Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome.

Carla Giordano, Jean-Claude Tardif, Brian Claggett, Lin Ping, Xiaodan Wei, Aldo P. Maggioni, Lars V. Køber, Francesca C. Lawson, Kenneth Dickstein, Jeffrey L. Probstfield, Hertzel C. Gerstein, Matthew C. Riddle, Marc A. Pfeffer, Rafael Diaz, John J.V. Mcmurray, Scott D. Solomon, Eldrin F. Lewis

Risultato della ricerca: Article

986 Citazioni (Scopus)

Abstract

BACKGROUNDCardiovascular 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.METHODSWe 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.RESULTSThe 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 (P<0.001) but did not show superiority (P=0.81). There were no significant between-group differences in the rate of hospitalization for heart failure (hazard ratio in the lixisenatide group, 0.96; 95% CI, 0.75 to 1.23) or the rate of death (hazard ratio, 0.94; 95% CI, 0.78 to 1.13). Lixisenatide was not associated with a higher rate of serious adverse events or severe hypoglycemia, pancreatitis, pancreatic neoplasms, or allergic reactions than was placebo.CONCLUSIONSIn 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.)
Lingua originaleEnglish
pagine (da-a)2247-2257
Numero di pagine11
RivistaNew England Journal of Medicine
Volume373
Stato di pubblicazionePublished - 2015

    Fingerprint

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cita questo

Giordano, C., Tardif, J-C., Claggett, B., Ping, L., Wei, X., Maggioni, A. P., Køber, L. V., Lawson, F. C., Dickstein, K., Probstfield, J. L., Gerstein, H. C., Riddle, M. C., Pfeffer, M. A., Diaz, R., Mcmurray, J. J. V., Solomon, S. D., & Lewis, E. F. (2015). Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome. New England Journal of Medicine, 373, 2247-2257.