Statin and statin-fibrate use was significantly associated with increased myositis risk in a managed care population. J Clin Epidemiol 2007 Aug;60(8):812-8
Date
07/04/2007Pubmed ID
17606177DOI
10.1016/j.jclinepi.2006.11.006Scopus ID
2-s2.0-34347209807 (requires institutional sign-in at Scopus site) 59 CitationsAbstract
OBJECTIVE: We quantified the risk of myositis associated with statin and fibrate drug use with other covariates within a managed care organization (MCO) population.
STUDY DESIGN AND SETTING: The study spanned the years 1999-2003. Myositis cases had creatine kinase (CK) >or=10x upper limit of normal and a myopathy diagnosis. Exposures of statins, fibrates, and other drugs were assessed with age, gender, and indicators of suspected myopathy risk. Exposures were first analyzed within a cohort with CK monitoring and then within a more general secondary cohort. Adjusted relative risks (RRs) and incidence rates of myositis were generated by Poisson regression.
RESULTS: Myositis was significantly associated with statin monotherapy (RR 2.8 [95% confidence interval, CI=1.3-5.9]), statin-fibrate combination therapy (9.1 [95% CI=3.5-23]), comorbid liver disease (4.3 [95% CI=1.5-13], and/or renal disease (2.5 [95% CI=1.3-5.0]). Myositis rates per covariate pattern ranged from 33 to 6,400 per 100,000 person-years. The mean time to event was 1.7 years for statin-fibrate use, 2.0 years for statins alone, and 2.1 years for unexposed. Within the secondary cohort, RRs increased up to 10 times further away from the null.
CONCLUSION: Statins, with or without fibrates, and liver and renal disease were significantly associated with increased myositis risk in an MCO population.
Author List
McClure DL, Valuck RJ, Glanz M, Murphy JR, Hokanson JEAuthor
David L. McClure PhD Adjunct Assistant Professor in the Institute for Health and Equity department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
Age FactorsAged
Clofibric Acid
Cohort Studies
Confidence Intervals
Creatine Kinase
Drug Administration Schedule
Drug Therapy, Combination
Female
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hyperlipidemias
Hypolipidemic Agents
Kidney Diseases
Liver Diseases
Male
Managed Care Programs
Middle Aged
Myositis
Odds Ratio
Proportional Hazards Models
Risk
Risk Assessment
Sex Factors
Time Factors