Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease
Title: Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease
Lincoff, A.M. et al.
What You Need to Know:
In patients with high-risk vascular disease, evacetrapib, a cholesteryl ester transfer protein inhibitor, was found to have a positive effect on lipid biomarkers, however did not lower the rate of cardiovascular events compared to placebo.
- Multicenter, randomized, double-blind, placebo-controlled phase 3 study evaluated 12,092 patients with high-risk vascular disease to determine the effect of evacetrapib on major adverse cardiovascular outcomes
- Included patients with an acute coronary syndrome within the last 30-365 days, cerebrovascular atherosclerotic disease, peripheral vascular arterial disease, or diabetes mellitus with coronary artery disease
- Study groups received 130mg evacetrapib or placebo daily, in addition to standard therapy
- Primary endpoint: “first occurrence of any component of the composite of death from cardiovascular causes, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina”
- At 3 months, mean LDL cholesterol levels decreased by 31.1% in the evacetrapib group and increased by 6.0% increase in the placebo group
- At 3 months, mean HDL cholesterol levels increased by 133.2% in the evacetrapib group and by 1.6% in the placebo group
- Study terminated due to lack of efficacy after 1363 of the 1670 planned primary endpoints occurred
- Primary endpoint occurred in 12.9% of evacetrapib patients vs 12.8% of placebo patients after a median of 26 months of therapy (HR 1.01; 95% CI: 0.91, 1.11; P=0.91)