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Unblinded ASCOT study results do not rule out that muscle symptoms are an adverse effect of statins
  1. Bhavin B Adhyaru1,
  2. Terry A Jacobson2
  1. 1 Division of General Medicine and Geriatrics, Emory University, Atlanta, Georgia, USA
  2. 2 Lipid Clinic and Cardiovascular Risk Reduction Program, Emory University, Atlanta, Georgia, USA
  1. Correspondence to Dr Bhavin B Adhyaru, Division of General Medicine and Geriatrics, Emory University, Atlanta, Georgia 30322, USA; badhyar{at}emory.edu

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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.

Context

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.

Methods

The first trial phase was a randomised, blinded phase that included 10 180 patients aged 40–79 years with …

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