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Vytorin Trial Fails To Meet Endpoint

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Merck and Schering-Plough’s ENHANCE comparator trial for Vytorin did not meet its primary endpoint. The trial examined Vytorin—which combines the companies’ drug Zetia (ezetimibe) with Merck’s Zocor (simvastatin)—against Zocor alone in demonstrating plaque regression and cholesterol lowering, in a set of patients with a rare condition.
   
The ENHANCE trial was conducted in 720 patients with Heterozygous Familial Hypercholesterolemia (HeFH), a rare genetic predisposition to dangerously high cholesterol levels. The primary endpoint was the mean change in the intima-media thickness (IMT) measured at three sites in the carotid arteries between patients treated with ezetimibe/simvastatin 10/80 mg versus patients treated with simvastatin 80 mg alone over a two-year period.
   
There was no statistically significant difference between treatment groups on the primary endpoint. There was also no statistically significant difference between the treatment groups for each of the components of the primary endpoint, including the common carotid artery. In addition, secondary imaging endpoints showed no statistical difference between treatment groups.
   
The overall incidence rates of treatment-related adverse events were generally similar between treatment groups and both medicines were generally well tolerated.

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