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Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease
A Michael Lincoff1, Stephen J Nicholls1, Jeffrey S Riesmeyer1
1From the Cleveland Clinic Coordinating Center for Clinical Research (C5Research), Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland (A.M.L., V.M., E.M., K.W., D.M., S.E.N.); South Australian Heart and Medical Research Institute, University of Adelaide, Adelaide (S.J.N.), and School of Medical Sciences, University of New South Wales, Sydney (P.J.B.) - both in Australia; Eli Lilly, Indianapolis (J.S.R., G.R., B.V., G.W.); Washington Cardiovascular Associates, Medstar Research Institute, Washington, DC (H.B.B.); Centre for Cardiovascular Science, University of Edinburgh, Edinburgh (K.A.A.F.); Beth Israel Deaconess Medical Center, Boston (C.M.G.); Duke University Medical Center, Durham, NC (C.G.); Université Sorbonne Paris 6, ACTION Study Group, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Institut de Cardiologie, Paris (G.M.); Penn Heart and Vascular Center, Philadelphia (D.R.); Columbia University, New York (A.R.T.), and Saratoga Cardiology Associates, Saratoga Springs (D.K.) - both in New York; St. Michael's Hospital, Toronto (S.G.), Recherche Médicale Saint-Jérôme, Saint-Jérôme, QC (Y.P.), and Centre de Santé et de Services Sociaux du Nord de Lanaudière-Centre Hospitalier Régional de Lanaud, Saint-Charles-Borromée, QC (S.K.) - all in Canada; Instituto Cardiovascular de Buenos Aires, Buenos Aires (D.C.); University of Texas Southwestern Medical Center, Dallas (D.K.M.); Heart Institute (InCor)-University of São Paulo Medical School, São Paulo (J.C.N.); Hospital Central Dr. Ignacio Morones Prieto, San Luis Potosi, Mexico (J.L.L.-P.); the First Affiliated Hospital of Harbin Medical University, Harbin, China (W.L.); and South Oklahoma Heart Research, Oklahoma City (N.T.).
Background:
The cholesteryl ester transfer protein inhibitor evacetrapib substantially raises the high-density lipoprotein (HDL) cholesterol level, reduces the low-density lipoprotein (LDL) cholesterol level, and enhances cellular cholesterol efflux capacity. We sought to determine the effect of evacetrapib on major adverse cardiovascular outcomes in patients with high-risk vascular disease.
Methods:
In a multicenter, randomized, double-blind, placebo-controlled phase 3 trial, we enrolled 12,092 patients who had at least one of the following conditions: an acute coronary syndrome within the previous 30 to 365 days, cerebrovascular atherosclerotic disease, peripheral vascular arterial disease, or diabetes mellitus with coronary artery disease. Patients were randomly assigned to receive either evacetrapib at a dose of 130 mg or matching placebo, administered daily, in addition to standard medical therapy. The primary efficacy end point was the first occurrence of any component of the composite of death from cardiovascular causes, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina.
Results:
At 3 months, a 31.1% decrease in the mean LDL cholesterol level was observed with evacetrapib versus a 6.0% increase with placebo, and a 133.2% increase in the mean HDL cholesterol level was seen with evacetrapib versus a 1.6% increase with placebo. After 1363 of the planned 1670 primary end-point events had occurred, the data and safety monitoring board recommended that the trial be terminated early because of a lack of efficacy. After a median of 26 months of evacetrapib or placebo, a primary end-point event occurred in 12.9% of the patients in the evacetrapib group and in 12.8% of those in the placebo group (hazard ratio, 1.01; 95% confidence interval, 0.91 to 1.11; P=0.91).
Conclusions:
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. (Funded by Eli Lilly; ACCELERATE ClinicalTrials.gov number, NCT01687998 .).
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