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MULTAQ(R) (dronedarone) for Atrial Fibrillation or Atrial Flutter Now Available in the United States
Date:7/28/2009

AQ 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.

To ensure the use of MULTAQ in the appropriate patient population, sanofi-aventis U.S. LLC also announced the launch of mPACT MULTAQ((R)) Partnership for Appropriate Care and Treatment(TM), the Risk Evaluation and Mitigation Strategy (REMS). The mPACT Partnership was developed to assist healthcare professionals (HCPs) with the identification of appropriate patients and to ensure the safe use of MULTAQ while minimizing risk. The risk mitigation program consists of a Communication Plan for HCPs, a medication guide for patients and post-marketing surveillance.

There are approximately 2.5 million Americans with AF and the incidence is growing worldwide in relation to the aging population. Atrial fibrillation is a complex disease that increases the risk of stroke up to five-fold, worsens the prognosis of patients with cardiovascular risk factors, and doubles the risk of mortality.

About MULTAQ(R) (dronedarone)

MULTAQ, discovered and developed by sanofi-aventis, has been studied in a clinical development program involving nearly 6,300 patients including more than 3,200 patients who received MULTAQ. It represents one of the few new treatment options for AF/AFL patients in the last 10 years. MULTAQ is to be given twice daily as a 400 mg tablet and should be taken as one tablet with the morning and evening meals. Treat
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