Evaluation of Lixisenatide in Acute Coronary Syndrome - ELIXA

Dec 03, 2015
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Sanofi
Date Presented:
08/31/2015
Date Published:
12/03/2015
Original Posted Date:
12/03/2015
References

Description:

The goal of the trial was to evaluate treatment with the glucagon-like peptide 1 (GLP-1) receptor agonist lixisenatide compared to placebo among subjects with type 2 diabetes and prior acute coronary syndrome. GLP-1 receptor agonists are glucose-lowering medications, of which some have been associated with increased risk for adverse cardiovascular events.

Contribution to the Literature: The ELIXA trial demonstrated cardiovascular safety for the glucose-lowering medication lixisenatide among high-risk diabetics.

Study Design

  • Randomized
  • Parallel
  • Placebo
  • Double-blind

Subjects with type 2 diabetes and prior acute coronary syndrome were randomized to daily injection of lixisenatide versus placebo.

Inclusion criteria:

  • Type 2 diabetes and recent acute coronary syndrome
  • Total number of enrollees: 6,068
  • Duration of follow-up: median 25 months
  • Mean patient age: 60.3 years
  • Percentage diabetics: 100%

Exclusion criteria:

  • Age <30 years
  • Percutaneous coronary intervention within previous 15 days
  • Coronary artery bypass grafting for the qualifying event
  • Planned coronary revascularization within the next 90 days
  • Estimated glomerular filtration rate <30
  • Glycated hemoglobin <5.5% or >11%
  • Inability to provide written informed consent

Principal Findings:

The primary outcome of cardiovascular death, myocardial infarction, stroke, or hospitalization for unstable angina occurred in 13.4% of the lixisenatide group versus 13.2% of the placebo group (p for noninferiority < 0.001; p for superiority = 0.81). Findings were similar in those with a history of heart failure.

  • Modest weight gain benefit favoring lixisenatide: -0.6 kg with lixisenatide vs. -0.0 kg for placebo (p < 0.001)
  • Hospitalization for heart failure: 4.2% vs. 4.0%

Interpretation:

Among patients with type 2 diabetes and prior acute coronary syndrome, lixisenatide was noninferior to placebo. While this agent failed to demonstrate superiority compared with placebo, in this study, cardiovascular safety for this agent was established. This agent was neutral with regard to hospitalization for heart failure.

References:

Pfeffer MA, Claggett B, Diaz R, et al.,  on behalf of the ELIXA Investigators. Lixisenatide in Patients With Type 2 Diabetes and Acute Coronary Syndromes. N Engl J Med 2015;373:2247-57.

Presented by Dr. Eldrin Lewis at the European Society of Cardiology Congress, London, August 31, 2015.

Keywords: Acute Coronary Syndrome, Angina, Unstable, Diabetes Mellitus, Type 2, Metabolic Syndrome, Glucagon-Like Peptide 1, Myocardial Infarction, Peptides, Receptors, Glucagon, Secondary Prevention, Stroke, Weight Gain, ESC Congress


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