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FDA Approves Dronedarone for Atrial Fibrillation or Atrial Flutter
NEW YORK -- July 2, 2009 -- The US Food and Drug Administration (FDA) has approved dronedarone (Multaq) 400 mg tablets to reduce cardiovascular hospitalisation in patients with atrial fibrillation (AF) or atrial flutter (AFL).
The approval was based on a placebo-controlled, double-blind, parallel arm trial assessing the efficacy of dronedarone 400 mg BID for the prevention of cardiovascular hospitalisation or death from any cause in patients with atrial fibrillation/atrial flutter (ATHENA).
Results showed that dronedarone 400 mg BID, in addition to standard therapy, reduced the combined endpoint of cardiovascular hospitalisation or death from any cause by 24% (P < .001) when compared with placebo.
The reduction was generally consistent across study subgroups based on baseline characteristics or medications.
Patients taking dronedarone had higher rates of diarrhoea, nausea, bradycardia, QT-interval prolongation, and cutaneous rash than patients taking placebo.
Dronedarone is contraindicated in patients with severe heart failure (NYHA class 5) or NYHA Class 2 to 3 heart failure with a recent decompensation requiring hospitalisation or referral to a specialised heart failure clinic.
This unstable population corresponds to the population of the Antiarrhythmic Trial With Dronedarone in Moderate-to-Severe Congestive Heart Failure Evaluating Morbidity Decrease (ANDROMEDA) in which patients receiving dronedarone had a greater than 2-fold increase in mortality compared with placebo.
SOURCE: Sanofi-Aventis
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