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Landmark ATHENA Study Findings With Multaq(R) (dronedarone) Shows 24% Reduction In Cardiovascular Hospitalization or Death in Patients With Atrial Fibrillation
Date:5/15/2008

imilar rate of study drug discontinuation between the 2 study groups.

"ATHENA is truly a landmark trial, that marks a potential paradigm change for the management of atrial fibrillation," said Dr. Christopher Cannon, a Senior Investigator in the TIMI Study Group at Brigham and Women's Hospital, who was not involved in the study. "Atrial fibrillation is a very common disease, and our prior treatment options have been focused only on symptom relief and a hope to not do harm, which has been the problem with prior antiarrhythmic drugs. Now, with the ATHENA study demonstrating a highly significant reduction in death or hospitalization, as well as a 45% reduction in arrhythmic death or 30% cardiovascular death, dronedarone may become an appropriate treatment option for atrial fibrillation."

ATHENA, the largest double blind randomized study in patients with atrial fibrillation, was conducted in more than 550 sites in 37 countries and enrolled a total of 4,628 patients. The ATHENA landmark trial is the first morbidity-mortality study as part of the Multaq(R) phase III clinical development program, which also included five other multinational clinical studies, an initial study, ANDROMEDA, conducted in patients with severe congestive heart failure and a recent decompensation, and a total of 4 international studies in atrial fibrillation: EURIDIS/ADONIS, ERATO, and the ongoing DIONYSOS trial.

Based upon this new clinical data, sanofi-aventis plans to submit a registration dossier to the European Medicines Agency (EMEA), and a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) during the 3rd quarter of 2008.

About Atrial Fibrillation / Flutter

Atrial fibrillation is a major cause of hospitalization and mortality and affects about 2.5 million people in the USA and 4.5 million people in the European Union. The Atrial Fibrillation Foundation expects the number of patients with AF to double in the next 20 years. Without appr
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