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Further Analysis From ATHENA Study Showed That Multaq(R) (dronedarone) Reduced the Risk of Stroke in Patients With Atrial Fibrillation
Date:9/3/2008

This analysis showed that Multaq(R) (dronedarone) decreased the risk of stroke by 34% in patient with atrial fibrillation or atrial flutter already

adequately treated by antithrombotic therapy

BRIDGEWATER, N.J., Sept. 3 /PRNewswire-FirstCall/ -- The results of a post-hoc analysis of the data from the ATHENA study were presented today at the clinical trial update session of the European Society of Cardiology congress 2008, in Munich, Germany. Previous results from the landmark ATHENA study have shown that the investigational medicine Multaq(R) (dronedarone) on top of standard therapy decreased the combined primary endpoint of the risk of cardiovascular hospitalizations or death from any cause by a statistically significant 24% (p=0.00000002) as compared to placebo.

The ATHENA stroke post-hoc analysis on non-pre-specified secondary endpoints showed that Multaq(R) decreased the risk of stroke (ischemic or haemorrhagic) compared to placebo by 34% (46 vs 70 stroke events respectively; p=0.027) in atrial fibrillation / atrial flutter patients adequately treated by standard therapy including antithrombotics.

The significant reduction in stroke risk with Multaq(R) was incremental to background anti-thrombotic therapy like oral anticoagulants and / or anti-platelet agents. Similar to the ATHENA primary endpoint of CV hospitalizations or death, this effect appeared early and was maintained during the study follow-up (12 to 30 months).

"ATHENA is a landmark trial that will lead to a paradigm shift in the management of atrial fibrillation as it is the first time that an anti-arrhythmic drug has shown a significant impact on cardiovascular outcomes. As stroke is one of the leading complications of atrial fibrillation, and a major cause of death and long-term disability, these new results demonstrate the unique profile of Multaq(R) beyond its pure rhythm and rate-controlling effects," said Professor Stuart Connolly, Mc Master Uni
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SOURCE sanofi-aventis
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