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Rationale and design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial.

Publication ,  Journal Article
Holman, RR; Bethel, MA; George, J; Sourij, H; Doran, Z; Keenan, J; Khurmi, NS; Mentz, RJ; Oulhaj, A; Buse, JB; Chan, JC; Iqbal, N; Kundu, S ...
Published in: Am Heart J
April 2016

Exenatide once-weekly is an extended release formulation of exenatide, a glucagon-like peptide-1 receptor agonist, which can improve glycemic control, body weight, blood pressure, and lipid levels in patients with type 2 diabetes mellitus (T2DM). The EXenatide Study of Cardiovascular Event Lowering (EXSCEL) will compare the impact of adding exenatide once-weekly to usual care with usual care alone on major cardiovascular outcomes. EXSCEL is an academically led, phase III/IV, double-blind, pragmatic placebo-controlled, global trial conducted in 35 countries aiming to enrol 14,000 patients with T2DM and a broad range of cardiovascular risk over approximately 5 years. Participants will be randomized (1:1) to receive exenatide once-weekly 2 mg or matching placebo by subcutaneous injections. The trial will continue until 1,360 confirmed primary composite cardiovascular end points, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, have occurred. The primary efficacy hypothesis is that exenatide once-weekly is superior to usual care with respect to the primary composite cardiovascular end point. EXSCEL is powered to detect a 15% relative risk reduction in the exenatide once-weekly group, with 85% power and a 2-sided 5% alpha. The primary safety hypothesis is that exenatide once-weekly is noninferior to usual care with respect to the primary cardiovascular composite end point. Noninferiority will be concluded if the upper limit of the CI is <1.30. EXSCEL will assess whether exenatide once-weekly can reduce cardiovascular events in patients with T2DM with a broad range of cardiovascular risk. It will also provide long-term safety information on exenatide once-weekly in people with T2DM. ClinicalTrials.gov Identifier: NCT01144338.

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Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

April 2016

Volume

174

Start / End Page

103 / 110

Location

United States

Related Subject Headings

  • Venoms
  • United States
  • United Kingdom
  • Time Factors
  • Survival Rate
  • Risk Factors
  • Risk Assessment
  • Prognosis
  • Peptides
  • Ontario
 

Citation

APA
Chicago
ICMJE
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Holman, R. R., Bethel, M. A., George, J., Sourij, H., Doran, Z., Keenan, J., … Hernandez, A. F. (2016). Rationale and design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial. Am Heart J, 174, 103–110. https://doi.org/10.1016/j.ahj.2015.12.009
Holman, Rury R., Mary Angelyn Bethel, Jyothis George, Harald Sourij, Zoë Doran, Joanne Keenan, Nardev S. Khurmi, et al. “Rationale and design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial.Am Heart J 174 (April 2016): 103–10. https://doi.org/10.1016/j.ahj.2015.12.009.
Holman RR, Bethel MA, George J, Sourij H, Doran Z, Keenan J, et al. Rationale and design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial. Am Heart J. 2016 Apr;174:103–10.
Holman, Rury R., et al. “Rationale and design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial.Am Heart J, vol. 174, Apr. 2016, pp. 103–10. Pubmed, doi:10.1016/j.ahj.2015.12.009.
Holman RR, Bethel MA, George J, Sourij H, Doran Z, Keenan J, Khurmi NS, Mentz RJ, Oulhaj A, Buse JB, Chan JC, Iqbal N, Kundu S, Maggioni AP, Marso SP, Öhman P, Pencina MJ, Poulter N, Porter LE, Ramachandran A, Zinman B, Hernandez AF. Rationale and design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial. Am Heart J. 2016 Apr;174:103–110.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

April 2016

Volume

174

Start / End Page

103 / 110

Location

United States

Related Subject Headings

  • Venoms
  • United States
  • United Kingdom
  • Time Factors
  • Survival Rate
  • Risk Factors
  • Risk Assessment
  • Prognosis
  • Peptides
  • Ontario