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Commentary
Primary care
Therapeutics
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. 1Division of General Medicine and Geriatrics, Emory University, Atlanta, Georgia, USA
  2. 2Lipid 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

https://doi.org/10.1136/ebmed-2017-110783

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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 …

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    Footnotes

    • Competing interests TJ has received research and consulting fees from Amgen and Regeneron/Sanofi.

    • Provenance and peer review Commissioned; internally peer reviewed.