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Dronedarone (Multaq(R)) Reduced the Incidence and Duration of Hospitalization in Patients with Atrial Fibrillation
Date:11/11/2008

y double-blind, anti-arrhythmic, morbidity-mortality study in patients with AF. It was conducted in more than 550 sites in 37 countries and enrolled a total of 4,628 patients.

Previous results from the landmark ATHENA study have shown that dronedarone on top of standard therapy decreased the combined primary endpoint of cardiovascular hospitalization or death from any cause by a statistically significant 24 percent (p<0.001) as compared to placebo and reduced the risk of cardiovascular hospitalization by 25 percent (p<0.001). These results were achieved with a favorable safety profile.

The patients studied in ATHENA were either 75 years of age or older (with or without cardiovascular risk factor) either below 75 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 percent). Patients with decompensated heart failure (NYHA class IV) were excluded. Patients were randomized to receive dronedarone 400 mg BID or placebo, with a maximum follow-up of 30 months.

The ATHENA study objectives were to show a potential benefit of dronedarone 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 hospitalisation 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.

About dronedarone (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 AF/AFL patients with a favourable
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SOURCE sanofi-aventis
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