On behalf of the Steering Committee of the EURopean trial In atrial fibrillation or flutter patients receiving Dronedarone for the maIntenance of Sinus rhythm
Results of the EURIDIS trial announced at the European Society of Cardiology 2004 Congress
Results of the EURIDIS trial (EURopean trial In atrial fibrillation or flutter patients receiving Dronedarone for the maIntenance of Sinus rhythm), announced today at the European Society of Cardiology (ESC 2004) annual meeting, showed that the new antiarrhythmic agent, dronedarone, is highly effective in the prevention of both symptomatic and asymptomatic recurrences of atrial fibrillation (AF)/atrial flutter (AFL), and has a safety profile that is comparable to that observed with placebo in this patient population.
The EURIDIS trial and its sister trial ADONIS (American-Australian-African trial with DronedarONe In atrial fibrillation or flutter patients for the maintenance of Sinus rhythm) constitute the largest programme ever conducted in AF/AFL in terms of rhythm control strategy. The EURIDIS trial was conducted in 14 countries and 77 centres throughout Europe and involved a total of 612 patients aged 21 years or older. All patients enrolled in the trial had been in sinus rhythm for at least one hour at the time of randomisation and had had at least one ECG-documented atrial fibrillation in the previous three months. Using 2:1 randomisation to ensure optimal safety evaluation, patients received either dronedarone 400mg, twice daily (n = 411) or placebo (n = 201) and were treated for 12 months. The primary endpoint of the study was the time from randomisation to the first documented AF/AFL recurrence, defined as an episode lasting for ten minutes or more as indicated by two consecutive 12-lead electrocardiograms (ECGs) or Trans-Telephonic Electrocardiographic Monitoring (TTEM) tracings recorded approximately 10 minutes apart and both showing atrial fibrillation or flutter.
"The EURIDIS study showed that dronedarone has superior anti-arrhythmic efficacy compared to placebo. Dronedarone proved effective for all recurrences of atrial fibrillation or flutter, including those that were symptomatic, and also greatly lowered heart rate during recurrences," said Stefan Hohnloser MD, PhD, Professor of Medicine, Department of Internal Medicine J.W. Goethe University, Frankfurt, Germany and member of the Steering Committee of the EURIDIS trial. "Dronedarone proved to be well tolerated in this patient population, with an overall incidence of adverse events comparable to placebo," he added.
The EURIDIS study findings showed that the median time from randomisation to a first adjudicated recurrence of AF/AFL in the dronedarone group was 2.3 times longer than in the placebo group. Dronedarone significantly lowered the risk of first recurrence of AF/AFL within the 12-month study period by 21.6% compared to placebo (logrank test p=0.0138).
In both groups, the majority of first AF/AFL recurrences were symptomatic. The log-rank test showed a statistically significant difference between the two treatment groups (p=0.0055) for the time to adjudicated first symptomatic AF/AFL recurrence.
Transient emergent adverse events were comparable in both groups (58.2% of patients in the placebo group and 59.4% in the dronedarone group, (p=ns)). There was no evidence of proarrhythmia and no episodes of the potentially fatal condition, torsade de pointes, in the dronedarone group during the 12 month study period.
"The promising findings of the EURIDIS study are totally consistent with those of the ADONIS trial, which was conducted in the same patient population in North and South America, South Africa and Australia," said Bramah N. Singh, MD, PhD, Professor of Medicine, Department of Medicine, Cardiology Division, UCLA Medical School and Chairman of the ADONIS trial Steering Committee. "The primary endpoint of both trials is sensitive and also innovative. TTEM is a valid methodology for measuring treatment effect on recurrences of AF and the safety of dronedarone appears to be very good with no significant adverse events reported," he added.
European Society of Cardiology (ESC). August 29, 2004.