Risk factors for statin-associated rhabdomyolysis.
OBJECTIVE
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.
Schech
Stephanie
S
Center for Health Care Policy and Evaluation, Eden Prairie, MN 55344, USA. stephanie_d_schech@uhc.com
Graham
David
D
Staffa
Judy
J
Andrade
Susan E
SE
La Grenade
Lois
L
Burgess
Margaret
M
Blough
David
D
Stergachis
Andy
A
Chan
K Arnold
KA
Platt
Richard
R
Shatin
Deborah
D
D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D016022:Case-Control Studies; D015897:Comorbidity; D004359:Drug Therapy, Combination; D005260:Female; D011345:Fenofibrate / Q000009:adverse effects*; D015248:Gemfibrozil / Q000009:adverse effects*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D000960:Hypolipidemic Agents / Q000009:adverse effects*; D007674:Kidney Diseases / Q000150:complications; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D012206:Rhabdomyolysis / Q000139:chemically induced*; D012307:Risk Factors; D012737:Sex Factors
D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000960:Hypolipidemic Agents; D015248:Gemfibrozil; D011345:Fenofibrate