Dronedarone for Maintenance of Sinus Rhythm in Atrial Fibrillation or Flutter
Key result
Dronedarone prolonged the median time to recurrence of atrial fibrillation or flutter compared to placebo in the European (96 vs 41 days, P=0.01) and non-European trials (158 vs 59 days, P=0.002).
Why the study?
Does dronedarone prevent the recurrence of atrial fibrillation or flutter in patients with atrial fibrillation or flutter?
Population
1,237 patients with atrial fibrillation or flutter
Comparison
Dronedarone 400 mg twice daily vs Placebo
Design
RCT, randomized, double-blind
Follow-up
12 months
Authors
Discussion
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Implication
Supports dronedarone for rhythm control in AF; confirms efficacy versus placebo in two RCTs.
Study Design
Type
RCT (n=1,237)
Blinding
double-blind
Randomization
randomized
Multicenter
Yes
Structured PICO
Does dronedarone prevent the recurrence of atrial fibrillation or flutter in patients with atrial fibrillation or flutter?
P
Population
1,237 patients with atrial fibrillation or flutter
I
Intervention
Dronedarone 400 mg twice daily
C
Comparator
Placebo
O
Outcome
Time to the first recurrence of atrial fibrillation or fluttersurrogate
Main Result
p-value: p=0.01 and 0.002
Dronedarone 400 mg twice daily significantly prolongs the time to recurrence of atrial fibrillation or flutter and reduces ventricular rate during recurrence compared to placebo.
Cite This Study
Singh et al. (2007) conducted an RCT in Atrial Fibrillation or Flutter (n=1,237). Dronedarone vs. Placebo was evaluated on time to the first recurrence of atrial fibrillation or flutter (p=0.01 and 0.002). Dronedarone prolonged the median time to recurrence of atrial fibrillation or flutter compared to placebo in the European (96 vs 41 days, P=0.01) and non-European trials (158 vs 59 days, P=0.002).