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RESEARCH PRODUCT
Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome
Yan Carlos Duarte VeraLars KoberThomas R. PieberCafer ZorkunPonnusamy SaravananCristian PodoleanuAndrzej LubinskiAldo P. MaggioniFrancisco MarínYusuf BozkuşMartin GibsonBertrand CariouAnna Vittoria CiardulloNeslihan Bascil TutuncuVladimir V RafalskyVladimir ZadionchenkoJohn McmurrayParamesh SFernando T LanasVeronique KerlanJose SgarbiHertzel C. GersteinFernando ManzurSonia GaztambideAlan Jaapsubject
MaleMyocardial InfarctionKaplan-Meier Estimate2700 General MedicineType 2 diabetesAnginachemistry.chemical_compoundTreatment FailureMyocardial infarctionResearch Support Non-U.S. Gov'tHemoglobin AGeneral MedicineAnginaMiddle AgedMulticenter StudyCardiovascular DiseasesRandomized Controlled TrialCardiologyFemalelixisenatideType 2medicine.medical_specialtyAcute coronary syndromeGlycosylated610 Medicine & healthUnstableGlucagon-Like Peptide-1 Receptor11171 Cardiocentro TicinoLixisenatideAcute Coronary Syndrome; Aged; Angina Unstable; Cardiovascular Diseases; Diabetes Mellitus Type 2; Female; Glucagon-Like Peptide-1 Receptor; Hemoglobin A Glycosylated; Humans; Hypoglycemic Agents; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Peptides; Proportional Hazards Models; Treatment FailureInternal medicineJournal ArticleDiabetes MellitusmedicineHumansHypoglycemic AgentsAngina UnstableAcute Coronary SyndromeAgedProportional Hazards ModelsHemoglobin A GlycosylatedUnstable anginabusiness.industrySemaglutideta3121medicine.diseaseDiabetes Mellitus Type 2chemistryMyocardial infarction complicationsPeptidesbusinessdescription
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 (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.CONCLUSIONS: 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.).
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2015-12-03 | New England Journal of Medicine |