Reports of increased rates of muscle pain and weakness in observational studies have led to claims that as many as 20% of patients have "statin intolerance", mainly due to muscle pain and weakness. The randomised trial evidence demonstrate that these claims represent misattribution of symptoms to the statin therapy. Instead, at most, statin therapy causes an increase in symptomatic adverse events (such as muscle pain and weakness) in about 10-20 of 10,000 treated patients per year.

It has been claimed, based on observational studies, that statin therapy might increase the risks of various other conditions (including memory loss, cataracts, kidney injury, liver disease, sleep disturbance, aggression, suicidal behavioural, erectile disjunction and neuropathy). However, the evidence from the randomised trials shows that these associations in observational studies do not reflect a causal effect of statin therapy.


Writing in a linked Comment, Dr Richard Horton, editor-in-chief of The Lancet says: "Controversy over the safety and efficacy of statins has harmed the health of potentially thousands of people in the UK... That is why we are this week publishing a comprehensive scientific review about the efficacy and safety of statin therapy by researchers who have made substantial contributions to the science of statins. The purpose of this review is to help doctors and patients make informed decisions about the use of this important drug class."

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