The FDA has completed its review of the final clinical study report for Merck/Schering-Plough’s Vytorin
(ezetimibe/simvastatin) and Zetia
(ezetimibe), and Merck’s Zocor
(simvastatin), which were the results from the ENHANCE trial. The trial findings do not change the FDA’s position that elevated LDL-cholesterol is a risk factor for cardiovascular disease and that lowering LDL-cholesterol reduces the risk for cardiovascular disease. The FDA is advising that patients should not stop taking Vytorin or other cholesterol lowering medications.
The ENHANCE trial was designed to measure amounts of atherosclerotic plaque in carotid arteries in patients treated with Vytorin or Zocor alone. The trial concluded 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 compared to simvastatin.
For more information visit www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm109060.htm.