Statin myalgia has been called out as largely “fake news” as the evidence is now irrefutable that statins are rarely associated with muscle pain or weakness.
An individual participant data meta-analysis of all recorded adverse muscle events in 23 RCTs of statin therapy has shown less than 10% of muscle symptoms were attributed to the drugs.
The study was published in The Lancet and concurrently presented at the ESC Congress 2022 in Barcelona.
The meta-analysis of data from 155,000 patients found statin therapy produced a 7% relative increase in muscle pain or weakness during the first year (RR 1·07), but no significant increase thereafter (RR 0·99).
The absolute excess rate of muscle pain or weakness was 11 per 1000 person-years in the first year and 0 per 1000 person-years in subsequent years.
“Approximately 1 in 15 … reports of muscle symptoms (<10% of reports) during the first year were attributable to statin therapy,” the article said.
The meta-analysis found no evidence that the RRs varied significantly among different statins.
“When categorised by statin intensity, less intensive and moderate-intensity regimens yielded a 3% relative increase in the rate of first reports of muscle pain or weakness (RR 1·03; 95% CI 1·00–1·05) with a 6% increase in the first year (1·06; 1·03–1·10) but no increase thereafter (0·98; 0·95–1·02).”
It found similar excesses of risk in different types of muscle symptoms – myalgia, muscle cramps or spasm, limb pain, other musculoskeletal pain, or muscle fatigue or weakness – and that the severity of muscle symptoms caused by statins was no worse than symptoms not caused by a statin.
The authors, from the Cholesterol Treatment Trialists Collaboration, said any excess risk of muscle symptoms was greatly outweighed by the known cardiovascular benefits of statin therapy.
“Our findings suggest that there is a need to review recommended strategies for managing such symptoms, and to revise the information in the drug label for statins,” they said.
“In particular, for patients who report mild muscle symptoms when taking a statin, our findings suggest that it is most likely that the symptoms are not due to the statin, and statin therapy should continue until other potential causes have been explored.
A linked Comment in The Lancet said the problem of statin intolerance in 2022 was not a problem of evidence but of education.
“Physicians, scientific societies, and governments have allowed the development of a vocal anti-statin movement that has resulted in 7–10 times more so-called fake news on the internet than reliable reports on the harmful role of low-density lipoprotein cholesterol and the benefits of statin therapy.”
“There is an urgent need for collaboration between all stakeholders to produce effective educational campaigns for patients and the public (beginning with the school curriculum) and to continuously educate other physicians.”
“Without such action, the current situation will not improve, and only a quarter or a third of patients will reach their low-density lipoprotein cholesterol target, and lipid disorders will be the most common and the worst-controlled cardiovascular disease risk factor.”