ELIXA trial demonstrates cardiovascular safety of type 2 drug lixisenatide

The blood glucose-lowering drug lixisenatide did not affect cardiovascular (CV) events in patients with type 2 diabetes and acute coronary syndromen, a new study finds.
The findings of the Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA) trial were presented at the European Society of Cardiology (ESC) Congress 2015.
Lixisenatide is a GLP-1 analogue manufactured by Sanofi and Aventis – it is marketed as Lyxumia. In the ELIXA trial, 6,608 patients with type 2 diabetes and a history of myocardial infarction (heart attack) or hospitalisation for unstable angina within the past 180 days were involved.
The patients were randomised either to daily lixisenatide injections or placebo for a minimum of 10 months. The primary outcome of the trial was to assess rates of CV death, heart attacks, stroke and hospitalisation for angina.
In the lixisenatide group, the primary outcome occurred in 13.4 per cent of patients. This figure was 13.2 per cent for the control group.
Dr. Eldrin F. Lewis, MD, MPH and a member of the ELIXA trial’s executive committee said that while the CV safety of lixisenatide was not superior to placebo, “the neutral effects on cardiovascular events are all within the limits of the EMA’s and FDA’s guidelines. In addition, lixisenatide provided a modest benefit in terms of weight gain.”
Lixisenatide was also safe in patients that had a history of heart failure, while patients hospitalised for heart failure had a nine-fold greater risk of all-cause death than those not hospitalised for heart failure. “This excess mortality suggests that these are important events to capture among patients with diabetes,” added Lewis.
This study is the first to report on the CV safety outcomes of a GLP-1 receptor agonist. Lewis further explained that the findings of this trial led to the European Medicines Agency (EMA) and United States Food and Drug Administration (FDA) establishing guidelines for trials testing CV safety of glucose-lowering drugs.
“Prior studies have established that patients with type 2 diabetes are at higher risk for incident cardiovascular disease than people who do not have type 2 diabetes, and some glucose-lowering drugs have been associated with increased risk of cardiovascular disease,” said Lewis.