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Ezetimibe, a novel cholesterol-absorption inhibitor marketed in the U.S. since October 2002, lowers LDL cholesterol levels. However, little is known about its effect on atherosclerosis progression. In the ENHANCE trial, 720 patients with familial hypercholesterolemia were randomized to a daily regimen of simvastatin (80 mg) plus either ezetimibe (10 mg) or placebo. The primary endpoint was the mean change in carotid-artery intima–media thickness. The study was sponsored and administered by the manufacturers and completed in April 2006. On January 14, 2008, the sponsor released some information about the trial; the present analysis is of the complete data set.
The mean age of the patients was 46; 80% had previously taken statins. At 24 months…