(HealthDay)—The addition of lixisenatide to usual care does not impact the rate of major cardiovascular events or other serious adverse events among patients with type 2 diabetes and a recent acute coronary syndrome, according to a study published in the Dec. 3 issue of the New England Journal of Medicine.
Marc A. Pfeffer, M.D., Ph.D., from Brigham and Women's Hospital in Boston, and colleagues randomized patients with type 2 diabetes who had had myocardial infarction or who had been hospitalized for unstable angina within the prior 180 days to lixisenatide or placebo. A total of 6,068 patients were randomized and followed for a median of 25 months.
The researchers found that a primary end point event (cardiovascular death, myocardial infarction, stroke, or hospitalization for unstable angina) occurred in 13.4 and 13.2 percent of the lixisenatide and placebo groups, respectively (hazard ratio, 1.02; 95 percent confidence interval, 0.89 to 1.17), demonstrating noninferiority (P < 0.001) but not superiority (P = 0.81). No significant between-group differences were seen in the rate of hospitalization for heart failure (hazard ratio, 0.96; 95 percent confidence interval, 0.75 to 1.23) or death (hazard ratio, 0.94; 95 percent confidence interval, 0.78 to 1.13).
"The neutral cardiovascular profile associated with lixisenatide will inform physicians' and patients' decisions regarding the use of this agent as an adjunctive therapy to control the glycated hemoglobin level safely," the authors write.
The study was funded by Sanofi, the manufacturer of lixisenatide.
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Journal information: New England Journal of Medicine
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