Dronedarone (Multaq) less effective but safer than amiodarone, study suggests

Dronedarone (Multaq, Sanofi-aventis) is less effective than amiodarone in fighting AF but causes fewer adverse effects, according to a new study.

“The critical question for clinical practice,” the study authors write, is whether the safety benefits “justify a retreat from the moderate efficacy afforded by amiodarone.”

In a systematic overview of randomized trials published in the Journal of the American College of Cardiology, Piccini and colleagues at Duke University identified 4 placebo-controlled trials of dronedarone, 4 placebo-controlled trials of amiodarone, and 1 trial of dronedarone versus amiodarone. For every 1,000 patients treated with dronedarone instead of amiodarone, the Duke investigators calculated there would be about 228 more AF recurrences, 9.6 fewer deaths, and 62 fewer adverse events requiring drug discontinuation.

Clinicians are faced with a difficult dilemma, write Paul Chan and colleagues in an accompany editorial. Amiodarone in AF has not been well studied and does not have an approved FDA indication for AF, yet more than two millions amiodarone prescriptions are filled each year for AF, despite its serious and well known side effect profile.

Chan et al note that in the absence of adequately powered and designed randomized trials comparing amiodarone and dronedarone, the Duke analysis should be considered “hypothesis generating.”

In the meantime,” they write, “clinicians will need to balance whether the use of dronedarone, a less efficacious but possibly safer antiarrhythmic drug than amiodarone (in patients without reduced ejection fraction), is justified for their patients with AF.”

Here is recent CardioBrief coverage of dronedarone:


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  1. […] received approval for the indication of atrial fibrillation in the European Union. Dronedarone was approved in the US last July. (Click here for our previous coverage of […]

  2. […] Flip the Switch By Steve Nobody likes Amiodarone, not even the doctors who prescribe it. I recently wrote a post about it and all the side effects it can cause. A newer drug, Dronedarone, is usually recommended for younger patients. The longer you are on Amiodarone, the better the chances that the side effects will show. Dronedarone isn’t as effective as Amiodrone in controlling Atrial Fibrillation, but has less side effects. […]

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