Vytorin Yields Mixed Outcomes

Vytorin (simvastatin plus ezetimibe) reduces atherosclerotic events in patients with aortic stenosis — but has no effect on aortic-valve events — researchers reported at a press conference earlier this week.

The industry-funded SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) study randomized nearly 1900 patients with mild-to-moderate aortic stenosis to Vytorin or placebo. During roughly 4 years' follow-up, the primary endpoint — a composite of atherosclerotic and aortic-valve events — did not differ between the groups. In secondary analyses, atherosclerotic events alone were lower with Vytorin than with placebo (16% vs. 20%), but aortic-valve events were not reduced.

Cancer was observed more often with Vytorin than with placebo (10% vs. 7%); however, the researchers note that data from larger studies do "not support the suggestion of an increase in cancer" with the drug.

To date, the SEAS data have not been presented at a meeting or published in a journal.