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Drug Saf. 2013 Feb;36(2):93-110. doi: 10.1007/s40264-012-0012-8.

Benefit-risk assessment of dronedarone in the treatment of atrial fibrillation.

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  • 1University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Dudley Road, Birmingham B18 7QH, UK.


Rhythm control in atrial fibrillation (AF) can be achieved using pharmacological therapy. Amiodarone is the most efficacious anti-arrhythmic agent; however, its use is limited due to an unfavourable safety profile, including pro-arrhythmia, thyroid, liver, skin and pulmonary complications. Dronedarone, which is structurally similar to amiodarone, was developed to try and achieve a favourable balance of efficacy and risk. Dronedarone has been evaluated in several large clinical trials, which have shown reduced mortality and hospitalization rates in patients with non-permanent AF. In patients with permanent AF and/or heart failure, dronedarone has been shown to cause increased mortality and morbidity and should not be used in these groups. Compared with amiodarone, dronedarone has fewer toxic effects (thyroid, skin, pulmonary) and, although less efficacious, may be used as first-line therapy for maintenance of sinus rhythm in patients with non-permanent AF. Clinicians must be vigilant in monitoring their patients to ensure they do not develop permanent AF or heart failure.

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