Further Analysis From ATHENA Study Showed That Multaq(R) (dronedarone) Reduced the Risk of Stroke in Patients With Atrial Fi...(der(with or without cardiovascular risk ...),Health

Date:9/3/2008

der (with or without cardiovascular risk factor) or above 70 years of age with at least one additional cardiovascular risk factor (hypertension, diabetes, previous cerebrovascular event, left atrium size greater than 50 mm or left ventricular ejection fraction lower than 40%). Patients were randomized to receive Multaq(R) 400 mg BID or placebo, with a maximum follow-up of 30 months.

The ATHENA study objectives were to show a potential benefit of Multaq(R) on the primary composite endpoint of all-cause mortality combined with cardiovascular hospitalization as compared to placebo. The pre-specified secondary endpoints were death from any cause, cardiovascular death and hospitalization for cardiovascular reasons. The pre-specified safety endpoint was the incidence of treatment emergent adverse events (between first study drug intake and last study drug intake plus 10 days) including: all adverse events, serious adverse events, adverse events leading to study drug discontinuation.

The ATHENA stroke post-hoc analysis on non-pre-specified secondary endpoint was conducted in order to confirm the consistent benefit of Multaq in atrial fibrillation or atrial flutter patients in reducing major cardiovascular complications like stroke, which is a leading cause of cardiovascular hospitalization or death in this patient population.

About Multaq(R) (dronedarone)

Multaq(R) is an investigational treatment and the only anti-arrhythmic drug (AAD) to have shown a significant reduction in morbidity and mortality in atrial fibrillation /atrial flutter patients with a favourable safety profile as evidenced by a low incidence of pro-arrhythmia (including torsades de pointes) and extra-cardiac organ toxicity. Multaq(R), discovered and developed by sanofi-aventis, has been studied in a clinical development program including more than 7,000 patients. Multaq(R) is one of the major therapeutic innovations for atrial fibrillation in the last twenty years.

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