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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

BRIDGEWATER, N.J., May 15 /PRNewswire-FirstCall/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that findings from the landmark ATHENA study showed Multaq(R) (dronedarone), a potential therapy for the treatment of patients with atrial fibrillation or atrial flutter, decreased the risk of cardiovascular hospitalizations or death from any cause by a statistically significant 24% (p=0.00000002), meeting the study primary endpoint. The ATHENA results will be presented at the late breaking clinical trial session of Heart Rhythm 2008, the Heart Rhythm Society's 29th Annual Scientific Sessions in San Francisco, USA.

For the first time in twenty years of clinical drug trials in atrial fibrillation, an investigational medicine, Multaq(R), showed a significant decrease in the risk of cardiovascular death by 30% (p=0.03) on top of standard therapy, including rate control and antithrombotic drugs, in patients with atrial fibrillation or atrial flutter. Multaq(R) also significantly decreased the risk for arrhythmic death by 45% (p=0.01), and there were numerically less deaths (16%) from any cause in the dronedarone group compared to placebo (p=0.17). First cardiovascular hospitalization was reduced by 25% (p=0.000000009) in the dronedarone group.

"The ATHENA results have the potential to change the face of atrial fibrillation management. For atrial fibrillation patients, who together with their physicians struggle on a daily basis to manage the dramatic consequences of this complex disease, Multaq(R) carries hope for patients," said Marc Cluzel, sanofi-aventis Senior Vice President, R&D. "This milestone is indicative of sanofi-aventis' commitment to bringing innovative therapies to market, and of our ongoing commitment to provide patients, physicians and public health stakeholders with breakthrough medicines in those therapeutic areas where there are major healthcare needs and limited solutions."

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