Most listed statin side-effects are not caused by the drug, study finds

Health information around statins should be revised as most side-effects listed in the product labels are not caused by the drugs, a major new study has found.

The study, which was published in The Lancet, analysed data from 23 large randomised controlled trials using cholesterol-lowering medicine statins and involved more than 120,000 participants.

All the trials included were more than two years long, and 19 were placebo controlled. The remaining four trials compared different statin doses.

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The authors, led by Dr Christina Reith from the Nuffield Department of Population Health at the University of Oxford, found that only four of the 66 listed adverse outcomes were attributable to statins. These were: liver test changes, minor liver abnormalities, urine changes, and tissue swelling or swollen ankles.

Conversely, they found that side-effects, such as cognitive impairment, depression, and sleep disturbance were not causally linked to the drug.

In light of these new findings, the authors say that labelling and other official sources of health information should be revised so that patients and their health-care providers can make appropriately informed decisions regarding statin therapy.

Dr Reith said: ‘Statins are life-saving drugs used by hundreds of millions of people over the past 30 years.

‘However, concerns about the safety of statins have deterred many people who are at risk of severe disability or death from a heart attack or stroke.

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‘Our study provides reassurance that, for most people, the risk of side effects is greatly outweighed by the benefits of statins.’

The British Heart Foundation’s, chief scientific and medical officer, Professor Bryan Williams, said: ‘These findings are hugely important and provide authoritative, evidence-based reassurance for patients. Statins are lifesaving drugs, which have been proven to protect against heart attacks and strokes.

‘Among the large number of patients assessed in this well-conducted analysis, only four side effects out of 66 were found to have any association with taking statins, and only in a very small proportion of patients.

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‘This evidence is a much-needed counter to the misinformation around statins and should help prevent unnecessary deaths from cardiovascular disease. Recognising which side effects might genuinely be associated with statins is also important as it will help doctors make decisions about when to use alternative treatments.’

A version of this article was first published on our sister title, The Pharmacist