Positive results for Vytorin in Cardiovascular Risk-Merck

Merck has announced that the investigational IMPROVE-IT study met its primary and all secondary composite efficacy endpoints. In IMPROVE-IT, patients taking the LDL-cholesterol-lowering medicine Vytorin (ezetimibe/simvastatin), which combines simvastatin with the non-statin Zetia (ezetimibe), experienced significantly fewer major cardiovascular events (as measured by a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, re-hospitalization for unstable angina or coronary revascularization occurring at least 30 days after randomization) than patients treated with simvastatin alone. In IMPROVE-IT, at seven years, 32.7 percent of patients taking Vytorin experienced a primary endpoint event compared to 34.7 percent of patients taking simvastatin alone.

Based on the LDL-C range compared in the study�s treatment arms (at one year, a mean LDL-C of 53 mg/dL versus 70 mg/dL, respectively), the 6.4 percent relative risk reduction observed in the Vytorin arm in IMPROVE-IT was consistent with the treatment effect that had been projected based on prior studies of statins. The results from this 18,144-patient study of high-risk patients presenting with acute coronary syndromes were presented during the late-breaking clinical trials session at the American Heart Association 2014 Scientific Sessions.