PARIS, May 12, 2010 /PRNewswire-FirstCall/ --
- New Outcomes Trial to Expand Evidence for Dronedarone in a Different AF Population
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today the initiation of a multinational, randomized double-blind Phase IIIb trial, PALLAS, to assess the potential clinical benefit of Multaq(R) (dronedarone) in over 10, 000 patients with permanent atrial fibrillation (AF) to reduce major adverse cardiovascular events. The announcement was made during Heart Rhythm 2010, the Heart Rhythm Society's 31st Annual Scientific Sessions.
In the U.S., Multaq(R) is indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age >70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter Ã¢â€°Â¥50 mm or left ventricular ejection fraction [LVEF] <40%), who are in sinus rhythm or who will be cardioverted.[i] 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.
Permanent AF afflicts 50% of patients suffering from AF and these
patients are at high risk of major adverse cardiovascular events. The trial
rationale was based on post-hoc findings from the landmark ATHENA trial, in
which a trend towards reduction of CV hospitalization and death was seen in
patients classified as "permanent" (i.e. with AF/AFL at each ECG r
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