Overview
- An Oxford-led meta-analysis of 23 randomized trials covering more than 154,000 participants and about 38 million symptom reports found no excess risk for almost all conditions cited on statin leaflets.
- Of 66 label-listed adverse outcomes, only four showed slight increases, with no higher rates of memory loss, depression, sleep disturbance, erectile dysfunction, headaches or weight gain versus placebo.
- The study confirms small absolute risks including about a 1% excess of muscle symptoms mainly in the first year, a modest rise in blood sugar for some, roughly a 0.1% increase in abnormal liver tests, and tiny upticks in edema and urine changes, with no increase in serious liver disease.
- Study authors and major cardiac organizations are urging regulators and manufacturers to revise patient information leaflets, with early discussions reported but formal label changes expected to take time.
- Experts warn that misinformation has led some patients to stop statins, citing research linking a 2013 Australian media scare to thousands of projected additional heart attacks and strokes, and they say clearer communication could widen appropriate use.