1. Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome
- Author
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YAN CARLOS DUARTE VERA, Lars Kober, Thomas Pieber, Cafer Zorkun, Ponnusamy Saravanan, Cristian Podoleanu, Andrzej Lubiński, Aldo Pietro Maggioni, Francisco Marin, Yusuf Bozkuş, Martin Gibson, Bertrand Cariou, Anna Vittoria Ciardullo, Neslihan Bascil Tutuncu, Vladimir Rafalskiy, Vladimir Zadionchenko, John Mcmurray, Paramesh S, Fernando Lanas, Veronique Kerlan, Jose Sgarbi, Hertzel Gerstein, Fernando Manzur, SONIA GAZTAMBIDE, Alan Jaap, Pfeffer MA, Claggett B, Diaz R, Dickstein K, Gerstein HC, Køber LV, Lawson FC, Ping L, Wei X, Lewis EF, Maggioni AP, McMurray JJ, Probstfield JL, Riddle MC, Solomon SD, Tardif JC, ELIXA Investigators., Giordano, C., Pfeffer, Ma, Claggett, B, Diaz, R, Dickstein, K, Gerstein, Hc, Køber, Lv, Lawson, Fc, Ping, L, Wei, X, Lewis, Ef, Maggioni, Ap, Mcmurray, Jj, Probstfield, Jl, Riddle, Mc, Solomon, Sd, Tardif, Jc, Rivellese, ANGELA ALBAROSA, University of Zurich, and Pfeffer, Marc A
- Subjects
Male ,Myocardial Infarction ,Kaplan-Meier Estimate ,2700 General Medicine ,Type 2 diabetes ,Angina ,chemistry.chemical_compound ,Treatment Failure ,Myocardial infarction ,Research Support, Non-U.S. Gov't ,Hemoglobin A ,General Medicine ,Middle Aged ,Multicenter Study ,Cardiovascular Diseases ,Randomized Controlled Trial ,Cardiology ,Female ,lixisenatide ,Type 2 ,medicine.medical_specialty ,Acute coronary syndrome ,Glycosylated ,610 Medicine & health ,Unstable ,Glucagon-Like Peptide-1 Receptor ,11171 Cardiocentro Ticino ,Lixisenatide ,Acute Coronary Syndrome ,Aged ,Angina, Unstable ,Diabetes Mellitus, Type 2 ,Hemoglobin A, Glycosylated ,Humans ,Hypoglycemic Agents ,Peptides ,Proportional Hazards Models ,Internal medicine ,Journal Article ,Diabetes Mellitus ,medicine ,Unstable angina ,business.industry ,Semaglutide ,ta3121 ,medicine.disease ,chemistry ,Myocardial infarction complications ,business - Abstract
BACKGROUND: Cardiovascular morbidity and mortality are higher among patients with type 2 diabetes, particularly those with concomitant cardiovascular diseases, than in most other populations. We assessed the effects of lixisenatide, a glucagon-like peptide 1-receptor agonist, on cardiovascular outcomes in patients with type 2 diabetes who had had a recent acute coronary event.METHODS: We randomly assigned patients with type 2 diabetes who had had a myocardial infarction or who had been hospitalized for unstable angina within the previous 180 days to receive lixisenatide or placebo in addition to locally determined standards of care. The trial was designed with adequate statistical power to assess whether lixisenatide was noninferior as well as superior to placebo, as defined by an upper boundary of the 95% confidence interval for the hazard ratio of less than 1.3 and 1.0, respectively, for the primary composite end point of cardiovascular death, myocardial infarction, stroke, or hospitalization for unstable angina.RESULTS: The 6068 patients who underwent randomization were followed for a median of 25 months. A primary end-point event occurred in 406 patients (13.4%) in the lixisenatide group and in 399 (13.2%) in the placebo group (hazard ratio, 1.02; 95% confidence interval [CI], 0.89 to 1.17), which showed the noninferiority of lixisenatide to placebo (PCONCLUSIONS: In patients with type 2 diabetes and a recent acute coronary syndrome, the addition of lixisenatide to usual care did not significantly alter the rate of major cardiovascular events or other serious adverse events. (Funded by Sanofi; ELIXA ClinicalTrials.gov number, NCT01147250.).
- Published
- 2015