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Statins, which are used to lower the level of low-density lipoprotein (or ‘bad’) cholesterol, are unlikely to cause muscle pain, according to the best analysis of data to date.
Previously, statin therapy has been widely thought to cause muscle pain or weakness. This has caused some patients to stop statin therapy prematurely, putting them at increased risk of cardiovascular disease.
Professor Colin Baigent, Director of the Medical Research Council Population Health Research Unit at the University of Oxford, and joint lead author of the study, says he hopes this new research will prompt a revision of the information in the medication label for statins, to clarify that most muscle pain experienced during statin therapy is not due to the statins.
A similar number of patients reported muscle pains
The study included data from 155,000 patients from 23 trials of statin therapy. Each trial had over 1,000 patients and a follow-up time of over two years and had a double-blind comparison of statin vs placebo.
The authors compared rates of muscle symptoms in the group undergoing statin treatment with the placebo group to calculate the proportion of symptoms directly caused by the statin therapy.
The meta-analysis found that roughly a quarter of participants who were given statins or the placebo reported muscle pain or weakness (27.1% and 26.6% respectively).
During the first year of treatment, statin therapy produced a 7% relative increase in muscle pain or weakness compared to placebo, suggesting that only one in 15 of these muscle-related reports by patients given statins were due to the statin.
The absolute excess risk of muscle symptoms due to a statin was 11 per 1,000 patients treated during the first year. After the first year of treatment, there was no significant difference in reports of muscle pain or weakness between those given statins and those given the placebo.
High-intensity treatments
The researchers also compared more intensive versus less intensive statin therapy, and found no clear evidence of a dose-response relationship.
However, in the first year of treatment, the higher intensity statins caused a greater increase in the risk of muscle pain caused by statins compared to placebo (an 11% increase in risk) than moderate-intensity statin treatment compared to placebo (a 6% increase in risk).
They also found that after one year the high intensity statin treatments produced a 5% relative increase in muscle pain or weakness compared to placebo.
This suggests that not only do high-intensity statin treatments lead to larger risks of muscle symptoms in the first year than moderate-intensity statins, but that there may be a persisting low risk of such symptoms beyond this time.
Study’s findings are ‘reassuring’ for clinicians and patients
The authors acknowledge some limitations to their study including a lack of consistently available data about whether muscle events led to discontinuation of treatment. Additionally, there was no reliable information about some relevant comorbid conditions or other medications that may affect the risk of experiencing symptoms.
Nevertheless, Dr Christina Reith, Senior Clinical Research Fellow at Oxford Population Health and joint lead author of the study said it is important to note that ‘people not on statins also commonly [experience muscle pain], and therefore most of the time, statins will not be the cause.
“We hope that these results will help doctors and patients to make informed decisions about whether to start or remain on statin therapy, bearing in mind its known significant benefits in reducing the risk of cardiovascular disease,” she added.
Professor Martin Marshall, Chair of the Royal College of GPs, said that the study’s findings should be “reassuring to clinicians and patients taking or considering statins”.
“GPs are highly trained to prescribe and will do so based on the circumstances of individual patients. We will take into account a patient’s health needs and their medical history, as well as clinical guidance and we will consider the various treatment options, not just drug therapies, in conversation with the patient about the risks and benefits of each,” he added.