Results from the ATHENA trial, reported in the 12th February issue of the New England Journal of Medicine, suggest that the (as yet unlicensed) antiarrhythmic drug dronedarone can reduce the incidence of cardiovascular-related hospitalisation or death in patients with atrial fibrillation. The study was performed at more than 550 centres in 37 countries.
The trial, with a mean follow-up of 21 months, randomised 4628 patients with atrial fibrillation and at least one other cardiovascular risk factor to either dronedarone or placebo. Results found 24% fewer deaths or hospitalisations (the primary composite endpoint) in the treatment group than in the placebo – a hazard ratio for treatment of 0.76, p<0.001 (31.9% vs 39.4%).
The ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation have described dronedarone as a derivative of amiodarone (a well established and recommended treatment for atrial fibrillation) under development as an ion-channel blocking drug.
Speaking on behalf of the European Society of Cardiology, Professor Christophe Leclercq from the CHU in Rennes, France, said: "The ATHENA trial shows that dronedarone, a new antiarryhtmic drug similar to amiodarone but with different effects on individual ion channels, reduced the risk of death or hospitalisation for cardiovascular reasons by 36% when compared with placebo. This was in patients without severe heart failure (NYHA class IV) but with paroxysmal or persistent atrial fibrillation or flutter with additional risk factor for death.
"The study found no difference in overall mortality between the two groups but cardiovascular death was significantly reduced with dronedarone by 29%. There was no difference in thyroid-related effects between the two groups. The EURIDIS and ADONIS trials have already shown that dronedarone significantly reduced the recurrence of arrythmias in patients with paroxysmal or persistent atrial fibrillation.
"Dronedarone may thus play a role in the management of atrial arrhythmias in patients with paroxysmal or persistent atrial tachycardias without severe heart failure."