Study Halted After Mixed Results with Investigational Cholesterol Drug
Researchers from the Cleveland Clinic have found that treatment with evacetrapib in the ACCELERATE study failed to reduce the rates of major cardiovascular events, including heart attack, stroke, angina or cardiovascular death, despite a reduction in the levels of low-density lipoprotein (LDL) by 37% and an increase in the levels of high-density lipoprotein (HDL) by 130%. Study findings are being presented at the American College of Cardiology's 65th Annual Scientific Session.
The ACCELERATE study is a multicenter, randomized, placebo-controlled Phase 3 trial evaluating evacetrapib 130mg daily vs. placebo, along with standard treatment, in more than 12,000 patients at high risk for serious cardiovascular events. Study participants either had an acute coronary syndrome 30 days to one year before enrolling, had cerebrovascular atherosclerotic disease, had peripheral vascular disease, or had both diabetes and coronary artery disease.
Study results showed that patients treated with evacetrapib had a reduction in their LDL level by 37% and an increase in their HDL level by 130%. Despite the favorable effects on LDL and HDL levels, no reduction in the occurrence of cardiovascular death, heart attack, stroke, coronary artery bypass surgery or hospitalization for chest pain due to unstable angina were seen. Researchers observed a borderline significant reduction in all-cause mortality in evacetrapib-treated patients, however, it was not driven by a decrease in cardiovascular death.
The ACCELERATE study was terminated in October 2015 on the recommendation of the independent Data Monitoring Committee after preliminary data suggested the study would not meet its primary endpoint of a reduction in major cardiovascular events.
Evacetrapib is a cholesteryl ester transfer protein (CETP) inhibitor. It works by disrupting the process which normally transfers cholesterol from HDL cholesterol to LDL cholesterol in the body.
For more information visit Clevelandclinic.org.