May 21, 2008 - Dronedarone significantly reduces the incidence of cardiovascular hospitalization or death in patients with atrial fibrillation (AF), according to results of the ATHENA Trial presented at Heart Rhythm 2008.
Dronedarone is a new antiarrhythmic compound being developed for the treatment of atrial fibrillation and atrial flutter. The ATHENA Trial is a placebo-controlled, double-blind, morbidity and mortality study designed to assess the efficacy of dronedarone for the prevention of cardiovascular hospitalization or death from any cause in patients with AF or atrial flutter.
“ATHENA is the first large trial of an antiarrhythmic agent that measures if an antiarrhythmic drug can reduce the composite outcome of the time to first cardiovascular hospitalization or death from any cause in an AF population,” stated the trial’s lead author, Stefan H. Hohnloser, MD, FHRS at J.W. Goethe University in Frankfurt, Germany. “The positive effects of dronedarone on the AF population are significant and extremely important to the field of cardiology.”
The trial randomized 4,628 patients with AF or atrial flutter, or with a history of the disorder to receive dronedarone or placebo with a minimum follow-up of one year. The primary study outcome was time to first cardiovascular hospitalization or death from any cause and secondary outcomes were total death, cardiovascular death and cardiovascular hospitalization.
The study findings included:
* 24.2 percent reduction in the risk of cardiovascular hospitalization or death from any cause during the study period, the study primary endpoint (p=0.001)
* 30 percent reduction in the risk of cardiovascular death (including sudden death) on top of standard therapy, including rate control drugs and antithrombotics, a pre-specified secondary endpoint (p=0.03)
* 25.5 percent reduction of first cardiovascular hospitalizations (p=0.001)
* A trend towards 16 percent less death from any cause (p=0.18)
* Lower mortality overall in the dronedarone arm compared to the placebo group at all times of the study
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