Long-Term Outcomes of Evacetrapib on Cardiovascular Outcomes
The trial was terminated early due to lack of efficacy.
HealthDay News — For patients with high-risk vascular disease, evacetrapib does not affect the primary efficacy end point of first occurrence of any component of a composite of death from cardiovascular causes, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina, according to a study published in the New England Journal of Medicine.
A. Michael Lincoff, MD, from the Cleveland Clinic, and colleagues enrolled 12,092 patients with high-risk vascular disease. Participants were randomized to receive evacetrapib or matching placebo daily, as well as standard medical therapy.
The researchers observed a 31.1% decrease in the mean low-density lipoprotein cholesterol level with evacetrapib vs a 6% increase with placebo at 3 months; 133.2% and 1.6% increases were seen in the mean high-density lipoprotein cholesterol levels with evacetrapib and placebo, respectively.
The trial was terminated early due to lack of efficacy after 1363 of the planned 1670 primary end-point events had occurred. A primary end point occurred in 12.9% and 12.8% of patients in the evacetrapib and placebo groups, respectively, after a median of 26 months (hazard ratio, 1.01; 95 percent confidence interval, 0.91 to 1.11; P = 0.91)
"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 write.
Several authors disclosed financial ties to pharmaceutical companies, including Eli Lilly, which manufactures evacetrapib and funded the study.
Lincoff AM, Nicholis SJ, Riesmeyer JS, et al. Evacetrapib and cardiovascular outcomes in high-risk vascular disease. N Engl J Med. 2017 May 18;376(20):1933-1942. doi: 10.1056/NEJMoa1609581.