Results of the ELIXA (Evaluation of Lixisenatide in Type 2 diabetes and Acute Coronary Syndrome) trial have been published in the New England Journal of Medicine, demonstrating that lixisenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist, does not increase the risk of cardiovascular (CV) adverse events compared with placebo. First presented at the American Diabetes Association’s Annual Scientific Sessions in June, these are the first data for a GLP-1 analogue to be published in response to the US Food and Drug Administration’s 2008 mandate that all new drugs for type 2 diabetes should be evaluated for CV safety.
In the study, 6068 people with type 2 diabetes who had had a myocardial infarction (MI) or who had been hospitalised for unstable angina within the previous 180 days were randomised to receive lixisenatide or placebo in addition to standard care. The primary endpoint was a composite of death from CV causes, non-fatal MI, non-fatal stroke or hospitalisation for unstable angina.
Over a median follow-up of 25 months, a primary endpoint event occurred in 13.4% of participants in the lixisenatide group and 13.2% in the placebo group (hazard ratio, 1.02; 95% confidence interval, 0.89–1.17). In terms of these outcomes, lixisenatide was found to be non-inferior, but not superior, to placebo. Similarly, there were no differences between the groups in terms of hospitalisation for heart failure or mortality, and there was no difference in the rate of serious adverse events, severe hypoglycemia, pancreatitis, pancreatic neoplasm or allergic reaction. Small but significant improvements in HbA1c and body weight were also observed in the lixisenatide group, despite optimal background treatment occurring in both groups.
The study can be read in full here.
