NYMC Faculty Publications

Efficacy and Safety of Dronedarone in the Treatment of Patients With Atrial Fibrillation

Journal Title

Expert Opinion on Drug Safety

First Page


Last Page


Document Type


Publication Date





INTRODUCTION: Dronedarone, a derivative of amiodarone with structural modifications, was designed to have similar electrophysiological properties with a less toxic profile. Areas covered: Brief overview of the pharmacology of dronedarone followed by a summary of randomized clinical trials testing the efficacy of dronedarone in maintaining normal sinus rhythm and clinical outcomes associated with these trials. In depth discussion and commentary on trial findings which may seem contradictory at first approach and brief discussion of post-marketing surveillance studies. Expert opinion: Dronedarone is a moderately efficacious anti-arrhythmic agent which is safe for use in a carefully selected patient population, maintained in normal sinus rhythm, without advanced congestive heart failure, structural heart disease, permanent atrial fibrillation, digoxin use. It is especially useful in younger patients who lack other risk factors for cardiovascular events and, who stand to gain the most by avoiding long-term pulmonary and thyroid toxicities associated with more effective, but also significantly more toxic agents such as amiodarone.