FDA on ENHANCE

Executive Summary

The agency will review the recently completed study of the Merck/Schering-Plough combination cholesterol therapy Vytorin after it receives the final results, according to a Jan. 25 announcement. The study found "no statistically significant differences" between a group receiving the highest dose of Vytorin (10 mg ezetimibe plus 80 mg simvastatin) and a group receiving 80 mg simvastatin in either the primary endpoint or in key secondary imaging endpoints (1"The Tan Sheet" Jan. 21, 2008, p. 12). Investigators in the firms' ENHANCE trial determined the primary endpoint - mean change in the intima-media thickness - through ultrasound measurements of the carotid arteries. FDA said it is not clear why the lower levels of LDL cholesterol in patients who took Vytorin did not lead to lesser amounts of plaque, compared to patients treated with simvastatin alone...