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Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease.

Publication ,  Journal Article
Lincoff, AM; Nicholls, SJ; Riesmeyer, JS; Barter, PJ; Brewer, HB; Fox, KAA; Gibson, CM; Granger, C; Menon, V; Montalescot, G; Rader, D; Li, W ...
Published in: N Engl J Med
May 18, 2017

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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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 18, 2017

Volume

376

Issue

20

Start / End Page

1933 / 1942

Location

United States

Related Subject Headings

  • Treatment Failure
  • Risk
  • Peripheral Vascular Diseases
  • Myocardial Ischemia
  • Middle Aged
  • Male
  • Intracranial Arteriosclerosis
  • Humans
  • General & Internal Medicine
  • Female
 

Citation

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Lincoff, A. M., Nicholls, S. J., Riesmeyer, J. S., Barter, P. J., Brewer, H. B., Fox, K. A. A., … ACCELERATE Investigators, . (2017). Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease. N Engl J Med, 376(20), 1933–1942. https://doi.org/10.1056/NEJMoa1609581
Lincoff, A Michael, Stephen J. Nicholls, Jeffrey S. Riesmeyer, Philip J. Barter, H Bryan Brewer, Keith A. A. Fox, C Michael Gibson, et al. “Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease.N Engl J Med 376, no. 20 (May 18, 2017): 1933–42. https://doi.org/10.1056/NEJMoa1609581.
Lincoff AM, Nicholls SJ, Riesmeyer JS, Barter PJ, Brewer HB, Fox KAA, et al. Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease. N Engl J Med. 2017 May 18;376(20):1933–42.
Lincoff, A. Michael, et al. “Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease.N Engl J Med, vol. 376, no. 20, May 2017, pp. 1933–42. Pubmed, doi:10.1056/NEJMoa1609581.
Lincoff AM, Nicholls SJ, Riesmeyer JS, Barter PJ, Brewer HB, Fox KAA, Gibson CM, Granger C, Menon V, Montalescot G, Rader D, Tall AR, McErlean E, Wolski K, Ruotolo G, Vangerow B, Weerakkody G, Goodman SG, Conde D, McGuire DK, Nicolau JC, Leiva-Pons JL, Pesant Y, Li W, Kandath D, Kouz S, Tahirkheli N, Mason D, Nissen SE, ACCELERATE Investigators. Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease. N Engl J Med. 2017 May 18;376(20):1933–1942.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 18, 2017

Volume

376

Issue

20

Start / End Page

1933 / 1942

Location

United States

Related Subject Headings

  • Treatment Failure
  • Risk
  • Peripheral Vascular Diseases
  • Myocardial Ischemia
  • Middle Aged
  • Male
  • Intracranial Arteriosclerosis
  • Humans
  • General & Internal Medicine
  • Female