CARDS ) [ a trial of 2838 participants with mean low‐density lipoprotein cholesterol < 4.14 mmol/l , no history of macrovascular disease and r and omized to atorvastatin 10 mg daily or placebo ]

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Pravastatin for Cardiovascular Event Primary Prevention in Patients With Mild-to-Moderate Hypertension in the Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese (MEGA) Study

Lipid-lowering therapy in individuals with high risk of cardiovascular disease reduces the incidence of coronary heart disease . However , few studies have assessed the benefits of cholesterol lowering for primary prevention of coronary heart disease in hypertensive patients with mild dyslipidemia or without conventional dyslipidemia . The large , r and omized Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese Study showed a 33 % reduction in coronary heart disease incidence with pravastatin as the primary prevention in Japanese patients . We conducted an exploratory analysis of the effect of diet plus pravastatin therapy on the primary prevention of cardiovascular events ( coronary heart disease , coronary heart disease plus cerebral infa rct ion , and cardiovascular disease ) in the 3277 patients with hypertension during the 5-year follow-up . There were no significant differences in mean baseline total cholesterol , blood pressure levels , or variation in blood pressure during the 5-year period between the diet ( n=1664 ) and diet plus pravastatin ( n=1613 ) groups . In the diet plus pravastatin group , the relative risk of coronary heart disease plus cerebral infa rct ion was reduced by 35 % ( hazard ratio : 0.65 ; CI : 0.46 to 0.93 ; P=0.02 ) , cerebral infa rct ion by 46 % ( hazard ratio : 0.54 ; CI : 0.29 to 0.98 ; P=0.04 ) , and cardiovascular disease by 33 % ( hazard ratio : 0.67 ; CI : 0.49 to 0.91 ; P=0.01 ) . In patients without a history of cardiovascular disease who have hypertension and mildly elevated cholesterol , pravastatin was effective in reducing the incidence of cardiovascular disease , particularly cerebral infa rct ion . Hence , in patients with hypertension with mildly elevated cholesterol levels , treatment with a statin is advisable to reduce the burden of cardiovascular disease

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events?

CONTEXT Previous studies indicate that industry-sponsored trials tend to draw proindustry conclusions . OBJECTIVE To explore whether the association between funding and conclusions in r and omized drug trials reflects treatment effects or adverse events . DESIGN Observational study of 370 r and omized drug trials included in meta-analyses from Cochrane review s selected from the Cochrane Library , May 2001 . From a r and om sample of 167 Cochrane review s , 25 contained eligible meta-analyses ( assessed a binary outcome ; pooled at least 5 full-paper trials of which at least 1 reported adequate and 1 reported inadequate allocation concealment ) . The primary binary outcome from each meta- analysis was considered the primary outcome for all trials included in each meta- analysis . The association between funding and conclusions was analyzed by logistic regression with adjustment for treatment effect , adverse events , and additional confounding factors ( method ological quality , control intervention , sample size , publication year , and place of publication ) . MAIN OUTCOME MEASURE Conclusions in trials , classified into whether the experimental drug was recommended as the treatment of choice or not . RESULTS The experimental drug was recommended as treatment of choice in 16 % of trials funded by nonprofit organizations , 30 % of trials not reporting funding , 35 % of trials funded by both nonprofit and for-profit organizations , and 51 % of trials funded by for-profit organizations ( P<.001 ; chi2 test ) . Logistic regression analyses indicated that funding , treatment effect , and double blinding were the only significant predictors of conclusions . Adjusted analyses showed that trials funded by for-profit organizations were significantly more likely to recommend the experimental drug as treatment of choice ( odds ratio , 5.3 ; 95 % confidence interval , 2.0 - 14.4 ) compared with trials funded by nonprofit organizations . This association did not appear to reflect treatment effect or adverse events . CONCLUSIONS Conclusions in trials funded by for-profit organizations may be more positive due to biased interpretation of trial results . Readers should carefully evaluate whether conclusions in r and omized trials are supported by data

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Effects of simvastatin 40 mg daily on muscle and liver adverse effects in a 5-year randomized placebo-controlled trial in 20,536 high-risk people

Background Simvastatin reduces cardiovascular mortality and morbidity but , as with other HMG-CoA reductase inhibitors , can cause significant muscle toxicity and has been associated with elevations of liver transaminases . Methods Muscle and liver adverse effects of simvastatin 40 mg daily were evaluated in a r and omized placebo-controlled trial involving 20,536 UK patients with vascular disease or diabetes ( in which a substantial reduction of cardiovascular mortality and morbidity has previously been demonstrated ) . Results The excess incidence of myopathy in the simvastatin group was < 0.1 % over the 5 years of the trial , and there were no significant differences between the treatment groups in the incidence of serious hepatobiliary disease . Conclusion Among the many different types of high-risk patient studied ( including women , older individuals and those with low cholesterol levels ) , there was a very low incidence ( < 0.1 % ) of myopathy during 5 years treatment with simvastatin 40 mg daily . The risk of hepatitis , if any , was undetectable even in this very large long-term trial . Routine monitoring of liver function tests during treatment with simvastatin 40 mg is not useful . Trial Registration IS RCT

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein.

BACKGROUND Increased levels of the inflammatory biomarker high-sensitivity C-reactive protein predict cardiovascular events . Since statins lower levels of high-sensitivity C-reactive protein as well as cholesterol , we hypothesized that people with elevated high-sensitivity C-reactive protein levels but without hyperlipidemia might benefit from statin treatment . METHODS We r and omly assigned 17,802 apparently healthy men and women with low-density lipoprotein ( LDL ) cholesterol levels of less than 130 mg per deciliter ( 3.4 mmol per liter ) and high-sensitivity C-reactive protein levels of 2.0 mg per liter or higher to rosuvastatin , 20 mg daily , or placebo and followed them for the occurrence of the combined primary end point of myocardial infa rct ion , stroke , arterial revascularization , hospitalization for unstable angina , or death from cardiovascular causes . RESULTS The trial was stopped after a median follow-up of 1.9 years ( maximum , 5.0 ) . Rosuvastatin reduced LDL cholesterol levels by 50 % and high-sensitivity C-reactive protein levels by 37 % . The rates of the primary end point were 0.77 and 1.36 per 100 person-years of follow-up in the rosuvastatin and placebo groups , respectively ( hazard ratio for rosuvastatin , 0.56 ; 95 % confidence interval [ CI ] , 0.46 to 0.69 ; P<0.00001 ) , with corresponding rates of 0.17 and 0.37 for myocardial infa rct ion ( hazard ratio , 0.46 ; 95 % CI , 0.30 to 0.70 ; P=0.0002 ) , 0.18 and 0.34 for stroke ( hazard ratio , 0.52 ; 95 % CI , 0.34 to 0.79 ; P=0.002 ) , 0.41 and 0.77 for revascularization or unstable angina ( hazard ratio , 0.53 ; 95 % CI , 0.40 to 0.70 ; P<0.00001 ) , 0.45 and 0.85 for the combined end point of myocardial infa rct ion , stroke , or death from cardiovascular causes ( hazard ratio , 0.53 ; 95 % CI , 0.40 to 0.69 ; P<0.00001 ) , and 1.00 and 1.25 for death from any cause ( hazard ratio , 0.80 ; 95 % CI , 0.67 to 0.97 ; P=0.02 ) . Consistent effects were observed in all subgroups evaluated . The rosuvastatin group did not have a significant increase in myopathy or cancer but did have a higher incidence of physician-reported diabetes . CONCLUSIONS In this trial of apparently healthy persons without hyperlipidemia but with elevated high-sensitivity C-reactive protein levels , rosuvastatin significantly reduced the incidence of major cardiovascular events . ( Clinical Trials.gov number , NCT00239681 .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Effect of lovastatin on primary prevention of cardiovascular events in mild CKD and kidney function loss: a post hoc analysis of the Air Force/Texas Coronary Atherosclerosis Prevention Study.

BACKGROUND Chronic kidney disease ( CKD ) is associated with an increased risk of incident cardiovascular disease ( CVD ) ; however , the role of statins for the primary prevention of acute cardiovascular events in patients with CKD and the effect of statins on kidney function loss in persons without prevalent CVD have not been studied . STUDY DESIGN Post hoc analysis of the Air Force/Texas Coronary Atherosclerosis Prevention Study . SETTING & PARTICIPANTS Multicenter , r and omized , double-blind , placebo-controlled trial of 5,608 men and 997 women without CVD r and omly assigned to treatment with lovastatin or placebo . INTERVENTION Placebo or lovastatin , 20 mg/d . OUTCOMES & MEASUREMENTS First major acute cardiovascular event in participants with mild CKD and kidney function loss in persons with or without CKD . Estimated glomerular filtration rate was calculated using the 4-variable Modification of Diet in Renal Disease Study equation . RESULTS At baseline , mean estimated glomerular filtration rate in participants with CKD ( n = 304 ) was 53.0 + /- 6.0 mL/min/1.73 m(2 ) . After an average follow-up of 5.3 + /- 0.8 years , the incidence of a fatal and nonfatal CVD event was lower in participants with CKD receiving lovastatin than in those receiving placebo ( adjusted relative risk [ RR ] , 0.31 ; 95 % CI , 0.13 - 0.72 ; P = 0.01 ) . Tests for interaction suggested that the benefit of lovastatin was independent of the presence of CKD . Lovastatin did not reduce the annualized mean decrease in estimated glomerular filtration rate ( -1.3 + /- 0.07 vs -1.4 + /- 0.07 mL/min/1.73 m(2)/y , respectively ; P = 0.1 ) or the frequency of a > or = 25 % decrease in kidney function ( adjusted RR , 1.10 ; 95 % CI , 0.96 - 1.28 ; P = 0.2 ) or incident CKD ( adjusted RR , 1.04 ; 95 % CI , 0.86 - 1.27 ; P = 0.6 ) . LIMITATIONS Unable to determine the cause and duration of kidney disease , and information regarding proteinuria was not available . CONCLUSIONS Lovastatin is effective for the primary prevention of CVD in patients with CKD , but is not effective in decreasing kidney function loss in persons with no CVD

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

[Pravastatin in the treatment of primary hypercholesterolemia: a Swiss multicenter study].

Conventional lipid-lowering agents displayed only limited efficacy in lowering total and LDL cholesterol and a high incidence of side effects . Pravastatin is a new potent cholesterol-lowering agent , which selectively inhibits hepatic HMG-CoA-reductase . In a double-blind , placebo-controlled Swiss multicenter study with determination of lipids and lipoprotein in a central laboratory , the efficacy and safety of 6 months ' therapy with pravastatin was evaluated in 50 patients with mild hypercholesterolemia and additional coronary risk factors . Compared to baseline and after 26 weeks ' therapy , pravastatin significantly reduced total cholesterol ( pravastatin vs placebo , -17 % vs + 7 % , p < 0.0001 ) and LDL cholesterol ( -26 vs + 2 % , p < 0.0001 ) . The total/HDL cholesterol ratio ( = " atherogenic index " ) was comparable in the two groups at baseline ( 5.9 + /- 1.1 vs 6.3 + /- 0.9 ) , and was distinctly lowered by pravastatin but not placebo ( -20 vs 0 % , p < 0.0001 ) . In 11 patients in whom the reduction of serum total cholesterol after 13 weeks ' treatment with 20 mg pravastatin was still below target ( on average -9.1 % ) , doubling of the dose produced a further decrease of 4.3 % . Serum HDL cholesterol and serum triglyceride levels did not change significantly during pravastatin treatment as compared to baseline and placebo . Pravastatin was well tolerated during the 26 weeks without relevant subjective side-effects . There were 5 dropouts during the study , 2 patients in the pravastatin group and 3 in the placebo group . These findings document that pravastatin , administered in a single daily dose of 20 to 40 mg , effectively lowers serum cholesterol and total-/HDL-cholesterol improving action and is well tolerated

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Expanded clinical evaluation of lovastatin (EXCEL) study results: III. Efficacy in modifying lipoproteins and implications for managing patients with moderate hypercholesterolemia.

In the multicenter , double-blind EXCEL ( Exp and ed Clinical Evaluation of Lovastatin ) study the efficacy of lovastatin in modifying plasma lipids and lipoproteins in 8,245 participants with moderate primary hypercholesterolemia was evaluated . Patients were r and omly assigned to 48 weeks of treatment with diet and placebo or diet and lovastatin 20 or 40 mg once a day , or 20 or 40 mg twice a day . At all of these dosages , lovastatin produced substantial dose-dependent reductions in low-density-lipoprotein (LDL)-cholesterol levels , averaging 24 % ( 20 mg/day ) to 40 % ( 80 mg/day ) . The magnitude of the effect of this lipoprotein was further reflected by the percentage of patients who achieved National Cholesterol Education Program ( NCEP ) goals . In the absence of coronary artery disease ( CAD ) or two other CAD risk factors , the LDL-cholesterol goal of 4.14 mmol/L ( 160 mg/dL ) was attained by 22 % of patients in the placebo group and between 81 % ( 20 mg/day ) and 96 % ( 80 mg/day ) of those treated with lovastatin . For those with CAD or at least two other CAD risk factors , the LDL-cholesterol goal of 3.36 mmol/L ( 130 mg/dL ) was attained by 4 % of placebo patients and between 38 % ( 20 mg/day ) and 83 % ( 80 mg/day ) of those treated with lovastatin . Lovastatin also increased high-density-lipoprotein cholesterol ( 7 - 10 % ) and decreased triglycerides ( 10 - 19 % ) in a dose-dependent manner . Thus , when used as an adjunct to a prudent diet , lovastatin produces favorable changes in the entire lipoprotein profile and is a highly effective agent for managing patients with primary hypercholesterolemia

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

No effect of statin therapy on silent myocardial ischemia in patients with type 2 diabetes without manifest cardiovascular disease.

OBJECTIVE Coronary artery disease is the most important cause of mortality in patients with type 2 diabetes . We aim ed to determine the prevalence of silent myocardial ischemia ( SMI ) and the effect of statin therapy on SMI in type 2 diabetic patients without manifest cardiovascular disease . RESEARCH DESIGN AND METHODS A r and omized , placebo-controlled , double-blind trial was performed in 250 patients with type 2 diabetes without manifest cardiovascular disease . Patients were given either 0.4 mg cerivastatin or placebo daily . In August 2001 , when cerivastatin was withdrawn from the market , cerivastatin 0.4 mg was replaced by 20 mg simvastatin without deblinding the study . The primary end point was the change in ischemic episodes , duration , and burden as measured by 48-h ambulatory electrocardiography ( AECG ) over 2 years . RESULTS At baseline , 47 of 233 ( 20 % ) evaluable ambulatory electrocardiograms showed evidence of ischemia . After 2 years , there was a trend toward more ischemia in both treatment groups , without significant differences between the changes in ischemic parameters ( episodes P = 0.498 ; duration P = 0.697 ; burden P = 0.798 ) in the two treatment groups . Cardiovascular events occurred in 12 patients in the placebo group and in two patients in the statin group ( P = 0.006 ) . There was no relationship between these cardiovascular events and the presence of SMI at baseline . CONCLUSIONS SMI occurred in 20 % of type 2 diabetes patients without manifest cardiovascular disease . There was no effect from 2 years of statin therapy on SMI . In contrast , we observed a significantly lower cardiovascular event rate on statin therapy . AECG may not be a proper tool for risk stratification in patients with type 2 diabetes

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Effect of lower targets for blood pressure and LDL cholesterol on atherosclerosis in diabetes: the SANDS randomized trial.

CONTEXT Individuals with diabetes are at increased risk for cardiovascular disease ( CVD ) , but more aggressive targets for risk factor control have not been tested . OBJECTIVE To compare progression of sub clinical atherosclerosis in adults with type 2 diabetes treated to reach aggressive targets of low-density lipoprotein cholesterol ( LDL-C ) of 70 mg/dL or lower and systolic blood pressure ( SBP ) of 115 mm Hg or lower vs st and ard targets of LDL-C of 100 mg/dL or lower and SBP of 130 mm Hg or lower . DESIGN , SETTING , AND PARTICIPANTS A r and omized , open-label , blinded-to-end point , 3-year trial from April 2003-July 2007 at 4 clinical centers in Oklahoma , Arizona , and South Dakota . Participants were 499 American Indian men and women aged 40 years or older with type 2 diabetes and no prior CVD events . INTERVENTIONS Participants were r and omized to aggressive ( n=252 ) vs st and ard ( n=247 ) treatment groups with stepped treatment algorithms defined for both . MAIN OUTCOME MEASURES Primary end point was progression of atherosclerosis measured by common carotid artery intimal medial thickness ( IMT ) . Secondary end points were other carotid and cardiac ultrasonographic measures and clinical events . RESULTS Mean target LDL-C and SBP levels for both groups were reached and maintained . Mean ( 95 % confidence interval ) levels for LDL-C in the last 12 months were 72 ( 69 - 75 ) and 104 ( 101 - 106 ) mg/dL and SBP levels were 117 ( 115 - 118 ) and 129 ( 128 - 130 ) mm Hg in the aggressive vs st and ard groups , respectively . Compared with baseline , IMT regressed in the aggressive group and progressed in the st and ard group ( -0.012 mm vs 0.038 mm ; P < .001 ) ; carotid arterial cross-sectional area also regressed ( -0.02 mm(2 ) vs 1.05 mm(2 ) ; P < .001 ) ; and there was greater decrease in left ventricular mass index ( -2.4 g/m(2.7 ) vs -1.2 g/m(2.7 ) ; P = .03 ) in the aggressive group . Rates of adverse events ( 38.5 % and 26.7 % ; P = .005 ) and serious adverse events ( n = 4 vs 1 ; P = .18 ) related to blood pressure medications were higher in the aggressive group . Clinical CVD events ( 1.6/100 and 1.5/100 person-years ; P = .87 ) did not differ significantly between groups . CONCLUSIONS Reducing LDL-C and SBP to lower targets result ed in regression of carotid IMT and greater decrease in left ventricular mass in individuals with type 2 diabetes . Clinical events were lower than expected and did not differ significantly between groups . Further follow-up is needed to determine whether these improvements will result in lower long-term CVD event rates and costs and favorable risk-benefit outcomes . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00047424

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Breast self examination

A large well conducted r and omised controlled trial from Shanghai shows conclusively that teaching women how to examine their breasts does not lead to a reduction in mortality due to breast cancer compared with no screening at all.1 The findings should bring to an end more than decade of controversy and confusion in the United Kingdom concerning the efficacy and effectiveness of self examination of the breast . In September 1991 , in his retirement speech , Chief Medical Officer Sir Donald Acheson announced that breast self examination was not effective and may give a false sense of security . His remarks outraged women 's health campaigners , fuelled by a media frenzy in favour of breast self examination that lasted several weeks . The introduction of a policy of breast awareness shortly afterwards only added to the confusion . Rather than ritually checking their breasts at a specific time each month according to a set technique , women were encouraged to take responsibility for their own health by taking convenient opportunities such as bathing or dressing to become familiar with their breasts at different times of the month and

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Statin Use and Leg Functioning in Patients With and Without Lower-Extremity Peripheral Arterial Disease

Background —We determined whether statin use ( versus nonuse ) is associated with superior lower-extremity functioning independently of cholesterol levels and other confounders in patients with and without peripheral arterial disease . Methods and Results — Participants included 392 men and women with an ankle brachial index ( ABI ) < 0.90 and 249 with ABI 0.90 to 1.50 . Functional outcomes included 6-minute walk distance and 4-meter walking velocity . A summary performance score combined performance in walking speed , st and ing balance , and time for 5 repeated chair rises into an ordinal score ranging from 0 to 12 ( 12=best ) . Adjusting for age , sex , ABI , comorbidities , education level , medical insurance status , cholesterol , and other confounders , participants taking statins had better 6-minute walk performance ( 1276 versus 1218 feet , P = 0.045 ) , faster walking velocity ( 0.93 versus 0.89 m/s , P = 0.006 ) , and a higher summary performance score ( 10.2 versus 9.4 , P < 0.001 ) than participants not taking statins . Positive associations were attenuated slightly after additional adjustment for C-reactive protein level but remained statistically significant for walking velocity and the summary performance score . We did not find significant associations between lower-extremity functioning and aspirin , ACE inhibitors , vasodilators , or & bgr;-blockers . Conclusions —Statin use is associated with superior leg functioning compared with no statin use , independent of cholesterol levels and other potential confounders . These data suggest that non – cholesterol-lowering properties of statins may favorably influence functioning in persons with and without peripheral arterial disease

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Reduction of Heat Shock Protein Antibody Levels by Statin Therapy

Atherosclerosis is a disease whose pathogenesis involves inflammatory and immunological mechanisms , including an autoimmune reaction against heat shock proteins ( Hsps ) . The purpose of this study was to analyze whether the antiatherogenic effect of statin therapy was not limited to its lipid lowering effect , but also included anti-inflammatory and immunomodulatory effects , paying special attention to the measurement of circulating concentrations of anti-Hsp70 and anti-Hsp60 antibodies previously related to vascular disease . Two-hundred and seventy-five subjects aged 40–60 years , r and omly selected in an epidemiological study on the incidence of vascular risk factors , were studied . Laboratory tests included a complete lipid profile after a 12-h fast and measurements of glucose , C-reactive-protein , anti-Hsp70 and anti-Hsp60 antibodies . Subjects with hypercholesterolemia had significantly higher concentrations of anti-Hsp70 antibodies as compared to subjects with normal cholesterol concentrations . Statin therapy was associated with 11.63 and 15.3 % reductions in total and LDL-cholesterol ( P = 0.005 and 0.017 , respectively ) as compared to untreated subjects , and with lower concentrations of circulating anti-Hsp70 ( P = 0.016 ) antibodies . No differences were found in C-reactive-protein values . Since statin therapy not only reduces lipid profile , but also anti-Hsp70 and anti-Hsp60 antibody concentrations , without changing C-reactive-protein values , it is suggested that such an effect could not be accounted for by the anti-inflammatory properties of statins , but by their direct immunomodulatory properties through their effects on lymphocyte function

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

HDL cholesterol and residual risk of first cardiovascular events after treatment with potent statin therapy: an analysis from the JUPITER trial

BACKGROUND HDL-cholesterol concentrations are inversely associated with occurrence of cardiovascular events . We addressed , using the JUPITER trial cohort , whether this association remains when LDL-cholesterol concentrations are reduced to the very low ranges with high-dose statin treatment . METHODS Participants in the r and omised placebo-controlled JUPITER trial were adults without diabetes or previous cardiovascular disease , and had baseline concentrations of LDL cholesterol of less than 3.37 mmol/L and high-sensitivity C-reactive protein of 2 mg/L or more . Participants were r and omly allocated by a computer-generated sequence to receive rosuvastatin 20 mg per day or placebo , with participants and adjudicators masked to treatment assignment . In the present analysis , we divided the participants into quartiles of HDL-cholesterol or apolipoprotein A1 and sought evidence of association between these quartiles and the JUPITER primary endpoint of first non-fatal myocardial infa rct ion or stroke , hospitalisation for unstable angina , arterial revascularisation , or cardiovascular death . This trial is registered with Clinical Trials.gov , number NCT00239681 . FINDINGS For 17,802 patients in the JUPITER trial , rosuvastatin 20 mg per day reduced the incidence of the primary endpoint by 44 % ( p<0.0001 ) . In 8901 ( 50 % ) patients given placebo ( who had a median on-treatment LDL-cholesterol concentration of 2.80 mmol/L [ IQR 2.43 - 3.24 ] ) , HDL-cholesterol concentrations were inversely related to vascular risk both at baseline ( top quartile vs bottom quartile hazard ratio [ HR ] 0.54 , 95 % CI 0.35 - 0.83 , p=0.0039 ) and on-treatment ( 0.55 , 0.35 - 0.87 , p=0.0047 ) . By contrast , among the 8900 ( 50 % ) patients given rosuvastatin 20 mg ( who had a median on-treatment LDL-cholesterol concentration of 1.42 mmol/L [ IQR 1.14 - 1.86 ] ) , no significant relationships were noted between quartiles of HDL-cholesterol concentration and vascular risk either at baseline ( 1.12 , 0.62 - 2.03 , p=0.82 ) or on-treatment ( 1.03 , 0.57 - 1.87 , p=0.97 ) . Our analyses for apolipoprotein A1 showed an equivalent strong relation to frequency of primary outcomes in the placebo group but little association in the rosuvastatin group . INTERPRETATION Although measurement of HDL-cholesterol concentration is useful as part of initial cardiovascular risk assessment , HDL-cholesterol concentrations are not predictive of residual vascular risk among patients treated with potent statin therapy who attain very low concentrations of LDL cholesterol . FUNDING AstraZeneca

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial

BACKGROUND Although statins reduce coronary and cerebrovascular morbidity and mortality in middle-aged individuals , their efficacy and safety in elderly people is not fully established . Our aim was to test the benefits of pravastatin treatment in an elderly cohort of men and women with , or at high risk of developing , cardiovascular disease and stroke . METHODS We did a r and omised controlled trial in which we assigned 5804 men ( n=2804 ) and women ( n=3000 ) aged 70 - 82 years with a history of , or risk factors for , vascular disease to pravastatin ( 40 mg per day ; n=2891 ) or placebo ( n=2913 ) . Baseline cholesterol concentrations ranged from 4.0 mmol/L to 9.0 mmol/L. Follow-up was 3.2 years on average and our primary endpoint was a composite of coronary death , non-fatal myocardial infa rct ion , and fatal or non-fatal stroke . Analysis was by intention-to-treat . FINDINGS Pravastatin lowered LDL cholesterol concentrations by 34 % and reduced the incidence of the primary endpoint to 408 events compared with 473 on placebo ( hazard ratio 0.85 , 95 % CI 0.74 - 0.97 , p=0.014 ) . Coronary heart disease death and non-fatal myocardial infa rct ion risk was also reduced ( 0.81 , 0.69 - 0.94 , p=0.006 ) . Stroke risk was unaffected ( 1.03 , 0.81 - 1.31 , p=0.8 ) , but the hazard ratio for transient ischaemic attack was 0.75 ( 0.55 - 1.00 , p=0.051 ) . New cancer diagnoses were more frequent on pravastatin than on placebo ( 1.25 , 1.04 - 1.51 , p=0.020 ) . However , incorporation of this finding in a meta- analysis of all pravastatin and all statin trials showed no overall increase in risk . Mortality from coronary disease fell by 24 % ( p=0.043 ) in the pravastatin group . Pravastatin had no significant effect on cognitive function or disability . INTERPRETATION Pravastatin given for 3 years reduced the risk of coronary disease in elderly individuals . PROSPER therefore extends to elderly individuals the treatment strategy currently used in middle aged people

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

The design of a prospective study of Pravastatin in the Elderly at Risk (PROSPER). PROSPER Study Group. PROspective Study of Pravastatin in the Elderly at Risk.

The PROspect i ve Study of Pravastatin in the Elderly at Risk ( PROSPER ) is a r and omized , double-blind , placebo-controlled trial design ed to test the hypothesis that treatment with pravastatin will diminish risk of subsequent major vascular events in a cohort of men and women ( 70 to 82 years old ) with preexisting vascular disease or significant risk of developing this condition . Five thous and eight hundred four men and women in addition to receiving advice on diet and smoking , have been r and omized equally to treatment with 40 mg pravastatin/day or matching placebo in 3 centers ( Cork , Irel and , Glasgow , Scotl and , and Leiden , The Netherl and s ) . Following an average 3.5-year intervention period , a primary assessment will be made of the influence of this therapy on major vascular events ( a combination of coronary heart disease , death , nonfatal myocardial infa rct ion , and fatal and nonfatal stroke ) . A number of additional analyses will also be conducted on the individual components of the primary end point , on men , on women , and on subjects with and without previous evidence of vascular disease . Finally , an assessment will be made of the effects of treatment on cognitive function , disability , hospitalization or institutionalization , vascular mortality , and all-cause mortality

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Effects of Fosinopril and Pravastatin on Cardiovascular Events in Subjects With Microalbuminuria

Background —Microalbuminuria is associated with increased risk of cardiovascular events . We assessed whether therapeutic intervention aim ed at lowering urinary albumin excretion would reduce cardiovascular events in microalbuminuric subjects ( 15 to 300 mg/24 hours ) . Methods and Results —From the Prevention of Renal and Vascular Endstage Disease ( PREVEND ) cohort ( n=8592 ) , 1439 subjects fulfilled the inclusion criteria of the PREVEND Intervention Trial ( PREVEND IT ) . Of these subjects , 864 were r and omized to fosinopril 20 mg or matching placebo and to pravastatin 40 mg or matching placebo . The mean follow-up was 46 months , and the primary end point was cardiovascular mortality and hospitalization for cardiovascular morbidity . Mean age was 51±12 years ; 65 % of subjects were male , and 3.4 % had a previous cardiovascular event . Mean cholesterol level was 5.8±1.0 mmol/L , mean systolic/diastolic blood pressure was 130±18/76±10 mm Hg , and median urinary albumin excretion was 22.8 ( 15.8 to 41.3 ) mg/24 hours . The primary end point occurred in 45 subjects ( 5.2 % ) . Fosinopril reduced urinary albumin excretion by 26 % ( P<0.001 ) . Subjects treated with fosinopril showed a 40 % lower incidence of the primary end point ( hazard ratio 0.60 [ 95 % CI 0.33 to 1.10 ] , P=0.098 , log-rank ) . Pravastatin did not reduce urinary albumin excretion , and subjects treated with pravastatin showed a 13 % lower incidence of the primary end point than subjects in the placebo group ( 0.87 [ 0.49 to 1.57 ] , P=0.649 , log-rank ) . Conclusions —In microalbuminuric subjects , treatment with fosinopril had a significant effect on urinary albumin excretion . In addition , fosinopril treatment was associated with a trend in reducing cardiovascular events . Treatment with pravastatin did not result in a significant reduction in urinary albumin excretion or cardiovascular events

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Analysis of Efficacy and Safety in Patients Aged 65–75 Years at Randomization

OBJECTIVE —Rates of cardiovascular disease are highest in the elderly . Lipid-lowering statin therapy reduces the proportional risk as effectively in older patients as in younger individuals ; however , limited data are available for elderly patients with type 2 diabetes . We conducted a post hoc analysis to compare the efficacy and safety of atorvastatin among 1,129 patients aged 65–75 years at r and omization with 1,709 younger patients in the Collaborative Atorvastatin Diabetes Study ( CARDS ) . RESEARCH DESIGN AND METHODS —CARDS was a r and omized placebo-controlled trial of 10 mg/day atorvastatin for primary prevention of cardiovascular disease in patients aged 40–75 years with LDL cholesterol concentrations ≤4.14 mmol/l followed for a median of 3.9 years . The primary end point was time to first occurrence of acute coronary heart disease events , coronary revascularizations , or stroke . RESULTS —Atorvastatin treatment result ed in a 38 % reduction in relative risk ( [ 95 % CI −58 to −8 ] , P = 0.017 ) of first major cardiovascular events in older patients and a 37 % reduction ( [ −57 to −7 ] , P = 0.019 ) in younger patients . Corresponding absolute risk reductions were 3.9 and 2.7 % , respectively ( difference 1.2 % [ 95 % CI −2.8 to 5.3 ] , P = 0.546 ) ; numbers needed to treat for 4 years to avoid one event were 21 and 33 , respectively . All-cause mortality was reduced nonsignificantly by 22 % ( [ −49 to 18 ] , P = 0.245 ) and 37 % ( [ −64 to 9 ] , P = 0.98 ) , respectively . The overall safety profile of atorvastatin was similar between age-groups . CONCLUSIONS —Absolute and relative benefits of statin therapy in older patients with type 2 diabetes are substantial , and all patients warrant treatment unless specifically contraindicated

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Behavioral implications of lowering cholesterol levels: a double-blind pilot study.

The treatment of hypercholesterolemia may be associated with greater noncardiac mortality . This current pilot study sought to determine which behaviors , if any , are associated with decreases in cholesterol level . Twelve subjects received one of two cholesterol-reducing drugs or placebo . Cholesterol and behavioral ratings were measured at baseline , 4 , and 52 weeks with st and ardized scales . Cholesterol levels markedly declined with concomitant significant increases in impulsivity ratings at 4 weeks . At 52 weeks , the increase in impulsivity ratings was no longer apparent , but depression ratings showed a significant improvement . This pilot study , although limited in size , raises the possibility that cholesterol-lowering drugs are associated with mild , time-limited increases in impulsivity and with mild , time-delayed improvements in depression ratings

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Effect of Intensive Versus Standard Lipid-Lowering Treatment With Atorvastatin on the Progression of Calcified Coronary Atherosclerosis Over 12 Months: A Multicenter, Randomized, Double-Blind Trial

Background — Recent clinical trials have suggested that intensive versus st and ard lipid-lowering therapy provides for additional benefit . Electron-beam computed tomography provides the opportunity to quantify the progression of coronary artery calcification ( CAC ) in serial measurements . Methods and Results — In a multicenter , r and omized , double-blind trial , 471 patients ( age 61±8 years ) who had no history of coronary artery disease and no evidence of high- grade coronary stenoses ( > 50 % diameter reduction ) were r and omized if they had ≥2 cardiovascular risk factors and moderate calcified coronary atherosclerosis as evidence d by a CAC score ≥30 . Patients were assigned to receive 80 mg or 10 mg of atorvastatin per day over 12 months . Progression of CAC volume scores could be analyzed in 366 patients . After pretreatment with 10 mg of atorvastatin for 4 weeks , 12 months of study medication reduced LDL cholesterol from 106±22 to 87±33 mg/dL in the group r and omized to receive 80 mg of atorvastatin ( P<0.001 ) , whereas levels remained stable in the group r and omized to receive 10 mg ( 108±23 at baseline , 109±28 mg/dL at the end of the study , P = NS ) . The mean progression of CAC volume scores , corrected for the baseline CAC volume score , was 27 % ( 95 % CI 20.8 % to 33.1 % ) in the 80-mg atorvastatin group and 25 % ( 95 % CI 19.1 % to 30.8 % ) in the 10-mg atorvastatin group ( P=0.65 ) . CAC progression showed no relationship with on-treatment LDL cholesterol levels . Conclusions — We did not observe a relationship between on-treatment LDL cholesterol levels and the progression of calcified coronary atherosclerosis . Over a period of 12 months , intensive atorvastatin therapy was unable to attenuate CAC progression compared with st and ard atorvastatin therapy . The possibility remains that the time window was too short to demonstrate an effect

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Measurement of C-reactive protein for the targeting of statin therapy in the primary prevention of acute coronary events.

BACKGROUND Elevated levels of C-reactive protein , even in the absence of hyperlipidemia , are associated with an increased risk of coronary events . Statin therapy reduces the level of C-reactive protein independently of its effect on lipid levels . We hypothesized that statins might prevent coronary events in persons with elevated C-reactive protein levels who did not have overt hyperlipidemia . METHODS The level of C-reactive protein was measured at base line and after one year in 5742 participants in a five-year r and omized trial of lovastatin for the primary prevention of acute coronary events . RESULTS The rates of coronary events increased significantly with increases in the base-line levels of C-reactive protein . Lovastatin therapy reduced the C-reactive protein level by 14.8 percent ( P<0.001 ) , an effect not explained by lovastatin-induced changes in the lipid profile . As expected , lovastatin was effective in preventing coronary events in participants whose base-line ratio of total cholesterol to high-density lipoprotein ( HDL ) cholesterol was higher than the median ratio , regardless of the level of C-reactive protein ( number needed to treat for five years to prevent 1 event , 47 ; P=0.005 ) . However , lovastatin was also effective among those with a ratio of total to HDL cholesterol that was lower than the median and a C-reactive protein level higher than the median ( number needed to treat , 43 ; P=0.02 ) . In contrast , lovastatin was ineffective among participants with a ratio of total to HDL cholesterol and a C-reactive protein level that were both lower than the median ( number needed to treat , 983 ; P=0.80 ) . CONCLUSIONS Statin therapy may be effective in the primary prevention of coronary events among subjects with relatively low lipid levels but with elevated levels of C-reactive protein

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

The effect of statin therapy on endothelial function in type 2 diabetes without manifest cardiovascular disease.

OBJECTIVE Cardiovascular disease ( CVD ) is the most important cause of mortality in patients with type 2 diabetes and is preceded by endothelial dysfunction . Flow-mediated dilation ( FMD ) is a noninvasive technique for measuring endothelial dysfunction . We aim ed to determine the effect of long-term statin therapy versus placebo on FMD in patients with type 2 diabetes without manifest CVD . RESEARCH DESIGN AND METHODS A r and omized , placebo-controlled , double-blind trial was performed with 250 type 2 diabetic patients . Patients were given 0.4 mg cerivastatin or placebo daily . In August 2001 , when cerivastatin was withdrawn from the market , the 0.4 mg cerivastatin was replaced by 20 mg simvastatin , without deblinding the study . The primary end point was the change in FMD , measured by B-mode ultrasound , after 2 years . RESULTS Determinants of baseline FMD were diabetes duration , common carotid intima-media thickness , and brachial artery diameter . FMD at baseline was 1.51 % in the placebo group and 1.66 % in the statin group and did not change significantly after 2 years . CONCLUSIONS The 2-year statin therapy had no effect on FMD in type 2 diabetes . Statin-induced improvement of cardiovascular risk in patients with type 2 diabetes may be mediated through mechanisms other than increased nitric oxide availability

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Effect of intensive lipid-lowering therapy with rosuvastatin on progression of carotid intima-media thickness in Japanese patients: Justification for Atherosclerosis Regression Treatment (JART) study.

BACKGROUND A recent trial in Western countries has shown that rosuvastatin slows progression of carotid intima-media thickness ( IMT ) in patients with modest carotid IMT thickening and elevated levels of low-density lipoprotein cholesterol ( LDL-C ) . We conducted a prospect i ve , r and omized , open-label , blinded-endpoint trial to determine whether rosuvastatin is more effective than pravastatin in slowing progression of carotid IMT in Japanese patients . METHODS AND RESULTS Adult patients with hypercholesterolemia who had a maximum IMT ≥1.1 mm were r and omly assigned to receive rosuvastatin or pravastatin . The primary endpoint was the percent change in the mean-IMT , which was measured by a single observer who was blinded to the treatment assignments . The trial was stopped on April 2011 according to the recommendation by the data and safety monitoring committee . A total of 348 patients ( 173 rosuvastatin ; 175 pravastatin ) were enrolled and 314 ( 159 rosuvastatin ; 155 pravastatin ) were included in the primary analysis . Mean ( SD ) percentage changes in the mean-IMT at 12 months were 1.91 % ( 10.9 ) in the rosuvastatin group and 5.8 % ( 12.0 ) in the pravastatin group , with a difference of 3.89 % ( 11.5 ) between the groups ( P=0.004 ) . At 12 months , 85 patients ( 59.4 % ) in the rosuvastatin group achieved a LDL-C/high-density lipoprotein cholesterol ratio ≤1.5 compared with 24 patients ( 16.4 % ) in the pravastatin group ( P<0.0001 ) . CONCLUSIONS Rosuvastatin significantly slowed progression of carotid IMT at 12 months compared with pravastatin

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Relation of baseline high-sensitivity C-reactive protein level to cardiovascular outcomes with rosuvastatin in the Justification for Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER).

In the Justification for Use of statins in Prevention : an Intervention Trial Evaluating Rosuvastatin ( JUPITER ) , r and om allocation of rosuvastatin compared to placebo among primary prevention patients with a low-density lipoprotein cholesterol level of < 130 mg/dl and a high-sensitivity C-reactive protein ( hs-CRP ) level of > or = 2 mg/L result ed in a highly significant 44 % reduction in major vascular events . However , the relation of baseline hs-CRP levels to risk within JUPITER has not previously been described and has been an area of controversy for study interpretation . As reported in the present study for the first time , despite enrolling patients with a constrained range of values , increasing baseline hs-CRP levels within JUPITER were nonetheless associated with increasing vascular risk in analyses treating hs-CRP as a continuous variable , as an ordinal variable , and as a threshold variable . As anticipated , the relative risk reduction associated with rosuvastatin was similar in magnitude across the tertile and threshold levels of entry hs-CRP . In conclusion , as the absolute risk increased with increasing hs-CRP , the absolute risk reduction associated with rosuvastatin within JUPITER was also greatest among those with the greatest entry hs-CRP levels

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Impact of atorvastatin among older and younger patients in the Anglo-Scandinavian Cardiac Outcomes Trial Lipid-Lowering Arm

Objective Older patients experience higher rates of cardiovascular disease than younger patients , but may be undertreated with statins due to doubts about efficacy and safety . The Lipid-Lowering Arm of the Anglo-Sc and inavian Cardiac Outcomes Trial allowed an evaluation of the efficacy and safety of atorvastatin among older ( ≥65 years ) and younger ( < 65 years ) patients with hypertension . Methods A total of 10 305 patients with hypertension , at least three other cardiovascular risk factors , total cholesterol concentrations of 251 mg/dl or less , and no known coronary heart disease ( CHD ) were r and omized to receive atorvastatin 10 mg or placebo . The primary endpoint was a composite of nonfatal myocardial infa rct ion and fatal CHD . Results There were 4445 patients in the older group ( mean 71 years ) and 5860 patients ( mean 57 years ) in the younger group . Among those taking placebo , the older group experienced a higher rate of primary endpoints than the younger group ( 11.7 vs. 7.6 events per 1000 patient years , respectively ) . After a median follow-up of 3.3 years , the primary endpoint was reduced by a similar proportion in both older and younger patients ( 37 vs. 33 % , respectively ) . Although older patients reported more serious adverse events than younger patients , there were no significant differences between atorvastatin and placebo within each age group . Conclusion Atorvastatin reduced the risk of major cardiovascular events to a similar relative extent in both older and younger patients with treated hypertension . However , given that event rates were higher in older patients , the absolute benefits of atorvastatin were greater for older than younger patients

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Semi-parametric risk prediction models for recurrent cardiovascular events in the LIPID study

Background Traditional methods for analyzing clinical and epidemiological cohort study data have been focused on the first occurrence of a health outcome . However , in many situations , recurrent event data are frequently observed . It is inefficient to use methods for the analysis of first events to analyse recurrent event data . Methods We applied several semi-parametric proportional hazards models to analyze the risk of recurrent myocardial infa rct ion ( MI ) events based on data from a very large r and omized placebo-controlled trial of cholesterol-lowering drug . The backward selection procedure was used to select the significant risk factors in a model . The best fitting model was selected using the log-likelihood ratio test , Akaike Information and Bayesian Information Criteria . Results A total of 8557 persons were included in the LIPID study . Risk factors such as age , smoking status , total cholesterol and high density lipoprotein cholesterol levels , qualifying event for the acute coronary syndrome , revascularization , history of stroke or diabetes , angina grade and treatment with pravastatin were significant for development of both first and subsequent MI events . No significant difference was found for the effects of these risk factors between the first and subsequent MI events . The significant risk factors selected in this study were the same as those selected by the parametric conditional frailty model . Estimates of the relative risks and 95 % confidence intervals were also similar between these two methods . Conclusions Our study shows the usefulness and convenience of the semi-parametric proportional hazards models for the analysis of recurrent event data , especially in estimation of regression coefficients and cumulative risks

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial—Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial

BACKGROUND The lowering of cholesterol concentrations in individuals at high risk of cardiovascular disease improves outcome . No study , however , has assessed benefits of cholesterol lowering in the primary prevention of coronary heart disease ( CHD ) in hypertensive patients who are not conventionally deemed dyslipidaemic . METHODS Of 19342 hypertensive patients ( aged 40 - 79 years with at least three other cardiovascular risk factors ) r and omised to one of two antihypertensive regimens in the Anglo-Sc and inavian Cardiac Outcomes Trial , 10305 with non-fasting total cholesterol concentrations 6.5 mmol/L or less were r and omly assigned additional atorvastatin 10 mg or placebo . These patients formed the lipid-lowering arm of the study . We planned follow-up for an average of 5 years , the primary endpoint being non-fatal myocardial infa rct ion and fatal CHD . Data were analysed by intention to treat . FINDINGS Treatment was stopped after a median follow-up of 3.3 years . By that time , 100 primary events had occurred in the atorvastatin group compared with 154 events in the placebo group ( hazard ratio 0.64 [ 95 % CI 0.50 - 0.83 ] , p=0.0005 ) . This benefit emerged in the first year of follow-up . There was no significant heterogeneity among prespecified subgroups . Fatal and non-fatal stroke ( 89 atorvastatin vs 121 placebo , 0.73 [ 0.56 - 0.96 ] , p=0.024 ) , total cardiovascular events ( 389 vs 486 , 0.79 [ 0.69 - 0.90 ] , p=0.0005 ) , and total coronary events ( 178 vs 247 , 0.71 [ 0.59 - 0.86 ] , p=0.0005 ) were also significantly lowered . There were 185 deaths in the atorvastatin group and 212 in the placebo group ( 0.87 [ 0.71 - 1.06 ] , p=0.16 ) . Atorvastatin lowered total serum cholesterol by about 1.3 mmol/L compared with placebo at 12 months , and by 1.1 mmol/L after 3 years of follow-up . INTERPRETATION The reductions in major cardiovascular events with atorvastatin are large , given the short follow-up time . These findings may have implication s for future lipid-lowering guidelines

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

A double-blind trial on the effects of atorvastatin on glycemic control in Japanese diabetic patients with hypercholesterolemia.

A double-blind , placebo-controlled , parallel-group study was performed to determine whether atorvastatin , a new HMG-CoA reductase inhibitor , could effectively and safely reduce plasma LDL-cholesterol concentrations in Japanese patients with type-2 diabetes without influencing glycemic control . The subjects were patients with hypercholesterolemia ( serum cholesterol concentration > or = 5.7 mmol/l ( 220 mg/dl ) ) and stable glycemic control . The fasting concentrations of hemoglobin A(1C ) ( HbA(1C ) ) , fructosamine , and 1,5-anhydroglucitol ( 1,5-AG ) were measured as indices of glycemic control . Plasma lipid concentrations and the safety of the drug were also examined . Forty eligible patients in two groups of 20 each were administered atorvastatin ( 10 mg/day ) or placebo . Neither atorvastatin nor placebo caused a significant change in HbA(1C ) , fructosamine , or 1,5-AG concentrations . Atorvastatin significantly reduced total cholesterol and LDL-cholesterol concentrations from baseline by 29.7 % ( p<0.0001 ) and 41.6 % ( p<0.0001 ) , respectively . The incidence of clinical adverse events and that of abnormal changes in laboratory test values did not differ between the two groups . In this trial , atorvastatin effectively and safely reduced LDL-cholesterol concentrations in diabetic patients with hypercholesterolemia without influencing glycemic control . These findings are clinical ly important because there are many diabetic patients with hypercholesterolemia and such patients have a high risk of developing arteriosclerotic disease

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis: the METEOR Trial.

CONTEXT Atherosclerosis is often advanced before symptoms appear and it is not clear whether treatment is beneficial in middle-aged individuals with a low Framingham risk score ( FRS ) and mild to moderate sub clinical atherosclerosis . OBJECTIVE To assess whether statin therapy could slow progression and /or cause regression of carotid intima-media thickness ( CIMT ) over 2 years . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , placebo-controlled study ( Measuring Effects on Intima-Media Thickness : an Evaluation of Rosuvastatin [ METEOR ] ) of 984 individuals , with either age ( mean , 57 years ) as the only coronary heart disease risk factor or a 10-year FRS of less than 10 % , modest CIMT thickening ( 1.2-<3.5 mm ) , and elevated LDL cholesterol ( mean , 154 mg/dL ) ; conducted at 61 primary care centers in the United States and Europe between August 2002 and May 2006 . INTERVENTION Participants received either a 40-mg dose of rosuvastatin or placebo . MAIN OUTCOME MEASURES Rate of change in maximum CIMT ( assessed with B-mode ultrasound ) for 12 carotid sites ; changes in maximum CIMT of the common carotid artery , carotid bulb , and internal carotid artery sites and in mean CIMT of the common carotid artery sites . CIMT regression was assessed in the rosuvastatin group only . RESULTS Among participants in the rosuvastatin group , the mean ( SD ) baseline LDL cholesterol level of 155 ( 24.1 ) mg/dL declined to 78 ( 27.5 ) mg/dL , a mean reduction of 49 % ( P<.001 vs placebo group ) . The change in maximum CIMT for the 12 carotid sites was -0.0014 ( 95 % CI , -0.0041 to 0.0014 ) mm/y for the rosuvastatin group vs 0.0131 ( 95 % CI , 0.0087 - 0.0174 ) mm/y for the placebo group ( P<.001 ) . The change in maximum CIMT for the rosuvastatin group was -0.0038 ( 95 % CI , -0.0064 to -0.0013 ) mm/y for the common carotid artery sites ( P<.001 ) , -0.0040 ( 95 % CI , -0.0090 to 0.0010 ) mm/y for the carotid bulb sites ( P<.001 ) , and 0.0039 ( 95 % CI , -0.0009 to 0.0088 ) mm/y for the internal carotid artery sites ( P = .02 ) . The change in mean CIMT for the rosuvastatin group for the common carotid artery sites was 0.0004 ( 95 % CI , -0.0011 to 0.0019 ) mm/y ( P<.001 ) . All P values are vs placebo group . Overall , rosuvastatin was well tolerated with infrequent serious adverse cardiovascular events ( 6 participants [ 0.86 % ] had 8 events [ 1.1 % ] over 2 years ) . CONCLUSIONS In middle-aged adults with an FRS of less than 10 % and evidence of sub clinical atherosclerosis , rosuvastatin result ed in statistically significant reductions in the rate of progression of maximum CIMT over 2 years vs placebo . Rosuvastatin did not induce disease regression . Larger , longer-term trials are needed to determine the clinical implication s of these findings . TRIAL REGISTRATION clinical trials.gov Identifier :

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Cholesterol Reduction With Atorvastatin Improves Walking Distance in Patients With Peripheral Arterial Disease

Background —Cholesterol modification reduces cardiovascular events in patients with atherosclerosis , including those with peripheral arterial disease . The purpose of this study was to determine whether cholesterol lowering with atorvastatin improves walking performance in patients with intermittent claudication . Methods and Results —This r and omized , double-blind , parallel- design study included 354 persons with claudication attributable to peripheral arterial disease . Patients were treated with placebo , atorvastatin ( 10 mg per day ) , or atorvastatin ( 80 mg per day ) for 12 months . The outcome measures included change in treadmill exercise time and patient-reported measures of physical activity and quality of life based on question naires . Maximal walking time after 12 months of treatment with atorvastatin did not change significantly . However , there was improvement in pain-free walking time after 12 months of treatment for the 80-mg ( P = 0.025 ) group compared with placebo . A physical activity question naire demonstrated improvement in ambulatory ability for the 10- and 80-mg groups ( P = 0.011 ) , whereas 2 quality of life instruments , the Walking Impairment Question naire and Short Form 36 Question naire , did not show significant change . Conclusions —Atorvastatin improves pain-free walking distance and community-based physical activity in patients with intermittent claudication . When treated with atorvastatin , patients with peripheral arterial disease may experience improvement in symptoms to complement the anticipated reduction in cardiovascular events reported in other studies of statins

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Effects of pravastatin on left ventricular mass in patients with hyperlipidemia and essential hypertension.

Left ventricular ( LV ) mass is a powerful predictor for future cardiovascular events . Epidemiologic studies have shown that hyperlipidemia is associated with higher LV mass . The effects of statin therapy for hyperlipidemia on LV mass have not been studied . To determine the effects of statin therapy on LV mass , we prospect ively studied 3 groups of age and body surface area-matched patients : group 1 ( n = 20 ) , patients with systemic hypertension and hyperlipidemia treated with pravastatin plus anti-hypertensive drugs ; group 2 ( n = 20 ) , patients with hypertension and hyperlipidemia treated with hypertensive agents and diet control alone ; and group 3 ( n = 20 ) , hypertensive patients with normolipidemia treated with antihypertensive agents . A group of controls without hypertension or hyperlipidemia was used for comparison . Echocardiograms were recorded at baseline and after 6-month therapy . All hypertensive groups showed significant decreases in LV mass index after treatment . Group 1 had the greatest decrease in LV mass and it was significantly higher than in groups 2 and 3 . Multivariate analysis revealed that regression of LV mass was significantly correlated only with the use of statins and sex ( p = 0.005 and 0.01 , respectively , R(2 ) = 0.47 ) . Linear regression analysis in group 1 showed a significant correlation between changes in arterial compliance and LV mass regression ( r = 0.57 , p = 0.01 ) . Thus , the addition of a statin may have an additional effect on reducing LV mass , independent of lipid-lowering effects

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Effects of atorvastatin on bone in postmenopausal women with dyslipidemia: a double-blind, placebo-controlled, dose-ranging trial.

CONTEXT In pre clinical models , inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A reductase have been shown to positively affect bone remodeling balance . Observational studies and secondary analyses from lipid-lowering trials have yielded inconsistent results regarding the effect of these agents on bone mineral density and fracture risk . OBJECTIVE Our objective was to determine whether clinical ly significant skeletal benefits result from hydroxymethylglutaryl-coenzyme A reductase inhibition in postmenopausal women . DESIGN AND SETTING We conducted a prospect i ve , r and omized , double-blind , placebo-controlled , dose-ranging comparative clinical trial at 62 sites in the United States . PARTICIPANTS Participants included 626 postmenopausal women with low-density lipoprotein cholesterol levels of at least 130 mg/dl ( 3.4 mmol/liter ) and less than 190 mg/dl ( 4.9 mmol/liter ) , and lumbar ( L1-L4 ) spine bone mineral density T-score between 0.0 and -2.5 . INTERVENTION Once-daily placebo or 10 , 20 , 40 , or 80 mg atorvastatin was administered . MAIN OUTCOME MEASURES We assessed percent change from baseline in lumbar ( L1-L4 ) spine bone mineral density with each dose of atorvastatin compared with placebo . RESULTS At 52 wk , there was no significant difference between each atorvastatin and placebo group or change from baseline at any tested dose of atorvastatin or placebo in lumbar ( L1-L4 ) spine bone mineral density . Nor did atorvastatin produce a significant change in bone mineral density at any other site . Changes in biochemical markers of bone turnover did not differ significantly between each atorvastatin and placebo group . All doses of atorvastatin were generally well tolerated , with similar incidences of adverse events across all dose groups and placebo . CONCLUSIONS Clinical ly relevant doses of atorvastatin that lower lipid levels had no effect on bone mineral density or biochemical indices of bone metabolism in this study , suggesting that such oral agents are not useful in the prevention or treatment of osteoporosis

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Randomized, double-blind, placebo-controlled comparison of the action of orlistat, fluvastatin, or both an anthropometric measurements, blood pressure, and lipid profile in obese patients with hypercholesterolemia prescribed a standardized diet.

OBJECTIVE The aim of this study was to assess obese patients with hypercholesterolemia whom were prescribed a st and ardized diet , comparing the action of orlistat , fluvastatin , orlistat with fluvastatin , and placebo on anthropometric measurements , blood pressure ( BP ) , and lipid profile . METHODS This was a 1-year , r and omized , double-blind , placebo-controlled trial . The patients were prescribed a controlled-energy diet and were r and omly allocated to receive placebo , orlistat 120 mg TID ( O group ) , fluvastatin 80 mg/d ( F group ) , or olistat 120 mg TID with fluvastatin 80 mg/d ( OF group ) . Clinical measurements ( body weight , body mass index [ BMI ] , waist circumference , and BP ) and lipid profile assessment ( total cholesterol [ TC ] , low-density lipoprotein cholesterol [ LDL-C ] , high-density lipoprotein cholesterol [ HDL-C ] , and triglycerides [ TGs ] ) were performed at baseline and after 6 months and 1 year of treatment . RESULTS The study included 99 obese patients with hypercholesterolemia ( 48 men and 51 women ; mean [ SD ] age , 51 [ 9 ] years ) . There were no significant differences between groups in baseline demographic , BP , or plasma lipid values . Three patients dropped out ( 2 women in the O group and 1 man in the OF group ) due to adverse events related to orlistat treatment , including gastrointestinal events ( oily spotting and fecal urgency ) . Ninety-six patients completed the study . There were significant differences from baseline ( mean [ SD ] ) in BMI , waist circumference reduction ( WCR ) , and body weight loss ( BWL ) at 6 months in the OF group ( 29.9 [ 1.1 ] kg/m(2 ) , 2.7 [ 0.8 ] cm , and 7.4 [ 0.9 ] kg , respectively ; all P < 0.05 ) , and BMI , WCR , and BWL at 1 year in the O group ( 29.0 [ 1.0 ] kg/m(2 ) , 3.0 [ 1.0 ] cm , and 8.6 [ 1.0 ] kg , respectively ; all P < 0.02 ) , the F group ( 29.3 [ 1.6 ] kg/m(2 ) , 2.4 [ 1.0 ] cm , and 8/0 [ 1.0 ] kg , respectively ; all P < 0.05 ) , and the OF group ( 28.4 [ 0.6 ] kg/m(2 ) , 4.0 [ 0.6 ] cm , and 11.4 [ 1.0 ] kg , respectively ; all P < 0.01 ) . Significant reductions from baseline in systolic and diastolic BP were observed at 1 year in the O and F groups ( all P < 0.05 ) and the OF group ( both P < 0.01 ) . At 6 months , there were significant reductions from baseline in TC and LDL-C in the F group ( both P < 0.05 ) and in TC , LDL-C , and TGs in the OF group ( P < 0.02 , P < 0.02 , and P < 0.05 , respectively ) , as well as a significant increase in HDL-C in the OF group ( P < 0.02 ) . At 1 year , there were significant reduction from baseline in TC in the O , F , and OF groups ( P < 0.05 and P < 0.01 , respectively ) , LDL-C ( P < 0.05 , P < 0.02 , and P < 0.01 , respectively ) , and TGs ( P < 0.02 , P < 0.05 , and P < 0.02 , respectively ) . Also at 1 year , HDL-C was significantly higher than baseline in the F and OF groups ( P < 0.02 and P < 0.01 , respectively ) . CONCLUSION Improvements in clinical and lipid-profile parameters were found at 1 year with all 3 treatments

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Efficacy and Safety of Atorvastatin in the Prevention of Cardiovascular End Points in Subjects With Type 2 Diabetes

OBJECTIVE —Cardiovascular disease ( CVD ) risk is increased in type 2 diabetes . The purpose of this study was to assess the effect of 10 mg of atorvastatin versus placebo on CVD prevention in subjects with type 2 diabetes and LDL cholesterol levels below contemporary guideline targets . RESEARCH DESIGN AND METHODS —Subjects were r and omly assigned to receive 10 mg of atorvastatin or placebo in a 4-year , double-blind , parallel-group study . The composite primary end point comprised cardiovascular death , nonfatal myocardial infa rct ion , nonfatal stroke , recanalization , coronary artery bypass surgery , resuscitated cardiac arrest , and worsening or unstable angina requiring hospitalization . RESULTS —A total of 2,410 subjects with type 2 diabetes were r and omized . Mean LDL cholesterol reduction in the atorvastatin group over 4 years was 29 % versus placebo ( P < 0.0001 ) . When we compared atorvastatin versus placebo , composite primary end point rates were 13.7 and 15.0 % , respectively ( hazard ratio 0.90 [ 95 % CI 0.73–1.12 ] ) . In the subset of 1,905 subjects without prior myocardial infa rct ion or interventional procedure , 10.4 % of atorvastatin- and 10.8 % of placebo-treated subjects experienced a primary end point ( 0.97 [ 0.74–1.28 ] ) . In the 505 subjects with prior myocardial infa rct ion or interventional procedure , 26.2 % of atorvastatin- and 30.8 % of placebo-treated subjects experienced a primary end point ( 0.82 [ 0.59–1.15 ] ) . Relative risk reductions in fatal and nonfatal myocardial infa rct ion were 27 % overall ( P = 0.10 ) and 19 % ( P = 0.41 ) and 36 % ( P = 0.11 ) for subjects without and with prior myocardial infa rct ion or interventional procedure , respectively . CONCLUSIONS —Composite end point reductions were not statistically significant . This result may relate to the overall study design , the types of subjects recruited , the nature of the primary end point , and the protocol changes required because of changing treatment guidelines . For these reasons , the results of the Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in Non-Insulin-Dependent Diabetes Mellitus ( ASPEN ) did not confirm the benefit of therapy but do not detract from the imperative that the majority of diabetic patients are at risk of coronary heart disease and deserve LDL cholesterol lowering to the currently recommended targets

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Effect of lovastatin on early carotid atherosclerosis and cardiovascular events. Asymptomatic Carotid Artery Progression Study (ACAPS) Research Group.

BACKGROUND HMG CoA reductase inhibitors ( or statins ) , a new class of lipid-lowering compounds , have raised expectations for more widespread use than that of the older lipid-lowering drugs . Not only are they more effective in lowering LDL cholesterol , but they are better tolerated as well . No data exist concerning the effect of statins on early carotid atherosclerosis and clinical events in men and women who have moderately elevated LDL cholesterol levels but are free of symptomatic cardiovascular disease . METHODS AND RESULTS Lovastatin ( 20 to 40 mg/d ) or its placebo was evaluated in a double-blind , r and omized clinical trial with factorial design along with warfarin ( 1 mg/d ) or its placebo . This report is limited to the lovastatin component of the trial . Daily aspirin ( 81 mg/d ) was recommended for everyone . Enrollment included 919 asymptomatic men and women , 40 to 79 years old , with early carotid atherosclerosis as defined by B-mode ultrasonography and LDL cholesterol between the 60th and 90th percentiles . The 3-year change in mean maximum intimal-medial thickness ( IMT ) in 12 walls of the carotid arteries was the primary outcome ; change in single maximum IMT and incidence of major cardiovascular events were secondary outcomes . LDL cholesterol fell 28 % , from 156.6 mg/dL at baseline to 113.1 mg/dL at 6 months ( P < .0001 ) , in the lovastatin groups and was largely unchanged in the lovastatin-placebo groups . Among participants not on warfarin , regression of the mean maximum IMT was seen after 12 months in the lovastatin group compared with the placebo group ; the 3-year difference was statistically significant ( P = .001 ) . A larger favorable effect of lovastatin was observed for the change in single maximum IMT but was not statistically significant ( P = .12 ) . Five lovastatin-treated participants suffered major cardiovascular events -- coronary heart disease mortality , nonfatal myocardial infa rct ion , or stroke -- versus 14 in the lovastatin-placebo groups ( P = .04 ) . One lovastatin-treated participant died , compared with eight on lovastatin-placebo ( P = .02 ) . CONCLUSIONS In men and women with moderately elevated LDL cholesterol , lovastatin reverses progression of IMT in the carotid arteries and appears to reduce the risk of major cardiovascular events and mortality . Results from ongoing large-scale clinical trials may further establish the clinical benefit of statins

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Pravastatin therapy in hyperlipidemia: effects on thrombus formation and the systemic hemostatic profile.

OBJECTIVES The study sought to determine the effects of lipid-lowering with pravastatin on the systemic fibrinolytic profile and on thrombus formation under dynamic flow conditions . BACKGROUND Lowering cholesterol ( C ) decreases clinical events in coronary artery disease ( CAD ) patients , but an analysis of the effects of lipid-lowering on the entire hemostatic and thrombotic profile has not been conducted . METHODS We prospect ively studied 93 stable patients with untreated low-density lipoprotein cholesterol ( LDL-C ) > 145 mg/dl . The CAD patients received pravastatin , and non-CAD patients were r and omized to pravastatin versus placebo ( double-blind ) . Thrombus formation upon an injured vascular surface was assessed in a sub study of 40 patients with a previously vali date d ex vivo perfusion chamber system . Systemic hemostatic markers and thrombus formation were evaluated at baseline , three and six months . RESULTS Placebo produced no changes in either the lipid profile , any of the hemostatic markers , or the ex vivo thrombus formation . Both pravastatin groups ( CAD and non-CAD ) showed decreased LDL-C by 30 % within 6 weeks ( 188 to 126 mg/dl , p < 0.001 vs. baseline ) , and decreased plasminogen activator inhibitor-1 at 3- and 6-month follow-up compared to baseline ( 15 % to 18 % decrease at 3 months and 21 % to 23 % at 6 months ) . For the tissue plasminogen activator antigen , CAD and non-CAD groups showed significant decreases at 6 months compared to baseline ( 10 % and 13 % , respectively ) . No significant changes were observed with treatment in d-dimer , fibrinopeptide A , prothrombin fragment F1.2 , factor VIIa , von Willebr and factor , or C-reactive protein . Fibrinogen levels were significantly increased at 6 months compared to baseline , though still below the upper normal limit . In the perfusion chamber sub study , there was a decrease in thrombus area in non-CAD patients treated with pravastatin at both 3 and 6 months compared to baseline ( by 21 % and 34 % , respectively ) . The CAD patients showed decreases in thrombus formation by 13 % at 3 months , and by 16 % at 6 months . The change in LDL-C- correlated modestly with the change in thrombus formation ( r = 0.49 ; p < 0.01 ) . CONCLUSIONS Pravastatin therapy significantly decreased thrombus formation and improved the fibrinolytic profile in patients with and without CAD . These early effects may , in part , explain the benefit rendered in primary and secondary prevention of CAD

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Serum cholesterol concentration and coronary heart disease in population with low cholesterol concentrations.

OBJECTIVE --To examine the relation between serum cholesterol concentration and mortality ( from coronary heart disease and from other causes ) below the range of cholesterol values generally seen in Western population s. DESIGN -- Prospect i ve observational study based on 8 - 13 years of follow up of subjects in a population with low cholesterol concentrations . SETTING --Urban Shanghai , China . SUBJECTS--9021 Chinese men and women aged 35 - 64 at baseline . MAIN OUTCOME MEASURE -- Death from coronary heart disease and other causes . RESULTS --The average serum cholesterol concentration was 4.2 mmol/l at baseline examination , and only 43 ( 7 % ) of the deaths that occurred during 8 - 13 years of follow up were attributed to coronary heart disease . There was a strongly positive , and apparently independent , relation between serum cholesterol concentration and death from coronary heart disease ( z = 3.47 , p less than 0.001 ) , and within the range of usual serum cholesterol concentration studied ( 3.8 - 4.7 mmol/l ) there was no evidence of any threshold . After appropriate adjustment for the regression dilution bias , a 4 ( SD 1)% difference in usual cholesterol concentration was associated with a 21 ( SD 6)% ( 95 % confidence interval 9 % to 35 % ) difference in mortality from coronary heart disease . There was no significant relation between serum cholesterol concentration and death from stroke or all types of cancer . The 79 deaths due to liver cancer or other chronic liver disease were inversely related to cholesterol concentration at baseline . CONCLUSION --Blood cholesterol concentration was directly related to mortality from coronary heart disease even in those with what was , by Western st and ards , a " low " cholesterol concentration . There was no good evidence of an adverse effect of cholesterol on other causes of death

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Short- and long-term effect of simvastatin therapy on the heterogeneity of cardiac repolarization in diabetic patients.

The interlead variability of QT interval in the 12-lead electrocardiogram , QT dispersion ( QTd ) , has been shown to reflect dispersion of ventricular refractoriness and may provide a measure of arrhythmogenic potential in diabetic patients . QTd and heart rate corrected QTd ( QTcd ) were also proposed to be accurate predictors of cardiac death in patients with diabetes . In recent years , experimental and clinical evidence demonstrates that statins exert antiarrhythmic properties . Therefore , in the present study , we have examined whether simvastatin treatment has any effect on the QTd and QTcd in patients with diabetes mellitus . Sixty type 2 diabetic patients without known coronary artery disease and low-density lipoprotein cholesterol > 100mg/dl and 30 age and sex-matched non-diabetic controls were included in a prospect i ve study . Out of 60 diabetic patients , 30 were treated with simvastatin 40 mg/day for 1 year and the remaining 30 subjects were served as diabetic controls . No lipid lowering therapy was administered to the diabetic and the non-diabetic controls . QTd and QTcd of treated diabetics and the non-diabetic controls were measured at baseline , 6 , 12 weeks and at 1 year . QTd and QTcd of the diabetic controls were obtained at baseline , 6 and 12 weeks . Both QTd and QTcd were significantly greater in patients with the diabetes than in the non-diabetic controls at baseline ( 52+/-13 ms vs. 41+/-12 ms , p<0.001 and 62+/-17 ms vs. 42+/-11 ms , p<0.001 , respectively ) . Simvastatin therapy significantly decreased both QTd and QTcd at the end of first year compared to baseline ( 51+/-15 ms vs. 33+/-11 ms , p<0.001 and 60+/-18 ms vs. 38+/-12 ms , p<0.001 , respectively ) . No significant change were found in QTd and QTcd in the non-diabetic ( p=0.29 and p=0.87 by ANOVA , respectively ) and in the diabetic controls ( p=0.72 and p=0.57 , by ANOVA , respectively ) . This study suggests for the first time that simvastatin treatment in diabetic patients with hyperlipidemia is associated with an improvement in the heterogeneity of cardiac repolarization . This may be one of the mechanisms for the reduction in clinical events reported in the survival studies with statins . Further prospect i ve r and omized studies are warranted to confirm our findings

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Expanded clinical evaluation of lovastatin (EXCEL) study: design and patient characteristics of a double-blind, placebo-controlled study in patients with moderate hypercholesterolemia.

The r and omized , double-blind , placebo-controlled trial described in this report was undertaken to clarify the dose-response relation of lovastatin therapy to lipid-modifying efficacy ( lipid/lipoprotein modification ) and drug-related adverse events in a population with moderately elevated fasting plasma total cholesterol ( 240 to 300 mg/dl ) and low-density lipoprotein cholesterol ( greater than or equal to 160 mg/dl ) . Men or women ( postmenopausal or surgically sterile ) , aged 18 to 70 years , were entered into the trial with minimal exclusion criteria . After 4 to 6 weeks of an American Heart Association phase I diet or a more stringent diet , 8,245 patients from 362 sites were r and omized to 1 of 5 parallel diet and drug treatment groups : placebo ( n = 1,663 ) or lovastatin , 20 mg ( n = 1,642 ) and 40 mg ( n = 1,645 ) with the evening meal , and 20 mg ( n = 1,646 ) or 40 mg twice daily ( n = 1,649 ) . The regimen of diet and lovastatin ( or placebo ) was followed for 48 weeks . The 5 treatment groups were similar at baseline . The total cohort had the following characteristics : 59 % were men ( mean age 56 years ) ; 92 % were white ; 59 % had completed at least 1 year of education beyond high school ; 57 % had a history of cardiovascular and associated disease ; 40 % had a history of hypertension ; and 29 % had coronary artery disease . Health habits were similar among groups , with 18 % of patients reporting cigarette smoking , 14 % reporting that they consume greater than 1 alcoholic beverage daily and 67 % reporting no strenous exercise . Mean lipid/lipoprotein levels were also similar among groups , with the following average levels : total cholesterol ( 258 mg/dl ) , low-density lipoprotein cholesterol ( 180 mg/dl ) , high-density lipoprotein cholesterol ( 45 mg/dl ) and triglycerides ( median = 155 mg/dl ) . The large size of this trial , its placebo-controlled , double-blind design and the similarity of treatment groups at baseline should allow clear documentation of the long-term effects of lovastatin treatment and generalization of the results to a substantial portion of patients who may be c and i date s for lipid-modifying therapy

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Taking simvastatin in the morning compared with in the evening: randomised controlled trial

Statins are widely prescribed for the primary and secondary prevention of coronary artery disease . They act by inhibiting the enzyme HMG CoA reductase , which controls synthesis of cholesterol in the liver . Most manufacturers of statins recommend that they are taken at night , on the basis of physiological studies which show that most cholesterol is synthesis ed when dietary intake is at its lowest.1 One small clinical trial found that taking smaller doses of simvastatin than are used in treatment , in the morning , was less efficient.2 However , a trial using atorvastatin found no significant difference in cholesterol concentrations between patients taking the statin in the morning and those taking it in the evening.3 Doubt has been cast on whether statins need to be taken at night,4 particularly as many patients also receive treatment with other cardioprotective drugs and compliance may be compromised by multiple

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

A Prospective Study of Pravastatin in the Elderly at Risk (PROSPER): Screening Experience and Baseline Characteristics

Background PROSPER was design ed to investigate the benefits of treatment with pravastatin in elderly patients for whom a typical doctor might consider the prescription of statin therapy to be a realistic option . Methods The PROspect i ve Study of Pravastatin in the Elderly at Risk ( PROSPER ) is a r and omised , double blind , placebo-controlled trial to test the hypothesis that treatment with pravastatin ( 40 mg/day ) will reduce the risk of coronary heart disease death , non-fatal myocardial infa rct ion , and fatal or non-fatal stroke in elderly men and women with pre-existing vascular disease or with significant risk of developing this condition . Results In Scotl and , Irel and , and the Netherl and s , 23,770 individuals were screened , and 5,804 subjects ( 2,804 men and 3,000 women ) , aged 70 to 82 years ( average 75 years ) and with baseline cholesterol 4.0–9.0 mmol/l , were r and omised . R and omised subjects had similar distributions with respect to age , blood pressure , and body mass index when compared to the entire group of screenees , but had a higher prevalence of smoking , diabetes , hypertension , and a history of vascular disease . The average total cholesterol level at baseline was 5.4 mmol/l ( men ) and 6.0 mmol/l ( women ) . Conclusions Compared with previous prevention trials of cholesterol-lowering drugs , the PROSPER cohort is significantly older and for the first time includes a majority of women . The study , having achieved its initial goal of recruiting more than 5,500 elderly high-risk men and women , aims to complete all final subject follow-up visits in the first half of 2002 with the main results being available in the fourth quarter of 2002

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Serum cholesterol, haemorrhagic stroke, ischaemic stroke, and myocardial infarction: Korean national health system prospective cohort study

Abstract Objective To investigate risk factors , such as heavy alcohol consumption , that might explain any increased risk of haemorrhagic stroke associated with low blood cholesterol . Design Prospect i ve cohort study . Setting Korea . Participants 787 442 civil servants ( 661 700 men , 125 742 women ) aged 30 - 64 . Main outcome measures Cardiovascular risk factors were assessed at biennial health check . Data on morbidity and mortality were ascertained from 1990 to 2001 using hospital admissions and mortality surveillance systems . Results 6328 cases of ischaemic stroke ( 6021 men , 307 women ) , 3947 cases of haemorrhagic stroke ( 3748 men , 199 women ) , 3170 cases of undefined stroke ( 2902 men , 268 women ) , and 4417 cases of myocardial infa rct ion ( 4305 men , 112 women ) occurred . Ischaemic stroke and myocardial infa rct ion were strongly and positively associated with blood cholesterol ( hazard ratio per 1 mmol/l cholesterol 1.20 ( 95 % confidence 1.16 to 1.24 ) and 1.48 ( 1.43 to 1.53 ) , respectively ) . Haemorrhagic stroke showed an inverse association in fully adjusted models ( 0.91 , 0.87 to 0.95 ) . This inverse association was confined to participants with hypertension . When stratified by concentration of γ glutamyl transferase ( GGT ) , an indicator of alcohol consumption , the association was not seen in participants with low concentrations of GGT , and it was independent of hypertension in those with high concentrations of GGT ( > 80 U/l ) . Conclusion High alcohol consumption may underlie the association between low blood cholesterol and increased risk of haemorrhagic stroke

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Long-term safety and efficacy profile of simvastatin.

Simvastatin , a 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor , has been administered to approximately 2,400 patients with primary hypercholesterolemia with a mean follow-up of 1 year in controlled clinical studies and their open extensions . Approximately 10 % of this population received simvastatin for a period of greater than or equal to 2 years . The population on whom this safety analysis is based had a mean age of 50 years ; 62 % were men and approximately 27 % had preexisting coronary artery disease . Simvastatin was titrated to the maximal daily dose of 40 mg each evening in 56 % of the study population ( last recorded dose ) . The most frequently reported drug-related clinical adverse experiences were constipation ( 2.5 % ) , abdominal pain ( 2.2 % ) , flatulence ( 2.0 % ) and headaches ( 1 % ) . Persistent elevations of serum transaminase levels greater than 3 times the upper limit of normal were observed in only 1 % of this cohort with only 0.1 % of the total population requiring discontinuation of therapy . There were no clinical ly apparent episodes of hepatitis . Discontinuation of therapy due to myopathy was extremely rare ( 0.08 % ) . Only minimal increases in the frequency of lens opacities ( 1 % ) were observed from baseline to the last lens examination during follow-up , consistent with the expected increase in lens opacity development due to normal aging . Patients who were greater than or equal to 65 years old had a clinical and laboratory safety profile comparable to the nonelderly population . ( ABSTRACT TRUNCATED AT 250 WORDS

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Effects of lovastatin on cognitive function and psychological well-being.

PURPOSE Animal research and cross-sectional studies suggest that serum lipid concentrations may influence cognitive function , mood , and behavior , but few clinical trials have studied these effects . SUBJECTS AND METHODS In this double-blind investigation , 209 generally healthy adults with a serum low-density-lipoprotein ( LDL ) cholesterol level of 160 mg/dL or higher were r and omly assigned to 6-month treatment with lovastatin ( 20 mg ) or placebo . Assessment s of neuropsychological performance , depression , hostility , and quality of life were conducted at baseline and at the end of the treatment period . Summary effect sizes were estimated as z scores on a st and ard deviation ( SD ) scale . RESULTS Placebo-treated subjects improved between baseline and posttreatment periods on neuropsychological tests in all five performance domains , consistent with the effects of practice on test performance ( all P < 0.04 ) , whereas those treated with lovastatin improved only on tests of memory recall ( P = 0.03 ) . Comparisons of the changes in performance between placebo- and lovastatin-treated subjects revealed small , but statistically significant , differences for tests of attention ( z score = 0.18 ; 95 % confidence interval ( CI ) , 0.06 to 0.31 ; P = 0.005 ) and psychomotor speed ( z score = 0.17 ; 95 % CI , 0.05 to 0.28 ; P = 0 . 004 ) that were consistent with greater improvement in the placebo group . Psychological well-being , as measured several ways , was not affected by lovastatin . CONCLUSION Treatment of hypercholesterolemia with lovastatin did not cause psychological distress or substantially alter cognitive function . Treatment did result in small performance decrements on neuropsychological tests of attention and psychomotor speed , the clinical importance of which is uncertain

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Primary prevention of cardiovascular disease with pravastatin in Japan (MEGA Study): a prospective randomised controlled trial

BACKGROUND Evidence -based treatment for hypercholesterolaemia in Japan has been hindered by the lack of direct evidence in this population . Our aim was to assess whether evidence for treatment with statins derived from western population s can be extrapolated to the Japanese population . METHODS In this prospect i ve , r and omised , open-labelled , blinded study , patients with hypercholesterolaemia ( total cholesterol 5.69 - 6.98 mmol/L ) and no history of coronary heart disease or stroke were r and omly assigned diet or diet plus 10 - 20 mg pravastatin daily . The primary endpoint was the first occurrence of coronary heart disease . Statistical analyses were done by intention to treat . This trial is registered at Clinical Trials.gov , number NCT00211705 . FINDINGS 3966 patients were r and omly assigned to the diet group and 3866 to the diet plus pravastatin group . Mean follow-up was 5.3 years . At the end of study , 471 and 522 patients had withdrawn , died , or been lost to follow-up in the diet and diet plus pravastatin groups , respectively . Mean total cholesterol was reduced by 2.1 % ( from 6.27 mmol/L to 6.13 mmol/L ) and 11.5 % ( from 6.27 mmol/L to 5.55 mmol/L ) and mean LDL cholesterol by 3.2 % ( from 4.05 mmol/L to 3.90 mmol/L ) and 18.0 % ( from 4.05 mmol/L to 3.31 mmol/L ) in the diet and the diet plus pravastatin groups , respectively . Coronary heart disease was significantly lower in the diet plus pravastatin group than in the diet alone group ( 66 events vs 101 events ; HR 0.67 , 95 % CI 0.49 - 0.91 ; p=0.01 ) . There was no difference in the incidence of malignant neoplasms or other serious adverse events between the two groups . INTERPRETATION Treatment with a low dose of pravastatin reduces the risk of coronary heart disease in Japan by much the same amount as higher doses have shown in Europe and the USA

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Long-term follow-up of the West of Scotland Coronary Prevention Study.

BACKGROUND The West of Scotl and Coronary Prevention Study was a r and omized clinical trial comparing pravastatin with placebo in men with hypercholesterolemia who did not have a history of myocardial infa rct ion , with an average follow-up of approximately 5 years . The combined outcome of death from definite coronary heart disease or definite nonfatal myocardial infa rct ion was reduced from 7.9 to 5.5 % ( P<0.001 ) in the treatment group . Extended follow-up data were obtained for approximately 10 years after completion of the trial . METHODS For the survivors of the trial , all deaths , hospitalizations and deaths due to coronary events and stroke , and incident cancers and deaths from cancer were tracked with the use of a national computerized record-linkage system . The results were analyzed with time-to-event analyses and use of Cox proportional-hazards models . RESULTS Five years after the trial ended , 38.7 % of the original statin group and 35.2 % of the original placebo group were being treated with a statin . In the period approximately 10 years after completion of the trial , the risk of death from coronary heart disease or nonfatal myocardial infa rct ion was 10.3 % in the placebo group and 8.6 % in the pravastatin group ( P=0.02 ) ; over the entire follow-up period , the rate was 15.5 % in the placebo group and 11.8 % in the pravastatin group ( P<0.001 ) . Similar percentage reductions were seen in the combined rate of death from coronary heart disease and hospitalization for coronary events for both periods . The rate of death from cardiovascular causes was reduced ( P=0.01 ) , as was the rate of death from any cause ( P=0.03 ) , over the entire follow-up period . There were no excess deaths from noncardiovascular causes or excess fatal or incident cancers . CONCLUSIONS In this analysis , 5 years of treatment with pravastatin was associated with a significant reduction in coronary events for a subsequent 10 years in men with hypercholesterolemia who did not have a history of myocardial infa rct ion

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Effect of statins on a wide range of health outcomes: a cohort study validated by comparison with randomized trials.

AIMS To assess the effect of statins on a range of health outcomes . METHODS We undertook a population -based cohort study to assess the effect of statins on a range of health outcomes using a propensity score-based method to control for differences between people prescribed and not prescribed statins . We vali date d our design by comparing our results for vascular outcomes with the effects established in large r and omized trials . The study was based on the United Kingdom Health Improvement Network data base that includes the computerized medical records of over four and a half million patients . RESULTS People who initiated treatment with a statin ( n = 129,288 ) were compared with a matched sample of 600,241 people who did not initiate treatment , with a median follow-up period of 4.4 years . Statin use was not associated with an effect on a wide range of outcomes , including infections , fractures , venous thromboembolism , gastrointestinal haemorrhage , or on specific eye , neurological or autoimmune diseases . A protective effect against dementia was observed ( hazard ratio 0.80 , 99 % confidence interval 0.68 , 0.95 ) . There was no effect on the risk of cancer even after > or = 8 years of follow-up . The effect sizes for statins on vascular end-points and mortality were comparable to those observed in large r and omized trials , suggesting bias and confounding had been well controlled for . CONCLUSIONS We found little evidence to support wide-ranging effects of statins on health outcomes beyond their established beneficial effect on vascular disease

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Unintended effects of statins in men and women in England and Wales: population based cohort study using the QResearch database

Objective To quantify the unintended effects of statins according to type , dose , and duration of use . Design Prospect i ve open cohort study using routinely collected data . Setting 368 general practice s in Engl and and Wales supplying data to the Q Research data base . Participants 2 004 692 patients aged 30 - 84 years of whom 225 922 ( 10.7 % ) were new users of statins : 159 790 ( 70.7 % ) were prescribed simvastatin , 50 328 ( 22.3 % ) atorvastatin , 8103 ( 3.6 % ) pravastatin , 4497 ( 1.9 % ) rosuvastatin , and 3204 ( 1.4 % ) fluvastatin . Methods Cox proportional hazards models were used to estimate effects of statin type , dose , and duration of use . The number needed to treat ( NNT ) or number needed to harm ( NNH ) was calculated and numbers of additional or fewer cases estimated for 10 000 treated patients . Main outcome measure First recorded occurrence of cardiovascular disease , moderate or serious myopathic events , moderate or serious liver dysfunction , acute renal failure , venous thromboembolism , Parkinson ’s disease , dementia , rheumatoid arthritis , cataract , osteoporotic fracture , gastric cancer , oesophageal cancer , colon cancer , lung cancer , melanoma , renal cancer , breast cancer , or prostate cancer . Results Individual statins were not significantly associated with risk of Parkinson ’s disease , rheumatoid arthritis , venous thromboembolism , dementia , osteoporotic fracture , gastric cancer , colon cancer , lung cancer , melanoma , renal cancer , breast cancer , or prostate cancer . Statin use was associated with decreased risks of oesophageal cancer but increased risks of moderate or serious liver dysfunction , acute renal failure , moderate or serious myopathy , and cataract . Adverse effects were similar across statin types for each outcome except liver dysfunction where risks were highest for fluvastatin . A dose-response effect was apparent for acute renal failure and liver dysfunction . All increased risks persisted during treatment and were highest in the first year . After stopping treatment the risk of cataract returned to normal within a year in men and women . Risk of oesophageal cancer returned to normal within a year in women and within 1 - 3 years in men . Risk of acute renal failure returned to normal within 1 - 3 years in men and women , and liver dysfunction within 1 - 3 years in women and from three years in men . Based on the 20 % threshold for cardiovascular risk , for women the NNT with any statin to prevent one case of cardiovascular disease over five years was 37 ( 95 % confidence interval 27 to 64 ) and for oesophageal cancer was 1266 ( 850 to 3460 ) and for men the respective values were 33 ( 24 to 57 ) and 1082 ( 711 to 2807 ) . In women the NNH for an additional case of acute renal failure over five years was 434 ( 284 to 783 ) , of moderate or severe myopathy was 259 ( 186 to 375 ) , of moderate or severe liver dysfunction was 136 ( 109 to 175 ) , and of cataract was 33 ( 28 to 38 ) . Overall , the NNHs and NNTs for men were similar to those for women , except for myopathy where the NNH was 91 ( 74 to 112 ) . Conclusions Cl aims of unintended benefits of statins , except for oesophageal cancer , remain unsubstantiated , although potential adverse effects at population level were confirmed and quantified . Further studies are needed to develop utilities to individualise the risks so that patients at highest risk of adverse events can be monitored closely

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Two-year statin therapy does not alter the progression of intima-media thickness in patients with type 2 diabetes without manifest cardiovascular disease.

OBJECTIVE Cardiovascular disease ( CVD ) is the most important cause of mortality in patients with type 2 diabetes . We aim ed to determine the effect of statin therapy versus placebo on the progression of carotid intima-media thickness ( IMT ) in type 2 diabetic patients without manifest CVD . RESEARCH DESIGN AND METHODS A r and omized , placebo-controlled , double-blind clinical trial was performed in 250 patients with type 2 diabetes . Patients were given either 0.4 mg cerivastatin or placebo daily . In August 2001 , when cerivastatin was withdrawn from the market , 0.4 mg cerivastatin was replaced by 20 mg simvastatin without deblinding the study . The primary end point was the change of mean common carotid IMT , as measured by B-mode ultrasound , over 2 years . RESULTS Common carotid IMT at baseline was 0.780 mm in the placebo group and 0.763 mm in the statin group and did not change significantly after 2 years . There was no significant difference in IMT change in any carotid segment between the groups . LDL cholesterol was reduced by 25 % in the statin group and increased by 8 % in the placebo group ( P < 0.001 ) . Cardiovascular events occurred in 12 patients in the placebo group and two patients in the statin group ( P=0.006 ) . CONCLUSIONS There was no effect of 2 years ' statin therapy on carotid IMT in type 2 diabetic subjects . The natural history of IMT in our patients was milder than anticipated . In contrast , we observed a significantly lower cardiovascular event rate on statin therapy . Prognostic tools other than IMT should be explored in this patient group

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Ethnic variations in lipid-lowering in response to a statin (EVIREST): a substudy of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT).

BACKGROUND Statins improve lipid profiles and reduce cardiovascular morbidity and mortality but there are few data on their relative effects in different ethnic groups . METHODS We used data from the r and omised , placebo-controlled Anglo-Sc and inavian Cardiac Outcomes Trial-Lipid Lowering Arm ( ASCOT-LLA ) to conduct a prespecified comparison of the lipid-lowering efficacy of statin therapy among hypertensive participants from different ethnic groups in the UK and Irel and . The effects of atorvastatin ( 10 mg daily ) and placebo on fasting plasma lipid profiles were compared in matched groups of Whites and Blacks ( of African-Caribbean or African origin ) and Whites and South Asians ( from the Indian subcontinent ) , adjusting for placebo effect . RESULTS In the active treatment group , 156 Blacks and 72 South Asians were compared with 419 and 198 Whites , respectively . In multivariable analyses adjusted for baseline lipid levels and other potential confounders , atorvastatin reduced total cholesterol , low-density lipoprotein (LDL)-cholesterol and triglycerides from baseline in all ethnic groups . There were no clinical ly or statistically significant differences in the effect between Whites and Blacks or between Whites and South Asians after adjusting for placebo effect ; similar proportions in each group achieved lipid targets . There was no significant effect of atorvastatin on high-density lipoprotein (HDL)-cholesterol in any group . CONCLUSIONS A st and ard dose of atorvastatin improved lipid profiles to a similar extent in Whites , Blacks and South Asians . Given the proven benefits of statins , these results suggest that , when used in st and ard doses , they are likely to be similarly effective for cardiovascular disease prevention in all ethnic groups

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Statins, antihypertensive treatment, and blood pressure control in clinic and over 24 hours: evidence from PHYLLIS randomised double blind trial

Objective To investigate the possibility that statins reduce blood pressure as well as cholesterol concentrations through clinic and 24 hour ambulatory blood pressure monitoring . Design R and omised placebo controlled double blind trial . Setting 13 hospitals in Italy Participants 508 patients with mild hypertension and hypercholesterolaemia , aged 45 to 70 years . Intervention Participants were r and omised to antihypertensive treatment ( hydrochlorothiazide 25 mg once daily or fosinopril 20 mg once daily ) with or without the addition of a statin ( pravastatin 40 mg once daily ) . Main outcome measures Clinic and ambulatory blood pressure measured every year throughout an average 2.6 year treatment period . Results Both the group receiving antihypertensive treatment without pravastatin ( n=254 ) ( with little change in total cholesterol ) and the group receiving antihypertensive treatment with pravastatin ( n=253 ) ( with marked and sustained reduction in total cholesterol and low density lipoprotein cholesterol ) had a clear cut sustained reduction in clinic measured systolic and diastolic blood pressure as well as in 24 hour , and day and night , systolic and diastolic blood pressure . Pravastatin performed slightly worse than placebo , and between group differences did not exceed 1.9 ( 95 % confidence interval −0.6 to 4.3 , P=0.13 ) mm Hg throughout the treatment period . This was also the case when participants who remained on monotherapy with hydrochlorothiazide or fosinopril throughout the study were considered separately . Conclusions Administration of a statin in hypertensive patients in whom blood pressure is effectively reduced by concomitant antihypertensive treatment does not have an additional blood pressure lowering effect . Trial registration BRISQUI_*IV_2004_001 ( registered at Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali — National Monitoring Centre on Clinical Research with Medicines )

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Rosuvastatin for primary prevention in patients with European systematic coronary risk evaluation risk ≥5% or Framingham risk >20%: post hoc analyses of the JUPITER trial requested by European health authorities

Aims On the basis of the JUPITER trial , European health authorities recently approved the use of rosuvastatin to reduce first major cardiovascular events among ‘ high ' global risk primary prevention patients defined either by Framingham risk score > 20 % or European systematic coronary risk evaluation ( SCORE ) ≥5 % . However , as these are post hoc analyses , data describing these subgroups have not previously been available to the clinical community . Methods and results We r and omized 17 802 apparently healthy men aged ≥50 and women ≥60 with low-density lipoprotein cholesterol ( LDL-C ) < 3.4 mmol/L , who were at an increased vascular risk due to elevated levels of C-reactive protein measured with a high-sensitivity ( hs ) assay to rosuvastatin 20 mg daily or placebo . Patients with high global cardiovascular risk at baseline were identified by 10-year Framingham risk score > 20 % or SCORE risk ≥5 % . During 1.8-year median follow-up ( maximum 5 years ) of patients with Framingham risk > 20 % , the rate of myocardial infa rct ion/stroke/cardiovascular death was 9.4 and 18.2 per 1000 person-years in rosuvastatin and placebo-allocated patients , respectively [ hazard ratio ( HR ) : 0.50 , 95 % confidence interval ( CI ) : 0.27–0.93 , P = 0.028 ] . Among patients with SCORE risk ≥5 % , the corresponding rates were 6.9 and 12.0 using a model extrapolating risk for age ≥65 years ( HR : 0.57 , 95 % CI : 0.43–0.78 , P = 0.0003 ) and rates were 5.9 and 12.7 when risk for age was capped at 65 years ( HR : 0.47 , 95 % CI : 0.32–0.68 , P < 0.0001 ) . Conclusion In primary prevention patients with elevated hs C-reactive protein who have high global cardiovascular risk ( 10-year Framingham risk score > 20 % or SCORE risk ≥5 % ) , but LDL-C levels not requiring pharmacologic treatment , rosuvastatin 20 mg significantly reduced major cardiovascular events . Clinical Trial.gov Identifier :

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Effect of lifestyle and/or statin treatment on soluble markers of atherosclerosis in hypertensives

Objectives . To investigate the independent and combined effects of lifestyle changes and statin treatment on soluble markers of atherosclerotic activity . Design . The study was a r and omised , 2 × 2 factorial 1 year intervention trial . Participants ( n=177 ) were sedentary , drug-treated , hypertensive men ( aged 40–74 years ) . They were r and omised to placebo , lifestyle intervention ( diet and physical activity ) , fluvastatin 40 mg , or the combination of lifestyle and fluvastatin . Results . Lifestyle intervention significantly reduced intercellular adhesion molecule-1 ( sICAM-1 ) compared to usual care ( p=0.003 ) . Thrombomodulin level remained higher among individuals receiving lifestyle intervention ( p=0.025 ) . sICAM-1 was less reduced among fluvastatin treated participants compared to the placebo treated ( p=0.029 ) . Changes of blood pressure , weight or waist circumference were not significantly different between treatment groups . Individuals who achieved improvement of classical risk factors also had a significant reduction of endothelial markers ( E-selectin , von Willebr and s factor , tissue plasminogen activator antigen ) . Conclusions . One year of lifestyle intervention reduced the level of sICAM-1 in sedentary , drug-treated hypertensives , in spite of no impact on traditional risk factors . Low dose fluvastatin had no beneficial effect on the measured markers

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Primary prevention of vascular events in patients with high levels of C-reactive protein: the JUPITER study

The Justification for the Use of Statins in Primary Prevention : An Intervention Trial Evaluating Rosuvastatin ( JUPITER ) study was the first large-scale , prospect i ve study to examine the benefits of statin therapy in subjects with elevated levels of high-sensitivity C-reactive protein but with low-to-normal LDL-cholesterol levels , who were not qualified for lipid-lowering treatment according to the current guidelines for primary prevention . The JUPITER study aim ed to determine whether rosuvastatin 20 mg daily would reduce the rate of first major cardiovascular events , including cardiovascular death , nonfatal stroke , nonfatal myocardial infa rct ion , hospitalization for unstable angina or arterial revascularization . Rosuvastatin reduced LDL-cholesterol levels by 50 % and high-sensitivity C-reactive protein by 37 % . Compared with placebo , the combined primary end point was reduced in 44 % ( p < 0.00001 ) , and total mortality in 20 % ( p = 0.02 ) . The trial confirmed the relationship between the rates of major cardiovascular events with both high-sensitivity C-reactive protein and LDL-cholesterol levels achieved after statin treatment . Interestingly , this was the first large , prospect i ve statin trial to show benefit in the reduction of venous thromboembolism

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study.

CONTEXT Although cholesterol-reducing treatment has been shown to reduce fatal and nonfatal coronary disease in patients with coronary heart disease ( CHD ) , it is unknown whether benefit from the reduction of low-density lipoprotein cholesterol ( LDL-C ) in patients without CHD extends to individuals with average serum cholesterol levels , women , and older persons . OBJECTIVE To compare lovastatin with placebo for prevention of the first acute major coronary event in men and women without clinical ly evident atherosclerotic cardiovascular disease with average total cholesterol ( TC ) and LDL-C levels and below-average high-density lipoprotein cholesterol ( HDL-C ) levels . DESIGN A r and omized , double-blind , placebo-controlled trial . SETTING Outpatient clinics in Texas . PARTICIPANTS A total of 5608 men and 997 women with average TC and LDL-C and below-average HDL-C ( as characterized by lipid percentiles for an age- and sex-matched cohort without cardiovascular disease from the National Health and Nutrition Examination Survey [ NHANES ] III ) . Mean ( SD ) TC level was 5.71 ( 0.54 ) mmol/L ( 221 [ 21 ] mg/dL ) ( 51 st percentile ) , mean ( SD ) LDL-C level was 3.89 ( 0.43 ) mmol/L ( 150 [ 17 ] mg/dL ) ( 60th percentile ) , mean ( SD ) HDL-C level was 0.94 ( 0.14 ) mmol/L ( 36 [ 5 ] mg/dL ) for men and 1.03 ( 0.14 ) mmol/L ( 40 [ 5 ] mg/dL ) for women ( 25th and 16th percentiles , respectively ) , and median ( SD ) triglyceride levels were 1.78 ( 0.86 ) mmol/L ( 158 [ 76 ] mg/dL ) ( 63rd percentile ) . INTERVENTION Lovastatin ( 20 - 40 mg daily ) or placebo in addition to a low-saturated fat , low-cholesterol diet . MAIN OUTCOME MEASURES First acute major coronary event defined as fatal or nonfatal myocardial infa rct ion , unstable angina , or sudden cardiac death . RESULTS After an average follow-up of 5.2 years , lovastatin reduced the incidence of first acute major coronary events ( 1 83 vs 116 first events ; relative risk [ RR ] , 0.63 ; 95 % confidence interval [ CI ] , 0.50 - 0.79 ; P<.001 ) , myocardial infa rct ion ( 95 vs 57 myocardial infa rct ions ; RR , 0.60 ; 95 % CI , 0.43 - 0.83 ; P=.002 ) , unstable angina ( 87 vs 60 first unstable angina events ; RR , 0.68 ; 95 % CI , 0.49 - 0.95 ; P=.02 ) , coronary revascularization procedures ( 157 vs 106 procedures ; RR , 0.67 ; 95 % CI , 0.52 - 0.85 ; P=.001 ) , coronary events ( 215 vs 163 coronary events ; RR , 0.75 ; 95 % CI , 0.61 - 0.92 ; P = .006 ) , and cardiovascular events ( 255 vs 194 cardiovascular events ; RR , 0.75 ; 95 % CI , 0.62 - 0.91 ; P = .003 ) . Lovastatin ( 20 - 40 mg daily ) reduced LDL-C by 25 % to 2.96 mmol/L ( 115 mg/dL ) and increased HDL-C by 6 % to 1.02 mmol/L ( 39 mg/dL ) . There were no clinical ly relevant differences in safety parameters between treatment groups . CONCLUSIONS Lovastatin reduces the risk for the first acute major coronary event in men and women with average TC and LDL-C levels and below-average HDL-C levels . These findings support the inclusion of HDL-C in risk-factor assessment , confirm the benefit of LDL-C reduction to a target goal , and suggest the need for re assessment of the National Cholesterol Education Program guidelines regarding pharmacological intervention

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Race, ethnicity, and the efficacy of rosuvastatin in primary prevention: the Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) trial.

OBJECTIVES The aim of this study was to evaluate the effect of statin treatment in primary prevention of cardiovascular events in different race/ethnic groups . BACKGROUND Clinical trial evidence about the efficacy of statins in the primary prevention of cardiovascular events among nonwhites is uncertain . METHODS JUPITER trial , a r and omized , double-blind , placebo-controlled evaluation of rosuvastatin 20 mg in the primary prevention of myocardial infa rct ion ( MI ) , stroke , arterial revascularization , hospitalization for unstable angina , and cardiovascular death included 12,683 whites and 5,117 nonwhites with low-density lipoprotein levels < 130 mg/dL and high-sensitivity C-reactive protein levels ≥2.0 mg/L. RESULTS R and om allocation to rosuvastatin result ed in a 45 % reduction in the primary end point among whites ( hazard ratio [ HR ] 0.55 , 95 % CI 0.43 - 0.69 ) and a 37 % reduction among nonwhites ( HR 0.63 , 95 % CI 0.41 - 0.99 ) . Blacks ( HR 0.65 , 95 % CI 0.35 - 1.22 ) and Hispanics ( HR 0.58 , 95 % CI 0.25 - 1.39 ) had similar risk reductions . Among nonwhites in the placebo group , the stroke rate exceeded the MI rate ( 0.44 vs 0.20 per 100 person-years ) ; an opposite pattern was observed among whites ( 0.31 vs 0.42 per 100 person-years ) . Nonwhites had higher death rates than whites ( 2.25 vs 0.93 per 100 person-years ) ; however , all-cause mortality was similar at 20 % with rosuvastatin treatment in both participant groups . CONCLUSIONS When used in primary prevention among individuals with low-density lipoprotein < 130 mg/dL and high-sensitivity C-reactive protein ≥2 mg/L , rosuvastatin significantly reduced first MI , stroke , arterial revascularization , hospitalization for unstable angina , and cardiovascular death among whites and nonwhites

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Beneficial effects of pravastatin on fasting hyperinsulinemia in elderly hypertensive hypercholesterolemic subjects.

We undertook this prospect i ve double-blind , placebo-controlled study to evaluate the efficacy and safety of low-dose ( 15 mg ) pravastatin in elderly hypercholesterolemic hypertensive subjects with concurrent antihypertensive treatment and to determine whether fasting hyperinsulinemia could also be improved . At three hypertension and lipid clinics of two medical centers , 96 elderly ( 49 women , 47 men ) ambulatory subjects were r and omized to active treatment or placebo for 12 months after a 3-month single-blind lead-in period . Hypertensive subjects with plasma total cholesterol levels of at least 6.47 mmol/L ( 250 mg/dL ) and triglyceride levels less than 3.39 mmol/L ( 300 mg/dL ) were treated with 15 mg pravastatin for 12 months after receiving 3 months of the American Heart Association step I diet . Lipid , glucose , and fasting insulin levels were measured ; clinical laboratory tests included liver function and creatine kinase determinations . After 12 months of pravastatin therapy , plasma total cholesterol concentration decreased by 25.1 % ( from a mean of 7.29 to 5.47 mmol/L , P < .05 ) , low-density lipoprotein cholesterol decreased by 30.2 % ( from 5.27 to 3.68 mmol/L , P < .05 ) , and triglycerides decreased by 10.7 % ( from 1.68 to 1.50 mmol/L , P < .05 ) . High-density lipoprotein cholesterol increased by 9.2 % ( from 1.20 to 1.31 mmol/L , P < .05 ) . Fasting insulin levels decreased from 89.0 to 61.5 pmol/L ( P < .05 ) . All of these changes were greater ( P < .05 ) than any tendency toward change in the placebo group . Adverse events and clinical laboratory abnormalities were generally mild and transient in both placebo and pravastatin groups . Study drugs were withdrawn from one subject in each group with asymptomatic creatine kinase elevations . We conclude that low-dose pravastatin was effective and safe in the treatment of hypercholesterolemic hypertensive subjects on concurrent antihypertensive therapy . It also improved fasting hyperinsulinemia despite the use of beta-blockers and diuretics in these hypertensive subjects

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Usefulness of HMG-CoA Reductase Inhibitor in Japanese Hyperlipidemic Women within Seven Years of Menopause

Objective : To assess the therapeutic value of treatment with an HMG-CoA reductase inhibitor in women with hypoestrogenic hyperlipidemia caused by menopause . Design : Fifty-six women with total cholesterol ( TC ) levels of 220 mg/dl or more who were within 7 years of menopause were r and omly assigned to receive an HMG-CoA reductase inhibitor ( pravastatin 10 mg/day ; treated group , 26 patients ) or no medical treatment ( nontreated group , 30 patients ) in this 6-month nonblinded prospect i ve trial . Results : In the treated group , the mean ( SD ) TC levels decreased significantly from 254.5 ± 22.3 mg/dl at baseline to 204.7 ± 22.2 mg/dl ( 19.6 % ) , and the mean low-density lipoprotein cholesterol ( LDL-C ) level decreased significantly from 146.7 ± 30.5 to 104.3 ± 22.5 mg/dl ( 28.9 % ) ; the mean arteriosclerotic index decreased significantly from 2.98 to 2.08 ( 30.2 % ) . There were no significant changes in either triglyceride levels or high-density lipoprotein cholesterol ( HDL-C ) levels . In the nontreated group , there were no significant changes in the TC , HDL-C , LDL-C , or triglyceride levels ; there was also no change in the arteriosclerotic index . After 6 months , the TC level , LDL-C level , and arteriosclerotic index were significantly lower in the treated group compared with the nontreated group ( p < 0.01 ) . Conclusions : The results indicate that the HMG-CoA reductase inhibitor lowered TC and LDL-C levels and was useful in the treatment of hypoestrogenic hyperlipidemia for periods of at least 6 months

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Interactive effects of fitness and statin treatment on mortality risk in veterans with dyslipidaemia: a cohort study

BACKGROUND Statins are commonly prescribed for management of dyslipidaemia and cardiovascular disease . Increased fitness is also associated with low mortality and is recommended as an essential part of promoting health . However , little information exists about the combined effects of fitness and statin treatment on all-cause mortality . We assessed the combined effects of statin treatment and fitness on all-cause mortality risk . METHODS In this prospect i ve cohort study , we included dyslipidaemic veterans from Veterans Affairs Medical Centers in Palo Alto , CA , and Washington DC , USA , who had had an exercise tolerance test between 1986 , and 2011 . We assigned participants to one of four fitness categories based on peak metabolic equivalents ( MET ) achieved during exercise test and eight categories based on fitness status and statin treatment . The primary endpoint was all-cause mortality adjusted for age , body-mass index , ethnic origin , sex , history of cardiovascular disease , cardiovascular drugs , and cardiovascular risk factors . We assessed mortality from Veteran 's Affairs ' records on Dec 31 , 2011 . We compared groups with Cox proportional hazard model . FINDINGS We assessed 10,043 participants ( mean age 58·8 years , SD 10·9 years ) . During a median follow-up of 10·0 years ( IQR 6·0 - 14·2 ) , 2318 patients died , with an average yearly mortality rate of 22 deaths per 1000 person-years . Mortality risk was 18·5 % ( 935/5046 ) in people taking statins versus 27·7 % ( 1386/4997 ) in those not taking statins ( p<0·0001 ) . In patients who took statins , mortality risk decreased as fitness increased ; for highly fit individuals ( > 9 MET ; n=694 ) , the hazard ratio ( HR ) was 0·30 ( 95 % CI 0·21 - 0·41 ; p<0·0001 ) compared with least fit ( ≤5 METs ) patients ( HR 1 ; n=1060 ) . For those not treated with statins , the HR for least fit participants ( n=1024 ) was 1·35 ( 95 % CI 1·17 - 1·54 ; p<0·0001 ) and progressively decreased to 0·53 ( 95 % CI 0·44 - 0·65 ; p<0·0001 ) for those in the highest fitness category ( n=1498 ) . INTERPRETATION Statin treatment and increased fitness are independently associated with low mortality among dyslipidaemic individuals . The combination of statin treatment and increased fitness result ed in substantially lower mortality risk than either alone , reinforcing the importance of physical activity for individuals with dyslipidaemia . FUNDING None

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Simvastatin treatment in patients with relapsing-remitting multiple sclerosis receiving interferon beta 1a: a double-blind randomized controlled trial

Objectives : This study was conducted to evaluate the effect of simvastatin ( 40 mg/day ) as an adjuvant therapy to interferon beta ( IFNb 1a , 30 µg once weekly ) in relapsing — remitting multiple sclerosis patients , compared with placebo . Methods : We enrolled 85 patients with relapsing — remitting multiple sclerosis ( 71 % female ) who were already receiving IFNb 1a ( Avonex ) , with Exp and ed Disability Status Scale score of less than 5.0 . The patients were assigned ( in r and om and double-blinded fashion ) into the two groups of simvastatin and placebo . All patients continued to receive their current IFNb treatment . The outcome measures were total relapse rate , Exp and ed Disability Status Scale score , and the number of gadolinium-enhanced ( Gd+ ) and new T2 lesions in magnetic resonance imaging after a 1-year follow-up . We used Mann — Whitney and one-way multivariate analysis of variances to analyze the data . Results : Four patients in the placebo and two in the simvastatin group prematurely withdrew from the study due to experiencing two attacks . The total attack number in the simvastatin group was significantly lower than placebo group ( moderate effect size r = 0.29 ) ( p = 0.01 ) . The final Exp and ed Disability Status Scale scores were lower in the simvastatin group ( 1.01 ± 1.40 , mean ± SD ) than in the placebo group ( 1.73 ± 1.49 , mean ± SD ) , but this difference was not significant after controlling the baseline Exp and ed Disability Status Scale score ( p = 0.07 ) . In the simvastatin group , the mean ± SD of gadolinium-enhanced and new T2 lesions were 0.66 ± 1.18 and 3.39 ± 3.55 , respectively , ( compared with 0.74 ± 1.21 and 3.39 ± 3.55 in the placebo group ) . Although there was a decreasing trend in lesions on magnetic resonance imaging , this difference was not statistically significant ( p = 0.62 ) . The combination therapy was safe and well tolerated , and no serious adverse effect was noted . Conclusion : Our study supports the safety and efficacy of simvastatin as an add-on therapy to INFb 1a in patients with relapsing — remitting multiple sclerosis . TRIAL REGISTRATION : Clinical Trials.gov NCT00668343 . This interventional study provides Class I evidence stating that adding simvastatin 40 mg/day to IFNb 1a 30 µg a week in patients with relapsing — remitting multiple sclerosis may reduce the relapse rate ( moderate effect size r = 0.29 ) ( p = 0.01 ) compared with treatment with IFNb 1a alone

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .

Compliance with and efficacy of treatment with pravastatin and cholestyramine: a randomized study on lipid-lowering in primary care.

OBJECTIVES Lipid-lowering drugs as 3-hydroxy-3-methyl glutaryl coenzyme A ( HMG-CoA ) reductase inhibitors and cholestyramine are effective in reducing cardiovascular morbidity both in primary and secondary prevention . Patient compliance is an important determinant of the outcome of therapy . This study was design ed to compare compliance with tolerance and lipid-lowering effectiveness of pravastatin and /or cholestyramine in primary care . DESIGN Nine hundred and eighty nine women and 1047 men were r and omized to treatment at 100 primary -care centres in Sweden . After dietary intervention , an eligible patient was r and omly assigned to one of four programs of daily treatment : group Q , 16 g cholestyramine , group QP , 8 g cholestyramine and 20 mg pravastatin , group P20 , 20 mg pravastatin or group P40 , 40 mg pravastatin . RESULTS In group Q , group QP , group P20 and group P40 the reductions in low density lipoprotein (LDL)-cholesterol were 26 % , 36 % , 27 % and 32 % . The dose actually taken was 91 - 95 % of the prescribed for the pravastatin treatment groups and 77 - 88 % for the cholestyramine groups . In the pravastatin and cholestyramine groups 76 - 78 % and 44 - 53 % , respectively , completed the trial . Only 8 - 27 % of the patients reached a serum cholesterol target level of 5.2 mmol L-1 . There was no difference in lipid-lowering effect between women and men . CONCLUSION Pravastatin alone is efficacious and compliance is high , independent of dose . Combined treatment with cholestyramine and pravastatin had a better cholesterol lowering effect ( although not statistically significant ) than 40 mg pravastatin . Despite this , only 8 - 27 % of the patients actually reached a serum cholesterol level of 5.2 mmol L-1 . No unexpected serious adverse events were detected in any of the treatment groups . As predicted , the gastrointestinal disturbances were more common on cholestyramine treatment . These two factors suggest that an increase in the dosage of the HMG-CoA reductase inhibitor may be appropriate . Results from other studies indicate that there also might be other positive effects of statin treatment beyond cholesterol lowering

Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects . There was no evidence of any serious harm caused by statin prescription . Evidence available to date showed that primary prevention with statins is likely to be cost-effective and may improve patient quality of life . Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta- analysis indicate that these benefits are similar in people at lower ( < 1 % per year ) risk of a major cardiovascular event . AUTHORS ' CONCLUSIONS Reductions in all-cause mortality , major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins

BACKGROUND Reducing high blood cholesterol , a risk factor for cardiovascular disease ( CVD ) events in people with and without a past history of CVD is an important goal of pharmacotherapy . Statins are the first-choice agents . Previous review s of the effects of statins have highlighted their benefits in people with CVD . The case for primary prevention was uncertain when the last version of this review was published ( 2011 ) and in light of new data an up date of this review is required . OBJECTIVES To assess the effects , both harms and benefits , of statins in people with no history of CVD .