Risk of hospitalized rhabdomyolysis associated with lipid-lowering drugs in a real-world clinical setting

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• 作者：Mark J. Cziraky ; PharmD ; FAHA ; FNLA^a ; ^{mcziraky@healthcore.com} ; Vincent J. Willey ; PharmD^a ; James M. McKenney ; PharmD ; FAHA ; FNLA^b ; Siddhesh A. Kamat ; MS^a ; Maxine D. Fisher ; PhD^a ; John R. Guyton ; MD ; FNLA^c ; Terry A. Jacobson ; MD ; FACC ; FNLA^d ; Michael H. Davidson ; MD ; FNLA^e
• 关键词：Health policy ; Lipids ; Outcomes research ; Rhabdomyolysis ; Statin therapy
• 刊名：Journal of Clinical Lipidology
• 出版年：2013
• 出版时间：March-April, 2013
• 年：2013
• 卷：7
• 期：2
• 页码：102-108
• 全文大小：133 K

文摘

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Background

The occurrence of low rates of rhabdomyolysis among patients receiving lipid-lowering drugs (LLDs) in randomized clinical trials may be elucidated with population-based studies.

Objective

To determine the risk of hospitalized rhabdomyolysis associated with LLD therapy.

Methods

This observational study used claims data from 9 million members of five United States health plans to identify patients (¡Ý18 years) who received >2 statin and nonstatin LLDs during July 2000 to December 2004. Inpatient International Classification of Diseases, Ninth Revision, Clinical Modification, codes for rhabdomyolysis (791.3, 728.89, and 728.88) were observed during the follow-up period; cases were confirmed with patients' medical records. Rhabdomyolysis events were reported per 10,000 person-years of LLD exposure; multivariate analysis was conducted.

Results

The study cohort (N?= 473,343) received 490,988 and 11,624 person-years of LLD, and?combination therapy, respectively. Medical charts were obtained for 104 of 144 eligible patients with rhabdomyolysis claims; 42 cases were confirmed. With atorvastatin as reference, rhabdomyolysis rates (95 % confidence interval) were greatest for cerivastatin, 8.4 (2.3-21.7); no difference among available statins was observed. Rates for other LLD monotherapies were: niacin, 2.1 (0.3?7.7), ezetimibe, 2.1 (0.3?7.8), fenofibrate, 0 (0?1.7), and gemfibrozil, 2.0 (0.5?5.2). Multivariate analysis showed only cerivastatin with a significantly greater risk of rhabdomyolysis (odds ratio 4.74, 95 % confidence interval 1.1-21.2, P?= .041) versus atorvastatin among the statins. Combination therapies had increased rhabdomyolysis risk (OR 7.1, 1.6-31.6, P?= .010) versus LLDs alone.

Conclusion

The risk of habdomyolysis among hospitalized patients receiving statins was low; no difference among the available statins was evident. Further data are needed to establish the risk profile but current findings already offer guidance to physicians.