Statins do not usually cause muscle pain, the world’s most comprehensive study of their risks has found, prompting health experts to reassure millions of patients that taking the pills is safe.
The drugs are widely prescribed to prevent heart disease, but for years there have been concerns that they can often cause pain or muscle weakness.
Now, a study presented at the Congress of the European Society of Cardiology in Barcelona and published in the Lancet actually disproves this belief.
“The idea that statins can cause frequent muscle pain has been a persistent belief among some patients and doctors. However, our study confirms that the statin is rarely the cause of muscle pain in those taking statins,” he said. Professor Colin Baigent, Director of the Medical Research Council’s Population Health Research Unit at the University of Oxford and joint lead author of the study. .
“These findings suggest that if a patient on statins reports muscle pain, it should first be assumed that the symptoms are not due to the statin and are most likely due to other causes.”
Statins are one of the most prescribed drugs. Eight million people in the UK take them, as do millions more worldwide.
“Drug regulators around the world are concerned about keeping patients safe,” Baigent said. “And so far they’ve thought that doing it is better to have these warnings about the possibility of muscle soreness.
“What we’ve shown is that that’s actually not the best way to treat patients, because patients take that information and the moment they develop muscle pain they suspect the statin and that makes a lot of they prescribe the statin, which actually puts them in harm’s way.
“And so we need to try to shift the balance of that and work with regulators to do a better job of communicating the risks.”
An analysis of data covering 155,000 patients from 23 statin trials found that when a patient reported muscle symptoms while taking a statin, there was less than a 10% chance the pain was caused by the drug. It also suggested that the small increased risk of muscle symptoms was mainly seen during the first year of treatment.
Professor Sir Nilesh Samani, medical director of the British Heart Foundation, which co-funded the study, said: “This accumulation of data from many clinical trials provides a clear picture that, while statins are associated with a small increase of the risk of muscle pain or weakness, do not cause most of the muscle pain symptoms commonly associated with it.
“It strengthens the evidence that statins are safe, which should reassure many people taking, or considering taking, these life-saving drugs that have been shown to protect against heart attacks and strokes.”
After the first year of the 23 trials, there was no significant increase in the risk of reporting muscle pain. The researchers said the risk of muscle symptoms caused by statins should be considered alongside the cardiovascular benefits of the therapy.
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Given the findings, they call for a review of recommended strategies for controlling muscle pain while using statins and for a review of drug label information.
Dr Christina Reith, senior clinical researcher at Oxford Population Health and joint lead author of the study, said: “We hope these results will help clinicians and patients make informed decisions about whether to start or continue therapy with statins, bearing in mind their significant known benefits in reducing the risk of cardiovascular disease.”
The study found that among 19 clinical trials that also involved people receiving a placebo, 27.1% of patients who received statins reported muscle pain or weakness, compared with 26.6% of those who receive the placebo.
After the first year of treatment there was no significant difference in reports of muscle pain or weakness between those who received statins and those who received the placebo, the study found.
The Oxford researchers stressed that if patients experienced muscle symptoms they should tell their GP, and also acknowledged that in very rare cases the drug can cause quite serious muscle damage.