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CLINICAL RESEARCH: HEART RHYTHM DISORDER

Comparative Efficacy of Dronedarone and Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation

Division of Cardiology, Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina

Manuscript received March 13, 2009; revised manuscript received April 22, 2009, accepted April 28, 2009.

^_* Reprint requests and correspondence: Dr. Jonathan P. Piccini, Duke Clinical Research Institute, Duke University Medical Center #31115, Durham, North Carolina 27710 (Email: jonathan.piccini{at}duke.edu).

Objectives: We sought to compare the efficacy and safety of dronedarone versus amiodarone for the prevention of recurrent atrial fibrillation (AF).

Background: Dronedarone is a noniodinated amiodarone congener developed to maintain sinus rhythm. Few data are available to directly compare the efficacy and safety of dronedarone versus amiodarone.

Methods: We conducted a systematic overview of all randomized controlled trials in which the authors evaluated dronedarone or amiodarone for the prevention of AF. The effect of amiodarone versus dronedarone was summarized by the use of indirect comparison meta-analysis and normal logistic meta-regression models.

Results: We identified 4 placebo-controlled trials of dronedarone, 4 placebo-controlled trials of amiodarone, and 1 trial of dronedarone versus amiodarone. By using random-effects modeling, we found that there was a significant estimated reduction in recurrent AF with amiodarone versus placebo (odds ratio [OR]: 0.12; 95% confidence interval [CI]: 0.08 to 0.19) but not dronedarone versus placebo (OR: 0.79; 95% CI: 0.33 to 1.87). A normal logistic regression model incorporating all trial evidence found amiodarone superior to dronedarone (OR: 0.49; 95% CI: 0.37 to 0.63; p < 0.001) for the prevention of recurrent AF. In contrast, these models also found a trend toward greater all-cause mortality (OR: 1.61; 95% CI: 0.97 to 2.68; p = 0.066) and greater overall adverse events requiring drug discontinuation with amiodarone versus dronedarone (OR: 1.81; 95% CI: 1.33 to 2.46; p < 0.001).

Conclusions: Dronedarone is less effective than amiodarone for the maintenance of sinus rhythm, but has fewer adverse effects. For every 1,000 patients treated with dronedarone instead of amiodarone, we estimate approximately 228 more recurrences of AF in exchange for 9.6 fewer deaths and 62 fewer adverse events requiring discontinuation of drug.

Key Words: dronedarone • amiodarone • antiarrhythmic drug therapy • atrial fibrillation

Abbreviations and Acronyms   AF = atrial fibrillation   CI = confidence interval   OR = odds ratio

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