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Abstract Title:

Statin-associated rhabdomyolysis: is there a dose-response relationship?

Abstract Source:

Can J Cardiol. 2011 Mar-Apr;27(2):146-51. PMID: 21459261

Abstract Author(s):

Anne Holbrook, Mitchell Wright, Melani Sung, Christine Ribic, Steven Baker

Article Affiliation:

Division of Clinical Pharmacology and Therapeutics, McMaster University, Hamilton, Ontario, Canada. holbrook@mcmaster.ca

Abstract:

BACKGROUND: Statins have a well-established role in prevention of vascular events but are associated with muscle-related adverse events. The dose relationship with these adverse events is unclear. We present an original analysis of Canadian and US case reports of statin-associated rhabdomyolysis with a focus on dose response. A typical clinical case is also summarized.

METHODS: All cases of statin-associated rhabdomyolysis reported to Health Canada's Canadian Vigilance Program and to the US Food and Drug Administration's Adverse Event Reporting System from 2004-2008 were analyzed by severity and dose equivalence. Canadian national statin utilization data from 2002-2007 were used to estimate the dose-related incidence of rhabdomyolysis corrected for levels of utilization.

RESULTS: The clinical case illustrates well the potential severity of statin-induced rhabdomyolysis. Combined Canadian/US data revealed an average of 812 cases of statin-induced rhabdomyolysis reported annually with a mean patient age of 64.4 years (35.5% female). The worst outcomes reported were renal dysfunction in 17.0%, acute renal failure in 19.8%, dialysis in 5.2%, and death in 7.6%. Using 10 mg atorvastatin per day as the reference dose, the odds ratios of rhabdomyolysis were 3.8 (95% CI 2.3-6.6) for 40 mg/day atorvastatin dose equivalent and 11.3 (95% CI 6.4-20.4) for 80 mg/day atorvastatin dose equivalent.

CONCLUSIONS: The results of our adverse drug analysis suggest a dose-response relationship. Given the widespread use of statins, the ability to predict which patients will experience serious muscle-related harm is a research priority.

Study Type : Human Study

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