top of page

Effects of Once-Weekly Exenatide on Cardiovascular Outcomes

Information sourced from NEJM Journal Watch:

Effects of Once-Weekly Exenatide on Cardiovascular Outcomes

Compared with placebo, this diabetes drug demonstrated neither harm nor significant benefit.

To satisfy regulatory requirements about showing cardiovascular (CV) safety of new diabetes medications, industry-sponsored researchers have conducted this randomized trial of once-weekly injected exenatide (Bydureon), a glucagon-like peptide-1 (GLP-1)-receptor agonist. Nearly 15,000 patients (mean age, 62) with longstanding type 2 diabetes received exenatide or placebo. During the trial, patients were permitted to use other diabetes drugs (oral agents and insulin). At baseline, about 70% of patients had experienced previous adverse CV events, and glycosylated hemoglobin (HbA1c) level averaged 8%.

During average follow-up of about 3 years, mean HbA1c levels changed little in the placebo group and dropped by roughly 0.5% in the exenatide group. The incidence of the primary CV outcome (CV-related death, myocardial infarction, or stroke) was 11.4% in the exenatide group and 12.2% in the placebo group. This difference met statistical criteria for exenatide’s noninferiority (for safety) but not superiority (for efficacy).


In this study, exenatide did not demonstrate CV harm, but it fell short of showing a statistically significant CV benefit. In contrast, another FDA-approved GLP-1 analogue (liraglutide) was associated with a significant 2 percentage-point reduction in adverse CV events during 4 years (NEJM JW Gen Med Jul 15 2016 and N Engl J Med 2016; 375:311). This apparent inconsistency might reflect intrinsically different CV effects of the two drugs or just differences in various aspects of the two trials.

Allan S. Brett, MD reviewing Holman RR et al. N Engl J Med 2017 Sep 28.


Holman RR et al. Effects of once-weekly exenatide on cardiovascular outcomes in type 2 diabetes. N Engl J Med 2017 Sep 28; 377:1228. [PubMed® abstract]

NEJM Journal Watch is produced by NEJM Group, a division of the Massachusetts Medical Society. Copyright ©2017 Massachusetts Medical Society. All rights reserved.

The above message comes from NEJM Journal Watch, who is solely responsible for its content.

Featured Monthly Article
Please reload

Recent News

Curt Wood, R.Ph., FASCP

Board Certified Geriatric Pharmacist

Elder Care Pharmacy Consultants take pride in being truly independent. Elder Care Pharmacy Consultants, LLC. has a comprehensive approach to antipsychotic use in order to help ensure nursing homes reach their goals, enhance star quality measures, and maintain federal and state compliance. Our success depends on your satisfaction with the services we provide..

bottom of page