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The New England Journal of Medicine Publishes EURIDIS/ADONIS Study Results Showing Dronedarone Maintained Sinus Rhythm in Patients With Atrial Fibrillation or Flutter With no Observed Pro-Arrhythmia
Date:9/5/2007

PARIS, Sept. 5 /PRNewswire-FirstCall/ -- Sanofi-aventis announced the publication of two international trials -- EURIDIS and ADONIS -- which demonstrated that dronedarone (MULTAQ(TM)), a new anti-arrhythmic agent in late stage development, is significantly more effective than placebo in maintaining sinus rhythm while not promoting pro-arrhythmias or organ toxicity (pulmonary, thyroid, liver) in patients with atrial fibrillation (AF) and atrial flutter (AFL).

AF, the most common type of irregular heart beat worldwide, is a condition in which the upper chamber of the heart beats in an uncoordinated and disorganized fashion, resulting in a very irregular and fast heart rhythm, which can potentially lead to serious cardiovascular complications. The disease affects close to one percent of the population which equates to around six million people in Europe and the US. This estimate is forecasted to increase to more than 5.6 million in the U.S. by 2050, largely due to the ageing population. AF is increasingly recognized as a progressive cardiovascular disease associated with increased morbidity and mortality.

EURIDIS (EURopean trial In atrial fibrillation patients receiving Dronedarone for the maintenance of Sinus rhythm) and ADONIS (American- Australian-African trial with Dronedarone In atrial fibrillation patients for the maintenance of Sinus rhythm), have the same methodologies and evaluated the ability of dronedarone to maintain sinus rhythm in patients with AF and AFL.

In the EURIDIS and ADONIS trials, the median times to arrhythmia recurrence were significantly longer for dronedarone than placebo for the primary endpoint. For the EURIDIS trial, 96 days versus 41 days (p=0,014) and for the ADONIS trial, 158 days versus 59 days (p=0,002).

In the two trials, at 12 months, significantly fewer patients experienced an AF/AFL recurrence in the dronedarone group compared to the placebo groups. For the EURIDIS trial, 67.1 percent versus 77.5 per
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