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ATHENA: Dronedarone reduced CV hospitalization, death in AF
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SAN FRANCISCO – During the ATHENA trial, dronedarone reduced the incidence of cardiovascular hospitalizations or death in patients with atrial fibrillation by 24%, according to results of the study.
Dronedarone (Multaq, Sanofi Aventis) also reduced time to first hospitalization by 25.5%.
Stefan H. Hohnloser, MD, director of the department of clinical electrophysiology, J.W. Goethe University in Frankfurt, Germany, said antiarrhythmic therapy continues to be a major therapeutic approach in AF, particularly in the elderly patient, but current antiarrhythmic drugs are limited by moderate efficacy and/or safety and tolerability issues. Dronedarone is a new investigational multi-channel blocker to prevent and treat AF or atrial flutter.
“Dronedarone ... proved to be effective and safe in reducing cardiovascular outcomes in patients with atrial fibrillation,” Hohnloser said in conclusion during his presentation at the Heart Rhythm Society’s 29th Annual Scientific Sessions held here.
The researchers randomized 4,628 patients with AF or atrial flutter to dronedarone 400 mg twice daily (n=2,301) or placebo (n=2,327). The primary outcome was time to first CV hospitalization or death from any cause “which has not been applied to any other atrial fibrillation trial before,” Hohnloser said. Secondary outcomes were all-cause mortality CV death and CV hospitalization.
There were 116 deaths in the dronedarone group and 139 in the placebo group. Researchers found that dronedarone reduced risk of CV hospitalization or death by 24% (P=0.001). There was a 30% reduction in the risk of CV death, including sudden death, on top of standard therapy including rate control drugs and antithrombotics, a pre-specified endpoint (P=0.03). Dronedarone delayed first CV hospitalizations by 25.5%, and showed a trend towards 16% less death from any cause than placebo.
Participants who stopped taking dronedarone reported mostly gastrointestinal side effects while in the placebo group participants reported recurrent AF.
“CV mortality, specifically arrhythmic death, was lower in the dronedarone group compared to placebo,” Hohnloser said. “The reduction of CV hospitalizations was mainly due to fewer admissions for atrial fibrillation and acute coronary syndromes.” — by Judith Rusk
Dr. Hohnloser is a paid consultant for Sanofi Aventis, BMS, ARYx, and Cardiome.
For more information:
- Hohnloser SH. Effects of dronedarone on cardiovascular outcomes in high-risk patients with atrial fibrillation or atrial flutter – results of the ATHENA trial. Session SP07. Presented at: Heart Rhythm Society 29th Annual Scientific Sessions; May 14-17, 2008; San Francisco.
This is a very important trial because it demonstrates for the first time the impact of a new antiarrhythmic drug in patients with AF. We desperately need better pharmacologic therapy for these patients. Dronedarone looks like it will provide a very useful choice of therapy.
–Douglas Zipes, MD
Cardiology Today Section Editor