Vytorin ezetimibe/simvastatin: Phase III data

The double-blind, U.K. Phase III SHARP trial in 8,384 evaluable patients showed that once-daily Vytorin met the primary endpoint of significantly reducing the incidence of first major vascular events defined as a composite of non-fatal MI or cardiac death, stroke or any revascularization procedure vs. placebo (15.2% vs. 17.9%, p=0.001). On secondary endpoints, there was no difference between Vytorin and placebo in the proportion of patients who progressed to ESRD (33.9% vs. 34.6%). Additionally, there was no significant difference between treatment groups in the incidence of cancer (9.4% vs. 9.5%, p=0.89) or cancer-related deaths (3.2% vs. 2.8%, p=0.2). Data were presented at the American Society of Nephrology meeting in Denver. ...