Agency to Review Study Data on Cholesterol-Lowering Drug
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.