While statin therapy caused a small proportional increase in reports of muscle pain, primarily in the first year of treatment, "the small risks of muscle symptoms are much lower than the known cardiovascular benefits," according to researchers presenting the findings of a large-scale meta-­analysis of more than 20 randomized statin therapy trials as part of ESC Congress 2022 in Barcelona, and simultaneously published in The Lancet.

The findings were based on an analysis of individual participant data included in 23 double-blinded statin therapy trials of at least 1,000 participants conducted between January 1990 and June 2021. All trials had a scheduled treatment duration of at least two years and compared either statin therapy vs. placebo (n=123,940) or more-intensive vs. less-intensive statin treatment strategies (n=30,724). Researchers conducted standard inverse-variance-weighted meta-analyses of the effects on muscle outcomes according to a prespecified protocol.

Overall results found statin regimens caused a small, 3% relative increase in the number of first reports of muscle symptoms, but the majority of reports largely occurred during the first year of treatment (absolute excess rate of 11 events per 1,000 person-years). Most (>90%) of all reports of muscle symptoms by participants allocated statin therapy were not due to the statin, said Colin Baigent, MD, who presented the findings. In addition, most reported increases in symptoms (and in the duration of symptoms) were greater in individuals on more intensive statin regimens compared with those on less intensive therapy.

In addition, researchers said the "relative increase in the rate of muscle symptoms was similar in a wide range of trial participants and was irrespective of the variation in the methods used to ascertain symptoms, suggesting that the observed relative effects of statins on muscle symptoms are likely to be generalizable."

Baigent, et al., noted that the availability of individual participant data was one of the major benefits of the trial, permitting more "detailed analyses of risk for each statin than have previously been possible, including analyses examining the effects on particular symptoms, the timing of any excess risk, and the variation in treatment effects in different types of patients." Based on these findings, they suggest a clear need to both review the clinical management of muscle symptoms in patients taking statins and to revise drug label information. "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," they write.

Clinical Topics: Dyslipidemia, Nonstatins, Novel Agents, Statins

Keywords: ESC Congress, ESC22, ACC International, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Myalgia, Muscles

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