Late-Breaking Clinical Trial Results Announced at Heart Rhythm 2008: ATHENA Trial
A new antiarrhythmic compound proves to reduce the incidence of cardiovascular hospitalizations in patients with AF

FOR IMMEDIATE RELEASE
Contact: Ann-Marie White
Heart Rhythm Society
(202) 464-3476
awhite@hrsonline.org

Lucy McDonald: (202) 306-3456
Heart Rhythm 2008 Press Room: (415) 978-3520 (number effective May 14-17, 2008)

SAN FRANCISCO, May 15, 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 today at Heart Rhythm 2008, the Heart Rhythm Society’s 29th Annual Scientific Sessions. 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 % reduction in the risk of cardiovascular hospitalization or death from any cause during the study period, the study primary endpoint (p=0.001)
• 30% 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% reduction of first cardiovascular hospitalizations (p=0.001)
• A trend towards 16% 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

More on Heart Rhythm 2008's Late-Breaking Clinical Trials.

About Heart Rhythm2008
Heart Rhythm 2008 takes place May 14-17 at the Moscone Convention Center in San Francisco. The meeting is the most comprehensive educational event on heart rhythm disorders, offering 250 educational opportunities in multiple formats. The world’s most renowned scientists and physicians will present a wide range of heart rhythm topics including advances in statins, cardiac resynchronization therapy, catheter ablation, cardiac pacing and heart failure and the latest technology, including state-of-the-art pacemakers and defibrillators.