Breaking News: A Disappointment for Zetia

January 15, 2008

zetia.jpgCommentary by Alana Choy-Shan MD, NYU Chief Resident

The highly anticipated results of the ENHANCE trial will likely be presented at the American College of Cardiology meeting in March, but the preliminary results already have everyone talking. ENHANCE was a multinational, double-blind randomized controlled trial sponsored by Merck and Schering-Plough (the manufacturers of the combination ezetimibe/simvastatin pill). A total of 720 patients who were heterozygotes for Familial Hypercholesterolemia were randomized to treatment with either ezetimibe/simvastatin 10/80mg or simvastatin 80mg. The primary endpoint was change in mean carotid intima-media thickness (IMT) after two years of treatment. Combination therapy resulted in a change in mean carotid IMT of 0.0111mm versus 0.0058mm with simvastatin alone (p=0.29). LDL levels, which at baseline were approximately 320mg/dL in the two groups, were lowered by 58% with ezetimibe/simvastatin and 41% with simvastatin (p<0.01). Based on these results, the addition of ezetimibe to high dose simvastatin appears to improve LDL levels without a concordant impact on carotid IMT in this population. Though the carotid IMT results are not statistically significant and the study population was a particularly high risk group by virtue of their genetic make-up, the lay press is already reporting that ezetimibe fails to slow atherosclerosis and may actually promote it. Not surprisingly, Merck and Schering-Plough share prices have already fallen – probably not quite the ENHANCEment they were hoping for…

NY Times Link

Schering-Plough Release