Reported muscle pain and weakness often not due to statin therapy: meta-analysis shows.

By Wally A. Omar, MD on

Key Points

  • Statin therapy is in wide use globally to prevent cardiovascular events in patients with elevated cholesterol levels. Despite an abundance of data proving their effect, many patients exhibit caution in starting the therapy due to concerns of muscle pain and weakness.
  • The CTT meta-analysis of 23 trials, spanning over 150,000 patients demonstrated a small increase in the frequency with which muscle weakness and pain were reported in the first year of therapy. This increase did not persist beyond one year.
  • Investigators adjudicated the etiology of muscle pain and weakness in the individual trials, finding that only 1 in 15 reports were truly caused by the statin therapy.

The benefits of statin therapy in preventing heart attacks, strokes and the progression of cardiovascular disease have long been established. Despite this, many patients remain hesitant to initiate the therapy due to concerns of muscle pain and muscle weakness.  In a Hot Line Session today at the 2022 European Society of Cardiology congress, Dr. Colin Baigent demonstrated how these fears may be overblown, by presenting the results of the Cholesterol Treatment Trialists’ metanalysis of statin trials.

The study was a data meta-analysis of all recorded muscle symptoms in large-scale randomized double-blinded trials of stain therapies. The team compiled data from 23 trials within the Cholesterol Treatment Trialists’ Collaboration, with over 155,000 patients enrolled. Each trial had at least 1,000 patients and 2 years of data recorded. The researchers found no significant difference in the frequency with which muscle pains and muscle weakness were reported across the two groups. In the 19 trials comparing statin to placebo, there were more reports of muscle pain or weakness in the statin group (27.1% vs. 26.6%, RR 1.03, 95% CI 1.01-1.06). When split into the first year of therapy and later years, there was a 7% increase in muscle intolerance in the statin group within the first year, corresponding to an absolute excess rate of 11 per 1,000 person-years (95% CI 6-16). This increase tapers off during the follow up period, in which there is no excess risk (RR 0.99; 95% CI 0.96-1.02).

The investigators analyzed the etiology of muscle pains in the first year of reporting, and noted only 1 in 15 cases to be attributable to stain therapy. Dr. Baigent stated that these results should “help doctors and patients to make informed decisions about whether to start or remain on statin therapy,” “adding statins were not the cause of muscle pain in more than 93% of patients who reported symptoms”. He urged that drug labelling and guidelines be reviewed, as they are used by both physicians and patients in making statin-related decisions.