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Almost all side-effects listed for statins are not caused by the drugs, according to the world’s most comprehensive review of evidence.
Other than the well-known risks around muscle pain and diabetes, only four of 66 other statin side-effects listed on labels – liver test changes, minor liver abnormalities, urine changes and tissue swelling – are supported by evidence. And the risks are very small, according to the systematic review and meta-analysis published in the Lancet.
Statins have been used by hundreds of millions of people worldwide over the last three decades and are proven to reduce heart attacks, strokes and cardiovascular deaths. At the same time, millions have been put off the drugs amid long-running safety concerns, with statin labels listing dozens of possible side-effects.
The study is the most comprehensive assessment of evidence for listed side-effects of statins. It examined 19 randomised controlled trials involving 124,000 people, with an average follow-up of four and a half years.
Of the 66 side-effects currently listed on product labels, researchers found no strong evidence to support statins causing 62 of them, such as memory problems, depression, sleep disturbances and nerve damage leading to tingling in the hands and feet.
The results showed the risk of most listed side-effects was minimal while the benefits far outweighed potential harms. As a result, labels should be updated to better reflect the evidence so patients and doctors could make more informed choices about statins, the researchers said.
The study’s lead author, Christina Reith, an associate professor at Oxford University, said: “What we were able to show reliably was that statins did not make these commonly experienced events occur more often.
“So for example, the percentage of people suffering memory loss per year was similar to those taking statin therapy as those not, equally. The percentage of people suffering sleep problems per year was similar to those taking statin therapy as for those not.
“This means that we now have really good evidence that although these things may well happen to people while they take statins, that statins are not the cause of these problems.”
While the study also noted the potential for side-effects appearing after statin use for longer than the average follow-up time, Reith said it provided “reassurance that, for most people, the risk of side-effects is greatly outweighed by the benefits of statins”.
Prof Sir Rory Collins, emeritus professor of medicine and epidemiology at Oxford and a senior author of the paper, said: “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.”
Prof Bryan Williams, chief scientific and medical officer at the British Heart Foundation, which part-funded the research, said: “Statins are life-saving drugs, which have been proven to protect against heart attacks and strokes. This evidence is a much-needed counter to the misinformation around statins and should help prevent unnecessary deaths from cardiovascular disease.”
Prof Victoria Tzortziou Brown, chair of the Royal College of GPs, said: “Those considering taking statins should be reassured by this comprehensive study, which shows that while statins, like any medication, have potential side-effects, the risk for most people is low.
“It remains important to note that while statins can have real benefits for some patients, they won’t be appropriate for everyone so the decision to prescribe should always be the result of a conversation between the GP and patient about the various risks and benefits.”
