Results from a large-scale Phase 3 clinical trial, EXSCEL, assessing the cardiovascular risk of AstraZeneca’s (AZN +0.1%) BYDUREON (exenatide extended-release) in type 2 diabetics showed similarity to placebo. The data were presented at European Association for the Study of Diabetes (EASD) Annual Meeting in Lisbon and simultaneously published online in the New England Journal of Medicine.
Patients who received once-weekly BYDUREON did not experience more major adverse cardiac events (MACE) than those receiving placebo (non-inferiority).
The incidence of CV events was actually lower in the treatment arm (11.4% vs. 12.5%) but the difference was not statistically valid (p=0.061). Patients in the exenatide arm had 14% less risk of death from all causes (hazard ratio = 0.86).
BYDUREON is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The company is working with regulatory authorities to include the data in the drug’s label.