Key result
Dronedarone was evaluated by an FDA advisory committee for the reduction of cardiovascular morbidity and mortality among patients with atrial fibrillation or atrial flutter.
Discusses the FDA advisory committee's consideration of dronedarone for reducing cardiovascular morbidity and mortality in patients with atrial fibrillation or flutter.
On March 18, 2009, the Cardiovascular and Renal Drugs Advisory Committee of the Food and Drug Administration (FDA) convened to determine whether the antiarrhythmic drug dronedarone should be approved for the reduction of cardiovascular morbidity and mortality among patients with atrial fibrillation or atrial flutter. It has been 10 years since the FDA approved dofetilide, the last antiarrhythmic drug for suppression of atrial fibrillation to reach the U.S. market. Because of an increased risk of torsades de pointes, particularly at the initiation of therapy, dofetilide's label includes a requirement that therapy be initiated in the hospital and monitored by a . . .
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Peter Zimetbaum (2009) conducted an editorial in Atrial fibrillation or atrial flutter. Dronedarone was evaluated on Reduction of cardiovascular morbidity and mortality. Dronedarone was evaluated by an FDA advisory committee for the reduction of cardiovascular morbidity and mortality among patients with atrial fibrillation or atrial flutter.
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