Statin side-effects mostly not caused by the drugs, study finds

A Lancet systematic review of 19 randomised trials involving about 124,000 people found no strong evidence that statins cause most of the side-effects listed on product labels; only a few small risks beyond known muscle symptoms and increased blood sugar had supporting evidence.

A large systematic review and meta-analysis published in The Lancet reports that most side-effects listed for statins are not supported by trial evidence. The research pooled 19 randomised controlled trials with about 124,000 participants and an average follow-up of 4.5 years. Apart from known links with muscle symptoms and a small increase in blood sugar associated with diabetes, only four of 66 additional listed side-effects had evidence supporting an association. Authors and medical organisations say this evidence should prompt clearer product information. What the review found: - The analysis combined data from 19 randomised controlled trials covering about 124,000 people with mean follow-up of roughly 4.5 years. - Researchers found no strong evidence that statins cause 62 of 66 listed side-effects, including complaints such as memory problems, depression, sleep disturbance and tingling in hands and feet. - Confirmed small excess risks included previously recognised muscle symptoms (reported as a small increase, often in the first year) and a modest rise in blood sugar that can advance a diagnosis of diabetes for some people. - Additional, limited evidence supported small increases in abnormal liver blood tests (reported as a very small absolute risk), minor liver abnormalities, changes to urine, and swelling of legs or ankles (oedema). - The review reiterated that statins are proven to reduce heart attacks, strokes and cardiovascular deaths, and the authors and some medical bodies called for label information to be updated to reflect the evidence. Summary: The review reinforces that, for most people, the reductions in cardiovascular events attributed to statins outweigh the small harms shown in trials. Authors and professional groups say product information should be revised so it aligns with current evidence. Undetermined at this time.