2005 AHA Scientific Sessions: EURIDES/ADONIS

Dronedarone, a class III multichannel blocker developed for maintenance of sinus rhythm and ventricular rate control, reduces the risk of all-cause hospitalizations and death in patients with atrial fibrillation/flutter (AF/AFl), according to a post-hoc analysis of 2 randomized, placebo-controlled clinical trials.

The analysis pooled data from EURIDIS (European Trial in Atrial Fibrillation or Flutter Patients Receiving Dronedarone For the Maintenance of Sinus Rhythm), a trial conducted in 612 patients, and ADONIS (American-Australian Trial with Dronedarone In Atrial Fibrillation or Flutter Patients For the Maintenance of Sinus Rhythm), which involved 625 patients. The 2 trials were multicenter, double-blind, placebo-controlled studies with a common protocol designed to assess the efficacy of dronedarone 400 mg twice daily for the maintenance of normal sinus rhythm in patients with AF/AFl.

To be eligible, patients had to be in sinus rhythm for at least 1 hour at the time of randomization and have experienced at least 1 episode of AF/AFl during the previous 3 months.

The main results from EURIDIS and ADONIS were presented at the 2004 European Society of Cardiology Congress. The primary end point-an episode of AF/AFl lasting 10 or more minutes-was achieved by 22% fewer dronedarone recipients (P=.0318) in EURIDIS and 28% fewer dronedarone recipients in ADONIS (P=.0017), compared with placebo.