Cholesterol-lowering drugs known as statins, taken by millions of people worldwide, are far safer than commonly believed, according to a major scientific review published in The Lancet. Researchers say patient information leaflets should be updated to reflect the evidence and prevent people from being unnecessarily deterred from using the life-saving medication.
The review, funded by the British Heart Foundation and led by researchers from the University of Oxford, analysed data from clinical trials involving more than 120,000 participants. The trials compared people taking statins with those given a placebo.
The findings show that statins do not cause most of the side effects frequently listed in medicine leaflets, including memory loss, depression, sleep problems, weight gain and impotence. Reports of these symptoms were almost identical among patients taking placebo pills, suggesting they were not caused by statins.
Statins are proven to lower “bad” LDL cholesterol and significantly reduce the risk of heart attacks and strokes. Cardiovascular disease remains a leading cause of death globally, accounting for around 10 million deaths each year and about a quarter of all deaths in the UK.
Out of 66 potential side effects examined, only four showed any association with statin use, and only in a small number of patients. These included mild changes in liver blood tests, minor liver abnormalities, changes in urine tests and tissue swelling. Importantly, there was no increase in serious liver disease such as hepatitis or liver failure.
Muscle damage and small increases in blood sugar levels can occur with statins, but researchers emphasise these effects are rare. In some cases, statins may slightly accelerate the onset of diabetes in people already at high risk.
Lead author Professor Christina Reith said concerns about side effects have discouraged many people from starting or continuing statin treatment.
“Confusion and worry mean that many who could benefit either avoid statins or stop taking them,” she said. “This study provides strong reassurance that, for most people, the benefits far outweigh the risks.”
Senior author Professor Sir Rory Collins added that medicine information leaflets should be urgently revised to reflect the evidence, allowing patients and doctors to make better-informed decisions.
British Heart Foundation chief scientific and medical officer Professor Bryan Williams said negative publicity around unproven side effects has led to underuse of statins.
“These findings should provide powerful reassurance. Statins save lives,” he said.
Health experts stress that anyone experiencing symptoms while taking statins should speak with their doctor, rather than stopping medication without medical advice.
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