Experimental Cholesterol Drug Found Ineffective

Evacetrapib, a cholesterol-lowering drug, did not reduce the rate of cardiovascular events in patients with high-risk vascular disease, according to the findings of a new study.

The multicenter, randomized, double-blind, placebo-controlled phase 3 trial included 12,092 patients randomly assigned to receive either a daily 130 mg dose of evacetrapib or matching placebo in addition to standard therapy. Patients selected for the study either had acute coronary syndrome, cerebrovascular atherosclerotic disease, peripheral vascular arterial disease, or diabetes with coronary artery disease. The first occurrence of myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina, or cardiovascular-related death was used as the primary end-point.
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After 3 months, the mean LDL cholesterol levels in patients who received evacetrapib decreased by 31.1%, and increased  by 6% in patients who received placebo. The mean HDL levels increased by 133.2% in patients who received evacetrapib and increased by 1.6% in patients who received the placebo.

The trial was terminated early due to lack of efficacy after 1363 of the planned 1670 primary end-point events occurred. A primary end-point event occurred in 12.9% of patients who received evacetrapib compared with 12.8% of patients who received the placebo after a median of 26 months.

“Although the cholesteryl ester transfer protein inhibitor evacetrapib had favorable effects on established lipid biomarkers, treatment with evacetrapib did not result in a lower rate of cardiovascular events than placebo among patients with high-risk vascular disease,” the researchers concluded.

—Melissa Weiss

Reference:

Lincoff AM, Nicholls SJ, Riesmeyer JS, et al. Evacetrapib and cardiovascular outcomes in high-risk vascular disease [published online May 18, 2017]. N Engl J Med. doi:10.1056/NEJMoa1609581.