British Heart Foundation study finds medicine misinformation
A study part-funded by the British Heart Foundation and published in The Lancet found that statins do not cause the majority of the conditions that have been listed in their package leaflets. Statins are a cholesterol-lowering medication that can help prevent heart and circulatory conditions. However, concerns about possible side effects and the safety of statins have deterred many people. Researchers have now found misinformation about the side effects listed in package leaflets and have called for a rapid revision of the information.
The researchers, led by a team at Oxford Population Health, assessed data from over 150,000 participants in 23 clinical trials – 19 trials compared the effects of statin therapies against a placebo (or dummy tablet), and four compared more intensive versus less intensive statin therapy. The analysis showed there is no excess risk from statin therapy for almost all the conditions listed in package leaflets as potential side effects. The side effects investigated included memory loss or dementia, depression, sleep disturbance, erectile dysfunction, weight gain, nausea, fatigue or headache, and many other conditions.
Countering misinformation and providing reassurance
Professor Bryan Williams, the British Heart Foundation's chief scientific and medical officer, 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. 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.”
Information needs rapid revision
Professor Sir Rory Collins, Emeritus Professor of Medicine and Epidemiology at Oxford Population Health and senior author of the paper, said: “Statin product labels list certain adverse health outcomes as potential treatment-related effects based mainly on information from non-randomised studies which may be subject to bias. We brought together all of the information from large, randomised trials to assess the evidence reliably. Now that we know that statins do not cause the majority of side effects listed in package leaflets, statin information requires rapid revision to help patients and doctors make better-informed health decisions.”
Find out more about the study and statins on the BHF website here.