Is combined treatment with fenofibrate and ezetimibe safe and efficacious in patients with mixed hyperlipidemia?
Michael H Davidson
Correspondence Radiant Research, 515 North State Street, Suite 2700, Chicago, IL 60610, USA
Email michaeldavidson@radiantresearch.com
This article has no abstract so we have provided the first paragraph of the full text.
Ezetimibe, a novel cholesterol absorption inhibitor, has become a well-recognized therapy for lowering LDL cholesterol, most commonly in combination with a statin. By lowering LDL cholesterol by a further 18% over statin alone, ezetimibe treatment results in LDL cholesterol reductions comparable to that of triple the statin dose and has, therefore, become a very useful treatment to achieve National Cholesterol Education Program Adult Treatment Panel III goals in high-risk patients. When ezetimibe first became available, the combination with fibrate was not advised because of the lack of data from large safety and efficacy trials, and the evidence from pharmacokinetic trials demonstrating that fibrates increased the bioavailability of ezetimibe, resulting in higher plasma levels.1 In addition, fibrates are known to increase cholelithiasis, and a dog model found that ezetimibe increased the cholesterol content of bile, thereby theoretically increasing the risk of gallstones.2 Higher blood levels of ezetimibe were not believed to be a safety issue because in dose-ranging trials doses above 10 mg were not associated with additional adverse effects. An initial 12-week placebo-controlled trial3 comparing ezetimibe and fenofibrate combined or alone demonstrated the added efficacy of coadministered ezetimibe and fenofibrate compared with the monotherapy of each treatment, but since the trial only lasted 12 weeks, long-term safety, especially in reference to liver abnormalities or gallbladder disease, could not be established. This 48-week trial by McKenney et al. has confirmed the sustained efficacy of the combined therapy shown in the 12-week trial and established that there are no significant adverse effects associated with a combination of ezetimibe and a fibrate compared with fibrate alone.
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