EXSCEL trial with Bydureon (exenatide extended-release) in patients with type-2 diabetes shows CV safety.- AstraZeneca.

AstraZeneca announced full results from the EXSCEL (EXenatide Study of Cardiovascular Event Lowering) trial that showed cardiovascular safety with Bydureon (exenatide extended-release) in patients with type-2 diabetes (T2D) at a wide range of CV risk. Exenatide once-weekly did not increase the incidence of major adverse cardiovascular events (MACE), a composite endpoint of CV death, non-fatal heart attack (myocardial infarction) or non-fatal stroke, compared to placebo. There were also fewer CV events observed in the exenatide arm of the trial (839 [11.4%] versus 905 [12.2%]), although the primary efficacy objective of a superior reduction in MACE narrowly missed statistical significance. The direction of the cardiovascular outcomes results in EXSCEL was consistent with those seen in recently completed outcomes trials within the GLP-1 receptor agonist class.

Additionally, in a prespecified secondary analysis, patients on exenatide had a 14% lower incidence of death from all causes. The full results of EXSCEL, including important secondary endpoints, sensitivity analyses and regional data, were presented at the 53rd annual meeting of EASD and simultaneously published online in the New England Journal of Medicine.

Comment: The EXSCEL trial enrolled the largest and most inclusive patient population of any CV outcomes trial of the glucagon-like peptide-1 (GLP-1) receptor agonist class conducted to date, having included more than 14,500 patients at 687 trial sites across 35 countries, incorporating usual care and wide-ranging eligibility criteria. AstraZeneca is working with regulatory authorities to incorporate these data into the Bydureon label.