NEJM publishes results of IMPROVE-IT trial of Vytorin in ACS- Merck Inc.

Merck announced that the New England Journal of Medicine published the results of the IMPROVE-IT trial, an investigational study comparing treatment with Vytorin (ezetimibe and simvastatin) to treatment with simvastatin alone in more than 18,000 patients presenting with acute coronary syndromes.The results of IMPROVE-IT were first presented at the American Heart Association Scientific Sessions in November, 2014. In IMPROVE-IT, patients taking the LDL-cholesterol-lowering medicine Vytorin— 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 November 2014, Merck announced IMPROVE-IT met its primary and all secondary composite efficacy endpoints. In IMPROVE-IT, at seven years, 32.7 percent of patients taking Vytorin experienced a first primary endpoint event (major cardiovascular event) compared to 34.7 percent of patients taking simvastatin alone, corresponding to a 6.4% relative risk reduction (absolute risk reduction 2%, hazard ratio of 0.936, 95% CI 0.887 to 0.988, p=0.016). The mean LDL-C in the study at one year was 53 mg/dl in the Vytorin arm and 70 mg/dl in the simvastatin arm.