Study: More CV Events Reduced With Vytorin vs. Statin Alone

Merck announced results from a pre-specified exploratory analysis of an investigational study on ezetimibe/simvastatin (Vytorin) and total cardiovascular events compared to simvastatin alone. The findings were presented at the American College of Cardiology's 64th Annual Scientific Session.

The IMProved Reduction of Outcomes: VYTORIN Efficacy International Trial (IMPROVE-IT) is an international, multi-center, randomized, double-blind active comparator trial of 18,144 high-risk patients presenting with acute coronary syndromes (ACS), including unstable angina (UA), non-ST-segment elevation acute myocardial infarction (NSTEMI), and ST-segment elevation acute myocardial infarction (STEMI). All patients were enrolled within 10 days of ACS hospitalization and had sufficient risk as defined in the protocol and who had an initial LDL-C of ≤125mg/dL if lipid-lowering drug naive or <100mg/dL if on a prior prescription lipid-lowering therapy identified as no more potent than simvastatin 40mg/day. Patients were randomized to receive an initial treatment of ezetimibe/simvastatin 10mg/40mg or simvastatin 40mg with a primary study endpoint of incidence of total cardiovascular (CV) events, as measured by a composite of CV death, non-fatal MI, non-fatal stroke, re-hospitalization for ACS, or coronary revascularization (occurring 30 days or more after the initial event). This included both initial and recurrent events.

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Of the 9.545 initial and recurrent events in the median six-year follow-up, 56% were first events and 44% were subsequent events. Ezetimibe/simvastatin reduced total events by 9% compared to simvastatin alone (incidence-rate ratio [IRR] 0.91, 95% CI 0.85–0.97, P=0.007). This is based on a 6.4% reduction in first events that has been previously reported (HR 0.936 95% CI 0.887–0.988, P=0.016) and a 12% reduction in recurrent events observed in the present analysis (IRR 0.88, 95% CI 0.79–0.98).

Ezetimibe/simvastatin is currently indicated as an adjunct to diet in primary hyperlipidemia (heterozygous familial and non-familial) or mixed hyperlipidemia; to reduce elevated total-C, LDL-C, apo B, TG and non-HDL-C, and to increase HDL-C; as an adjunct to or when other lipid-lowering treatments for homozygous familial hypercholesterolemia (HoFH) are not available; and to reduce elevated total-C and LDL-C.

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