Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo. Academic Article Article uri icon

Overview

MeSH

  • Aged
  • Cardiovascular Diseases
  • Double-Blind Method
  • Female
  • Glucagon-Like Peptide 1
  • Humans
  • Male
  • Middle Aged
  • Placebos
  • Research Design

MeSH Major

  • Acute Coronary Syndrome
  • Peptides
  • Protein Kinase Inhibitors
  • p38 Mitogen-Activated Protein Kinases

abstract

  • Cardiovascular (CV) disease is the leading cause of morbidity and mortality in patients with type 2 diabetes mellitus (T2DM). Furthermore, patients with T2DM and acute coronary syndrome (ACS) have a particularly high risk of CV events. The glucagon-like peptide 1 receptor agonist, lixisenatide, improves glycemia, but its effects on CV events have not been thoroughly evaluated. ELIXA (www.clinicaltrials.gov no. NCT01147250) is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study of lixisenatide in patients with T2DM and a recent ACS event. The primary aim is to evaluate the effects of lixisenatide on CV morbidity and mortality in a population at high CV risk. The primary efficacy end point is a composite of time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. Data are systematically collected for safety outcomes, including hypoglycemia, pancreatitis, and malignancy. Enrollment began in July 2010 and ended in August 2013; 6,068 patients from 49 countries were randomized. Of these, 69% are men and 75% are white; at baseline, the mean ± SD age was 60.3 ± 9.7 years, body mass index was 30.2 ± 5.7 kg/m(2), and duration of T2DM was 9.3 ± 8.2 years. The qualifying ACS was a myocardial infarction in 83% and unstable angina in 17%. The study will continue until the positive adjudication of the protocol-specified number of primary CV events. ELIXA will be the first trial to report the safety and efficacy of a glucagon-like peptide 1 receptor agonist in people with T2DM and high CV event risk. Copyright © 2015. Published by Elsevier Inc.

authors

publication date

  • May 2015

has subject area

  • Acute Coronary Syndrome
  • Aged
  • Cardiovascular Diseases
  • Double-Blind Method
  • Female
  • Glucagon-Like Peptide 1
  • Humans
  • Male
  • Middle Aged
  • Peptides
  • Placebos
  • Protein Kinase Inhibitors
  • Research Design
  • p38 Mitogen-Activated Protein Kinases

Research

keywords

  • Comparative Study
  • Journal Article
  • Multicenter Study
  • Randomized Controlled Trial

Identity

Language

  • eng

Digital Object Identifier (DOI)

  • 10.1016/j.ahj.2015.02.002

PubMed ID

  • 25965710

Additional Document Info

start page

  • 631

end page

  • 638.e7

volume

  • 169

number

  • 5