A review of the evidence for dronedarone in the Drug and Therapeutics Bulletin (D&TB) concludes that for a number of reasons its use in patients with non-permanent atrial fibrillation (AF) in place of existing anti-arrhythmic drugs cannot be recommended.

The review briefly describes AF and its treatment, which aims to reduce the risk of stroke associated with the condition and to control the arrhythmia itself: this may involve controlling either the rhythm itself or limiting the ventricular rate. Several drugs are used for rhythm control, the most effective, but most toxic, being amiodarone. Dronedarone is structurally  and pharmacologically similar to amiodarone but contains no iodine atoms; and has a much shorter half-life (about 1 day vs. about 50 days).

Evidence for clinical efficacy comes mainly from placebo-controlled trials, and there is only one published comparison with another anti-arrhythmic drug (amiodarone). In the comparative trial, dronedarone appeared somewhat less effective than amiodarone. A pooled analysis of placebo-controlled trials of dronedarone and amiodarone concluded that dronedarone was less effective, however this analysis should be taken with caution as patient populations were different. Adverse effect data suggest that dronedarone is somewhat better tolerated than amiodarone.

Overall, the authors conclude that dronedarone is effective in controlling rhythm in patients with non-permanent AF, however it seems to be less effective than amiodarone. Its adverse effect profile is different to that of amiodarone, but there are no data on its long term safety. Based on this, its contra-indications, lack of comparisons with other anti-arrhythmic drugs, and much greater expense, the authors conclude that its use in patients with non-permanent AF in place of other anti-arrhythmic drugs cannot be recommended.