{"title":"Unblinded ASCOT study results do not rule out that muscle symptoms are an adverse effect of statins.","authors":"Bhavin B Adhyaru, Terry A Jacobson","doi":"10.1136/ebmed-2017-110783","DOIUrl":null,"url":null,"abstract":"Commentary on : Gupta A and ASCOT investigators. Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid-Lowering Arm (ASCOT-LLA): a randomised double-blind placebo-controlled trial and its non-randomised non-blind extension phase. Lancet 2017;389:2473–81.\n\nSeveral studies suggest that the low adherence rates with statin therapy are related to adverse events, particularly statin-associated muscle symptoms (SAMS).1 Rates of SAMS are found to be much higher in observational studies (10%–20%) compared with randomised controlled trials (RCTs) (1%–3%), which often find little difference in adverse events between statin and placebo groups.2 3 This study, having both blinded and unblinded phases, offers a unique perspective in looking at adverse events with statin therapy.\n\nThe first trial phase was a randomised, blinded phase that included 10 180 patients aged 40–79 years with …","PeriodicalId":12182,"journal":{"name":"Evidence-Based Medicine","volume":" ","pages":"210"},"PeriodicalIF":0.0000,"publicationDate":"2017-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/ebmed-2017-110783","citationCount":"3","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Evidence-Based Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1136/ebmed-2017-110783","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2017/10/22 0:00:00","PubModel":"Epub","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 3
Abstract
Commentary on : Gupta A and ASCOT investigators. Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid-Lowering Arm (ASCOT-LLA): a randomised double-blind placebo-controlled trial and its non-randomised non-blind extension phase. Lancet 2017;389:2473–81.
Several studies suggest that the low adherence rates with statin therapy are related to adverse events, particularly statin-associated muscle symptoms (SAMS).1 Rates of SAMS are found to be much higher in observational studies (10%–20%) compared with randomised controlled trials (RCTs) (1%–3%), which often find little difference in adverse events between statin and placebo groups.2 3 This study, having both blinded and unblinded phases, offers a unique perspective in looking at adverse events with statin therapy.
The first trial phase was a randomised, blinded phase that included 10 180 patients aged 40–79 years with …