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FDA Approves Multaq(R) for Patients with Atrial Fibrillation or Atrial Flutter
Date:7/2/2009

nnovations in patients with atrial fibrillation in the last twenty years.

The efficacy and safety of Multaq(R) 400 mg twice daily was evaluated in five controlled studies, ATHENA, ANDROMEDA, EURIDIS, ADONIS, and DAFNE, involving nearly 6,300 patients including more than 3200 patients who received Multaq(R).

The ATHENA trial, which involved 4,628 patients with AF or AFL and more than 2,300 patients receiving Multaq(R) on top of standard therapy, demonstrated a 24% reduction in time to first CV hospitalization or all-cause mortality (P<0.001) compared with placebo meeting the primary endpoint.

The ANDROMEDA study, was terminated prematurely after enrolment of 627 of 1000 planned patients with congestive heart failure, in relation to excess mortality due to worsening heart failure in the dronedarone group [n=25 versus 12 (placebo), p=0.027].

The patient population enrolled in the ANDROMEDA and ATHENA studies was significantly different. The patients enrolled in ANDROMEDA had relatively severe heart failure and had been hospitalized, or referred to a specialty heart failure clinic for worsening symptoms. Patients were predominantly NYHA II and III (New York Heart Association classification) and only 25% had a history of AF/AFL at randomization. In contrast, in ATHENA, all patients had a history of AF/AFL, and 71% of patients had no heart failure, 25% were NYHA class I or II, and only 4% were class III.

The ANDROMEDA and ATHENA trials were published in the New England Journal of Medicine (NEJM) respectively in 2008 and 2009.

Important Safety Information

Multaq(R) is contraindicated in patients with NYHA Class IV heart failure or NYHA Class II-III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic. In a placebo-controlled study in patients with severe heart failure requiring recent
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SOURCE sanofi-aventis
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