Key result
Dronedarone 800 mg daily significantly increased the time to atrial fibrillation relapse compared to placebo (median 60 vs 5.3 days; RRR 55%, 95% CI 28-72%, P=0.001).
Why the study?
Does dronedarone prevent AF relapse in patients with persistent AF after cardioversion?
Population
270 patients with persistent AF (199 entered maintenance phase following pharmacological or DC cardioversion)
Comparison
Dronedarone 800 mg, 1200 mg, or 1600 mg daily vs Placebo
Design
RCT, randomly allocated
Follow-up
6 months
Authors
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Supports dronedarone to maintain sinus rhythm after cardioversion in persistent AF; confirms placebo-controlled efficacy with better tolerability than amiodarone.
RCT (n=270)
Randomized
Does dronedarone prevent AF relapse in patients with persistent AF after cardioversion?
Effect estimate: RRR 55% (95% CI 28 to 72%)
Absolute Event Rate: 60% vs 5.3%
p-value: p=0.001
Dronedarone at a dose of 800 mg daily is effective and safe for preventing AF relapses after cardioversion, notably lacking the thyroid and proarrhythmic side effects associated with amiodarone.
P Touboul (2003) conducted an RCT in Persistent atrial fibrillation (n=270). Dronedarone vs. Placebo was evaluated on Time to atrial fibrillation relapse (RRR 55%, 95% CI 28 to 72%, p=0.001). Dronedarone 800 mg daily significantly increased the time to atrial fibrillation relapse compared to placebo (median 60 vs 5.3 days; RRR 55%, 95% CI 28-72%, P=0.001).
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