Risk factors for statin-associated rhabdomyolysis
Meyers Primary Care Institute
Adult; Age Factors; Aged; Aged, 80 and over; Case-Control Studies; Comorbidity; Drug Therapy, Combination; Female; Fenofibrate; Gemfibrozil; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; dosage; Hypolipidemic Agents; Kidney Diseases; Male; Middle Aged; Odds Ratio; Rhabdomyolysis; Risk Factors; Sex Factors
Health Services Research | Primary Care
PURPOSE: To identify and characterize risk factors for rhabdomyolysis in patients prescribed statin monotherapy or statin plus fibrate therapy.
METHODS: A nested case-control study was conducted within a cohort of 252,460 new users of lipid-lowering medications across 11 geographically dispersed U.S. health plans. Twenty-one cases of rhabdomyolysis confirmed by medical record review were compared to 200 individually matched controls without rhabdomyolysis. A conditional logistic regression model was applied to evaluate the effects of age, gender, comorbidities, concurrent medication use, dosage, and duration of statin use on the development of rhabdomyolysis.
RESULTS: Statin users 65 years of age and older have four times the risk of hospitalization for rhabdomyolysis than those under age 65 (odds ratio (OR) = 4.36, 95% confidence interval (CI): 1.5,14.1). We also observed a joint effect of high statin dosage and renal disease (p = 0.022). When these two variables were added to the model with age, we obtained an OR of 5.73 for dosage (95%CI: 0.63, 52.6) and 6.26 for renal disease (95%CI: 0.46, 63.38). Although not statistically significant, we did observe a greater than twofold increase in risk for rhabdomyolysis among females (OR = 2.53, 95%CI: 0.91, 7.32).
CONCLUSIONS: Findings of this study indicate that older age is a risk factor for rhabdomyolysis among statin users. Although the evidence is not as strong, high statin dosage, renal disease, and female gender may be additional risk factors. Patients at higher risk of developing rhabdomyolysis should be closely monitored for signs and symptoms of the disease.
DOI of Published Version
Pharmacoepidemiol Drug Saf. 2007 Mar;16(3):352-8. Link to article on publisher's site
Pharmacoepidemiology and drug safety
Schech, Stephanie D.; Graham, David J.; Staffa, Judy A.; Andrade, Susan E.; La Grenade, Lois; Burgess, Margaret; Blough, David K.; Stergachis, Andy; Chan, K. Arnold; Platt, Richard; and Shatin, Deborah, "Risk factors for statin-associated rhabdomyolysis" (2007). Meyers Primary Care Institute Publications and Presentations. 405.