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:

• Dronedarone (Multaq) to cost $9/day (July 28, 2009)
• Dronedarone approved by FDA for atrial fibrillation or atrial flutter (July 2, 2009)
• Dronedarone debut: will it be successful? (April 29, 2009)
• Dronedarone gets cautious nod from FDA advisory panel (March 18, 2009)
• FDA reviewers give green light for dronedarone (March 16, 2009)
• ATHENA published in NEJM: dronedarone benefits AF patients (February 11, 2009)

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