The FDA is evaluating the preliminary outcomes from an ongoing data review of Merck/Schering-Plough’s Vytorin (ezetimibe/simvastatin) and Zetia (ezetimibe), and Merck’s Zocor (simvastatin). The ENHANCE trial conducted by Merck and Schering-Plough was designed to measure amounts of atherosclerotic plaque in carotid arteries in patients treated with Vytorin or Zocor alone. The trial determined there were no significant differences between Vytorin and Zocor in the amount of atherosclerotic plaque in the carotid arteries, despite a greater lowering of LDL-cholesterol with Vytorin.
After the final review of the ENHANCE data, the FDA will consider all other available information linking LDL lowering and reduced cardiovascular events. They will also determine if further regulatory action is warranted with regard to Zetia and Vytorin, and whether any changes to the FDA’s current approach to LDL-cholesterol lowering drugs are warranted.
For more information visit http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin.htm.