The FDA issued an Early Communication regarding its ongoing review of Vytorin (ezetimibe and simvastatin) based on preliminary results from the recently completed ENHANCE (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia) study on this cholesterol-lowering drug.
The agency stated that it will conduct a review of trial data upon receiving the final study results. Merck and Schering Plough Pharmaceuticals issued a press release reporting preliminary ENHANCE results showing no significant differences between the combination product and simvastatin on the build-up of cholesterol plaque in the carotid arteries. Until the FDA reviews the data, it advises patients to discuss any questions they have about the ENHANCE study with their health-care providers.
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