TY - JOUR
T1 - Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome
AU - Pfeffer, Marc A
AU - Claggett, Brian
AU - Diaz, Rafael
AU - Dickstein, Kenneth
AU - Gerstein, Hertzel C
AU - Køber, Lars V
AU - Lawson, Francesca C
AU - Ping, Lin
AU - Wei, Xiaodan
AU - Lewis, Eldrin F
AU - Maggioni, Aldo P
AU - McMurray, John J V
AU - Probstfield, Jeffrey L
AU - Riddle, Matthew C
AU - Solomon, Scott D
AU - Tardif, Jean-Claude
AU - ELIXA Investigators (Henrik Nielsen , members)
A2 - Nielsen, Henrik
A2 - Brønnum-Schou, Jens
A2 - Rungby, Jørgen
PY - 2015/12/3
Y1 - 2015/12/3
N2 - 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.).
AB - 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.).
KW - Acute Coronary Syndrome
KW - Aged
KW - Angina, Unstable
KW - Cardiovascular Diseases
KW - Diabetes Mellitus, Type 2
KW - Female
KW - Glucagon-Like Peptide-1 Receptor
KW - Hemoglobin A, Glycosylated
KW - Humans
KW - Hypoglycemic Agents
KW - Kaplan-Meier Estimate
KW - Male
KW - Middle Aged
KW - Myocardial Infarction
KW - Peptides
KW - Proportional Hazards Models
KW - Treatment Failure
KW - Journal Article
KW - Multicenter Study
KW - Randomized Controlled Trial
KW - Research Support, Non-U.S. Gov't
U2 - 10.1056/NEJMoa1509225
DO - 10.1056/NEJMoa1509225
M3 - Journal article
C2 - 26630143
SN - 0028-4793
VL - 373
SP - 2247
EP - 2257
JO - The New England journal of medicine
JF - The New England journal of medicine
IS - 23
ER -