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New England Journal of Medicine Publishes Results From the Landmark ATHENA Trial with Multaq(R) (dronedarone) in Atrial Fibrillation
Date:2/11/2009

/i>" commented Dr. Stefan H. Hohnloser J.W., Goethe University's Division of Clinical Electrophysiology, Frankfurt, Germany, principal investigator of the ATHENA study.

Reported significant adverse events in the Multaq(R) arm vs. placebo arm included diarrhea (9.7% vs. 6.2%), nausea (5.3% vs. 3.1%), bradycardia (3.5% vs. 1.2%), QT-interval prolongation (1.7% vs. 0.6%); skin disorders (10.3% vs. 7.6%) consisting mainly of rash, and an increase in blood creatinine (4.7% vs. 1.3%)*. There was no difference in permanent study drug discontinuation between Multaq(R) and placebo (30.2% vs. 30.8%).

Dr. Stuart J. Connolly, Director of the division of cardiology at McMaster University, Ontario, Canada and co-principal investigator of the ATHENA trial said "The clinical benefits observed with dronedarone in ATHENA occurred without a significantly higher rate of thyroid or pulmonary disorders compared with placebo reported within the study period."

About the ATHENA Study

The landmark ATHENA study is the only double-blind, antiarrhythmic study in patients with AF that assesses morbidity-mortality. The study was conducted at more than 550 sites in 37 countries and enrolled a total of 4,628 patients.

The patients studied in ATHENA were either 75 years of age or older (with or without cardiovascular risk factors) or below 75 years of age with at least one additional cardiovascular risk factor (hypertension, diabetes, previous ischemic cerebrovascular event, left atrium size greater than 50 mm or left ventricular ejection fraction lower than 40 percent). Patients with recently decompensated heart failure or in New York Heart Association (NYHA) class IV were excluded. Patients were randomized to receive dronedarone 400 mg BID or placebo, with a mean follow-up of 21 months.

The ATHENA study objectives were designed to show a potential benefit of dronedarone
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SOURCE sanofi-aventis
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