Severity of statin-induced adverse effects on muscle and associated conditions: data from the DAMA study

Expert Opin Drug Saf. 2016 Dec;15(12):1583-1587. doi: 10.1080/14740338.2016.1238068. Epub 2016 Oct 24.


Background: Statins are generally well tolerated, but muscular adverse effects appear to be the most common obstacle limiting their use. Our objective was to describe the severity of muscle injury (myalgia, myositis and rhabdomyolysis) and associated conditions related to statin therapy that may be clinically significant.

Methods: A cross-sectional one-visit, non-interventional, national multicenter study including patients of both sexes over 18 years of age referred for past or present muscle symptoms associated with statin therapy was conducted. Clinical, biochemical and drug therapy characteristics were obtained at the initial evaluation.

Results: 3,845 patients were recruited from a one-day record from 2,001 physicians. Myalgia was present in 78.2% of patients, myositis in 19.3% and rhabdomyolysis in 2.5%. The prevalence of different comorbidities such as diabetes, hypertension, atrial fibrillation, and coronary heart disease increased as the severity of myopathy rose. High-intensity statin therapy was used in 33.4% of patients. Concomitant drugs metabolized by the CYP450 3A4 pathway were taken by 9.3% of patients, and statins with this metabolic route by 75%. Independent variables associated with myositis or rhabdomyolysis compared with myalgia alone in the multivariate model were excessive alcohol consumption and pravastatin therapy.

Conclusion: Myalgia was the most common muscle adverse effect associated with statin therapy. Excessive alcohol consumption and pravastatin were independently associated with myositis or rhabdomyolysis.

Keywords: Adverse effect; myalgia; myopathy; myositis; rhabdomyolysis; statin intolerance.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Cross-Sectional Studies
  • Female
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects*
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Muscular Diseases / chemically induced
  • Muscular Diseases / epidemiology
  • Myalgia / chemically induced*
  • Myalgia / epidemiology
  • Myositis / chemically induced*
  • Myositis / epidemiology
  • Prevalence
  • Rhabdomyolysis / chemically induced*
  • Rhabdomyolysis / epidemiology
  • Risk Factors
  • Severity of Illness Index


  • Hydroxymethylglutaryl-CoA Reductase Inhibitors