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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

- Multaq(R) (dronedarone) significantly reduced the risk of cardiovascular hospitalization or death by 24 percent in patients with atrial fibrillation -

PARIS, Feb. 11 /PRNewswire-FirstCall/ -- Sanofi-aventis (Paris Bourse: EURONEXT: SAN; and New York: NYSE: SNY) announced today that the ATHENA trial was published in the New England Journal of Medicine. The trial showed that Multaq(R) (dronedarone), in addition to standard therapy, significantly reduced the risk of first cardiovascular hospitalization or death by 24 percent (31.9% vs. 39.4%, p<0.001) in patients with atrial fibrillation (AF)/atrial flutter (AFL) or a recent history of these conditions.

Atrial fibrillation is the leading cause of hospitalization for arrhythmia in the US(1) and represents one-third of hospitalizations for arrhythmia in Europe(2). Hospitalization due to AF has increased dramatically (two-to-three fold) in recent years in the US(1). Atrial fibrillation is a complex disease that increases the risk of stroke up to five-fold(3), worsens the prognosis of patients with cardiovascular risk factors(4) and that doubles the risk of mortality(5).

The authors' findings, as reported in the New England Journal of Medicine, showed a significant decrease in the risk of cardiovascular death by 29 per cent (p=0.03) in patients with AF. Multaq significantly decreased the risk of arrhythmic death by 45 per cent (p=0.01) and there were numerically fewer deaths (16 per cent) from any cause in the dronedarone group compared to placebo (p=0.18). First cardiovascular hospitalization was reduced by 26 per cent (p<0.001) in the dronedarone group.

"The ATHENA trial is the first trial to show a reduction in the incidence of cardiovascular hospitalization or death in patients taking an anti-arrhythmic drug for atrial fibrillation<
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SOURCE sanofi-aventis
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