Abstract 17573: Exenatide for Neuroprotection After Out-of-Hospital Cardiac Arrest, a Double-blind Randomized Controlled Trial
Introduction: In-hospital mortality after resuscitation from out-of-hospital cardiac arrest (OHCA) has decreased over the last decade but remains at 30 to 50%. Neurological injury secondary to ischemia and reperfusion is the primary cause of death in these patients. Glucagon-like peptide-1 (GLP-1) analogues are approved for treatment of type 2 diabetes, and pre-clinical and clinical trials suggest that GLP-1 analogues have organ protective effects in patients experiencing ischemia and reperfusion.
Hypothesis: The present double-blinded multicentre trial investigates the neuroprotective effects of the GLP-1 analogue exenatide administered to comatose patients resuscitated from OHCA.
Methods: A total of 120 comatose OHCA patients were included in this trial. Patients were randomized 1:1 to receive a 6 hour and 15 minutes infusion of either 17.4 μg exenatide (Byetta®) or placebo in addition to standardized intensive care including targeted temperature management.
The co-primary endpoint was
a) Feasibility, defined as initiation of the trial intervention in more than 90% of patients within 240 minutes from return of spontaneous circulation (ROSC), and
b) Efficacy, defined as the geometrical area under the biomarker neuron-specific enolase (NSE) curve from 24 to 72 hours after admission in the two trial arms.
The main secondary endpoints included all cause mortality as well as a composite outcome of death and poor neurological function defined as a cerebral performance category (CPC) of 3 to 5 and modified Rankin Scale (mRS) of 4 to 6 at 30 and 180 days after OHCA.
Results: Inclusion of 120 unconscious OHCA patients has been completed. Final follow-up has been concluded the 1st of June 2016 with a mean time to follow-up of 259 days and no patients being lost. The 180-day mortality in our cohort is 33%.
The randomization allocation will be un-blinded the 17th of June 2016, and we wish to present the results on all pre-defined endpoints for the first time at the American Heart Association Scientific Sessions 2016.
Author Disclosures: S. Wiberg: None. C. Hassager: None. H. Schmidt: None. J.H. Thomsen: None. M. Frydland: None. S. Boesgaard: None. D.E. Høfsten: None. T. Engstrøm: None. L. Køber: None. J.E. Møller: None. J. Kjaergaard: None.
- © 2016 by American Heart Association, Inc.