Multaq approved for A-Fib.(NEWS FROM THE FDA)(Brief article)

The Food and Drug Administration has approved dronedarone to help maintain normal heart rhythms in outpatients with a history of atrial fibrillation or atrial flutter.

The agency approved the drug with the stipulation that its manufacturer, Sanofi-Aventis, launch a Risk Evaluation and Mitigation Strategy aimed at educating health care providers about who should receive the agent. Appropriate patients include those "whose hearts have returned to normal rhythm or who will undergo drug or electric-shock treatment to restore a normal heartbeat," according to a statement from the FDA. Dronedarone is contraindicated in patients with severe heart failure.

The approval was largely based on results from the multinational ATHENA trial, which compared 400 mg of dronedarone twice a day to placebo in 4,628 patients with at least one episode of atrial fibrillation or atrial flutter and at least one normal ECG during the previous 6 months.

After 2 years, treatment with dronedarone was associated with a 24% reduction in time to first cardiovascular hospitalization or all-cause death, a highly statistically significant difference. But most of the benefit was due to the difference in cardiac hospitalizations, and nearly all of that effect was due to hospitalizations for atrial fibrillation.

Dronedarone, which will be marketed as Multaq, is similar to amiodarone, but is not associated with the older agent's pulmonary and thyroid toxicity.

"Multaq is the first drug approved in the United States that has shown a clinical benefit to reduce cardiovascular hospitalization in patients with" atrial fibrillation or atrial flutter, according to a statement from Sanofi-Aventis.

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