Bydureon Passes CV Safety Test

— But doesn't prove superior, according to top-line results

by Kristen Monaco, Staff Writer, �鶹��ý May 23, 2017

Last Updated May 24, 2017

This article is a collaboration between �鶹��ý and:

The once-weekly type 2 diabetes therapy exenatide (Bydureon) hit non-inferiority for cardiovascular events compared with placebo, but missed on measures of superiority, according to top-line results from released by drugmaker AstraZeneca.

The drug didn't raise the risk of a composite of cardiovascular death, non-fatal MI, or non-fatal stroke (MACE), and while there were fewer cardiovascular events in the Bydureon group, the efficacy endpoint of superior reduction in MACE didn't reach statistical significance, the company said.

So far, the FDA has only approved empagliflozin for label language about the reduction of cardiovascular risk in patients with type 2 diabetes.

AstraZeneca said the phase IIIb/IV EXSCEL trial is the largest and most inclusive patient population of any cardiovascular outcomes trial of GLP-1 agonists conducted to date, enrolling more than 14,000 patients with type 2 diabetes from 35 countries. The FDA has been requiring makers of all newly approved type 2 diabetes drugs to conduct post-marketing cardiovascular safety trials, after studies indicated that rosiglitazone (Avandia) increased risk of adverse cardiovascular events. To date, none has found a safety problem and three have demonstrated protective effects.

Full findings of the EXSCEL trial will be presented at the European Association for the Study of Diabetes (EASD) annual meeting in Lisbon this September.

Kristen Monaco is a senior staff writer, focusing on endocrinology, psychiatry, and nephrology news. Based out of the New York City office, she’s worked at the company since 2015.