Bydureon (exenatide extended release) in Phase IIIb/IV EXSCEL trial showed no increase in CV riskin adults with type-2 diabetes.- AstraZeneca

AstraZeneca announced top-line results from the Phase IIIb/IV EXSCEL (EXenatide Study of Cardiovascular Event Lowering) trial. The trial compared the effect of once-weekly Bydureon (exenatide extended-release) versus placebo, when added to usual type-2 diabetes care, on the risk of MACE, a composite endpoint of CV death, non-fatal myocardial infarction or non-fatal stroke, in adults with type-2 diabetes (T2D) at a wide range of CV risk.

The EXSCEL trial met its primary safety objective of non-inferiority for MACE. These results address the FDA requirement that medicines to treat T2D are not associated with an increase in CV risk. Fewer CV events were observed in the Bydureon arm of the trial, however, the efficacy objective of a superior reduction in MACE did not reach statistical significance. Data were consistent with the known safety profile of Bydureon.