Multaq Tablets Treat Atrial Fibrillation and Atrial Flutter


July 6, 2009

Sanofi-aventis offers Multaq (dronedarone) 400 mg tablets for use in patients with atrial fibrillation (AF) or atrial flutter (AFL).

Multaq is the first drug approved in the United States that has shown a clinical benefit to reduce cardiovascular hospitalization in patients with AF/AFL, the company said. Multaq is an antiarrhythmic indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent AF or AFL, with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted. Associated cardiovascular risk factors include age over 70 years, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter greater than or equal to 50 mm or left ventricular ejection fraction of less than 40 percent.

The FDA approved the pharmaceutical in July 2009.

Five international, multicenter, randomized clinical trials involving nearly 6,300 patients evaluated the efficacy and safety of Multaq in patients with AF/AFL. The company said Multaq 400 mg, in addition to standard therapy, reduced the combined endpoint of cardiovascular hospitalization or death from any cause by 24 percent when compared to placebo. This reduction was generally consistent across study subgroups based on baseline characteristics or medications. Patients taking Multaq had higher rates of diarrhea, nausea, bradycardia, QT-interval prolongation and cutaneous rash than patients taking placebo.

Initiation of Multaq treatment is contraindicated in patients with severe heart failure (NYHA class IV) or NYHA Class II-III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic. This unstable population corresponds to the population of the ANDROMEDA trial in which patients receiving dronedarone had a greater than two-fold increase in mortality compared to placebo.

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