AstraZeneca said top-line results for the Phase IIIb/IV EXSCEL (exenatide study of cardiovascular event lowering) clinical trial showed Bydureon (exenatide extended-release) when added to traditional type-2 diabetes care did not increase cardiovascular risk.
The study compared Bydureon added to traditional type-2 diabetes care versus a placebo to ensure that the medication does not increase the risk of major adverse cardiac events (MACE). Participants received a weekly injection of 2 mg of Bydureon or placebo.
“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," AstraZeneca Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development, Elisabeth Bjork said in a release. "Furthermore, the trial design and broad inclusion criteria of EXSCEL offer physicians relevant data applicable to clinical practice.”
While fewer cardiovascular events were observed in the patients treated with Bydureon, it was not a significant result in the study. More than 14,000 participants from 35 countries participated in the double-blind, placebo-controlled trial. It enrolled type-2 diabetics both with and without cardiovascular risk factors or prior events.
The results of the EXSCEL trial are still being evaluated. The data will be presented Sept. 14 at the European Association for the Study of Diabetes annual meeting in Portugal, the release said.