Letters Section Editor: Robert M. Golub,
MD, Senior Editor.
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.
Graham DJ, Staffa JA, La Grenade L, Shatin D, Schech SD, Andrade SE, Gurwitz JH, Goodman MJ, Chan KA, Platt R. Rhabdomyolysis and Lipid-Lowering Drugs—Reply. JAMA. 2005;293(12):1448-1449. doi:10.1001/jama.293.12.1448-b