A systematic review of statin-induced muscle problems in clinical trials

source extracted confidence: high 2026-04-09
#cardiovascular-diseases #controlled-clinical-trials-as-topic #humans #hydroxymethylglutaryl-coa-reductase-inhibitors #muscle-skeletal

A systematic review of statin-induced muscle problems in clinical trials

Ganga et al., 2014 | Am Heart J | Systematic Review

Citation

Ganga Harsha V, Slim Hanna B, Thompson Paul D. A systematic review of statin-induced muscle problems in clinical trials. Am Heart J. 2014-Jul;168(1):6-15. doi:10.1016/j.ahj.2014.03.019

Abstract

Statin therapy is associated with muscle problems in approximately 10% to 25% of patients treated in clinical practice, but muscle problems have rarely been reported in controlled clinical trials. We performed a systematic search and review of statin clinical trials to examine how these studies evaluated muscle problems and to determine why there are apparent differences in muscle problems between clinical trials and practice. We initially identified 1,012 reports related to clinical trials of statin therapy, 42 of which qualified for analysis. Fifteen, 4, and 22 trials reported creatine kinase values only >10, 5, and 3 times the upper limits of normal, respectively, in both statin- and placebo-treated participants. Four trials reported average creatine kinase values, which increased with statin treatment in 3 instances. Twenty-six trials reported muscle problems, with an average incidence in statin- and placebo-treated participants of 13%, but only one trial specifically queried about muscle problems. Three trials used a run-in period to eliminate participants with statin intolerance and noncompliance. The percentage of muscle problems tended to be higher with statin treatment (12.7%) than with placebo group (12.4%, P = .06). This small difference probably reflects a high background rate of nonspecific muscle problems in both groups that could not be distinguished from statin-associated myalgia because most clinical trials did not use a standard definition for statin myalgia.

Key Findings

This small difference probably reflects a high background rate of nonspecific muscle problems in both groups that could not be distinguished from statin-associated myalgia because most clinical trials did not use a standard definition for statin myalgia.

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population See abstract
Sample Size 22
Age Range See abstract
Condition See abstract

MeSH Terms

  • Cardiovascular Diseases
  • Controlled Clinical Trials as Topic
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Muscle, Skeletal
  • Muscular Diseases

Evidence Classification

  • Level: Systematic Review
  • Publication Types: Journal Article, Research Support, Non-U.S. Gov't, Systematic Review
  • Vertical: creatine

Provenance

Source extracted via PubMed E-utilities API on 2026-04-09