Ezetimibe/Simvastatin (Vytorin), Ezetimibe (Zetia), and Simvastatin (Zocor) (January 25, 2008)

FDA has announced an ongoing data review for Vytorin, Zetia, and Zocor after Merck/Schering Plough Pharmaceuticals reported preliminary results from the ENHANCE trial comparing the effect of combination ezetimibe and high-dose simvastatin against simvastatin alone on the atherosclerotic process in patients with heterozygous familial hypercholesterolemi. Merck/Shering Plough stated that there was no significant difference between Vytorin or Zocor alone in the amount of atherosclerotic plaque in the innter walls of the carotid arteries. There was, however, a greater lowering of LDL-cholesterol with Vytorin compared to Zocor. After reviewing data from the ENHANCE study, the FDA will determine whether any further regultory action is warranted with regard to Zetia an Vytorin.