Dronedarone is a multi-channel blocking, anti-arrhythmic benzofuran derivative. Dronedarone is licensed for clinically stable adult patients with a history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate.

There are 7 efficacy trials, 6 have been fully published and two combined into one publication.  The 6 month active comparator trial with amiodarone (DIONYSOS) is yet to be fully published. Dronedarone is less effective than amiodarone, as shown by the results of the DIONYSOS trial and probably more effective than other anti-arrhythmic drugs but direct head to head comparisons are not available.

Dronedarone is associated with fewer side effects leading to discontinuation compared with amiodarone. No excess thyroid or pulmonary toxicity, photosensitivity or pro-arrhythmic events have been identified in the published clinical trials.

NICE have issued a second appraisal consultation document (ACD) on the use of dronedarone for AF. The first ACD, issued in January 2010, did not recommend use of dronedarone on the grounds of cost effectiveness.  The second ACD recommends dronedarone as an option for the treatment of non-permanent AF under certain circumstances. A single technology appraisal (STA) on dronedarone is anticipated in Q2 -3 2010.