Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial—Lipid-Lowering Arm (ASCOT-LLA)

No excess of muscle-related AEs was reported among patients receiving atorvastatin during blinded phase: 2.03%/year vs 2% in the placebo group; HR 1.03; p=0.72. During the non-blinded phase, a significant excess in muscle-related AEs was reported (1.26%/year vs 1%; 1.41; p=0.006)

This RCT compared rates of adverse events (AEs) during a blinded randomised atorvastatin therapy phase when atorvastatin 10mg daily was compared with placebo with those during a non-blinded non-randomised statin therapy phase when patients were offered open-label statin using an identical follow-up procedure and AE ascertainment process in the same population in the Lipid-Lowering Arm (LLA) of the Anglo-Scandinavian Cardiac Outcomes Trial.

 

In a related editorial, the author notes that muscle-related AE rates are often argued to be low in randomised controlled trials owing to patient selection. Thus, the strengths of this study lie in the fact that these were the same patients, no run-in period existed to exclude patients intolerant to therapy, and few patients had previously taken any statins. Additionally, the atorvastatin dose typically used in the non-blinded phase was the same as in the blinded phase.