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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.

We also agree that it would be ideal to have data on the risk of rhabdomyolysis . . . [Full Text of this Article]

David J. Graham, MD, MPH
grahamd@cder.fda.gov

Judy A. Staffa, PhD; Lois La Grenade, MD, MPH
Office of Drug Safety
US Food and Drug Administration
Rockville, Md

Deborah Shatin, PhD; Stephanie D. Schech, MPH
Center for Health Care Policy and Evaluation
Eden Prairie, Minn

Susan E. Andrade, ScD; Jerry H. Gurwitz, MD
Meyers Primary Care Institute
Worcester, Mass

Michael J. Goodman, PhD
Health Partners Research Foundation
Minneapolis, Minn

K. Arnold Chan, MD, ScD; Richard Platt, MD, MSc
Harvard Medical School
Boston, Mass

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