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EXSCEL: Exenatide meets primary safety objective for CV risk in type 2 diabetes
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Top-line results from the EXSEL trial show the GLP-1 receptor agonist exenatide extended release met the primary safety objective of non-inferiority for major adverse cardiac events in patients with type 2 diabetes when compared with placebo, Astra Zeneca announced in a press release.
The Exenatide Study of Cardiovascular Event Lowering trial compared the effect of once-weekly exenatide extended release (Bydureon) added to usual care with placebo on the risk for the composite endpoint of CV death, non-fatal myocardial infarction or non-fatal stroke, in adults with type-2 diabetes at a wide range of CV risk. The EXSCEL trial is the largest and most inclusive patient population of any CV outcomes trial of the GLP-1 receptor agonist class conducted to date, including more than 14,000 patients from 35 countries, according to the release.
Fewer CV events were observed in the exenatide arm of the trial; however, the efficacy objective of a superior reduction in major adverse cardiac events did not reach statistical significance, according to the release. Data were consistent with the known safety profile of exenatide.
“These top-line results from the EXSCEL trial provide robust evidence of the cardiovascular safety profile of Bydureon across a wide range of patients with type 2 diabetes,” Elisabeth Björk, vice president, head of cardiovascular and metabolic diseases, Global Medicines Development, AstraZeneca, said in a statement. “Furthermore, the trial design and broad inclusion criteria of EXSCEL offer physicians relevant data applicable to clinical practice.”
A full evaluation of the EXSCEL data is ongoing. The results will be presented at the European Association for the Study of Diabetes annual meeting in September 2017, in Lisbon, Portugal.