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March 23/30, 2005

Rhabdomyolysis and Lipid-Lowering Drugs—Reply

Author Affiliations

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2005;293(12):1448-1449. doi:10.1001/jama.293.12.1448-b

In Reply: We agree with Dr Tenenbaum and colleagues regarding the potential effectiveness of the coadministration of a statin and fibrate to patients with mixed lipid disorders. However, the current body of evidence does not allow us to conclude that fenofibrate and bezafibrate have safety profiles that are different from that of gemfibrozil. Although we observed 3 cases of rhabdomyolysis with gemfibrozil monotherapy and 0 cases with fenofibrate monotherapy, the total amount of fenofibrate monotherapy exposure in our study population was only 2529 person-years. The 95% confidence interval for rhabdomyolysis incidence with fenofibrate (0-14.6 cases per 10 000 person-years) completely overlapped with that of gemfibrozil (0.8-10.8 cases per 10 000 person-years), so these incidence rates were statistically indistinguishable. Until larger studies are performed with adequate statistical power, safety conclusions for the class of fibrates are premature.

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