Vytorin Misses Endpoint in Cardiovascular Outcomes Trial

Merck and Schering-Plough’s troubled cholesterol drug Vytorin hit another snag Monday as results from a clinical trial in Europe found that the drug did not stop the progression of aortic valve disease.

The primary endpoint for SEAS, a cardiovascular outcomes trial, was the incidence of major cardiovascular events, a composite of the study’s two secondary endpoints: events associated with aortic valve disease and atherosclerosis.

Vytorin (ezetimibe/simvastatin) did not have a significant effect on the primary endpoint or the aortic valve disease endpoint, but it showed a statistically significant reduction in atherosclerotic events.

Although the drug was generally well tolerated, 158 subjects had a serious adverse event attributed to cancer, with events in 93 patients on the drug and 65 subjects on placebo. There also were more cancer-related deaths for patients on Vytorin, 39 versus 23, as compared with placebo, according to Terje Pedersen, lead clinical investigator for the study.