A Short-Term, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Dronedarone versus Amiodarone in Patients with Persistent Atrial Fibrillation: The DIONYSOS Study

Dronedarone versus Amiodarone in Patients with AF.  Introduction: We compared the efficacy and safety of amiodarone and dronedarone in patients with persistent atrial fibrillation (AF). Methods: Five hundred and four amiodarone‐naïve patients were randomized to receive dronedarone 400 mg bid (n = 24...

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Published in:Journal of cardiovascular electrophysiology 2010-06, Vol.21 (6), p.597-605
Main Authors: LE HEUZEY, JEAN-YVES, DE FERRARI, GAETANO M., RADZIK, DAVID, SANTINI, MASSIMO, ZHU, JUNREN, DAVY, JEAN-MARC
Format: Article
Language:English
Subjects:
Aged
amiodarone
Amiodarone - adverse effects
Amiodarone - analogs & derivatives
Amiodarone - therapeutic use
Anti-Arrhythmia Agents - adverse effects
Anti-Arrhythmia Agents - therapeutic use
atrial fibrillation
Atrial Fibrillation - drug therapy
clinical trials
Double-Blind Method
dronedarone
Electrocardiography - drug effects
Endpoint Determination
Female
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Nervous System Diseases - chemically induced
Risk Assessment
Thyroid Diseases - chemically induced
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Summary:Dronedarone versus Amiodarone in Patients with AF.  Introduction: We compared the efficacy and safety of amiodarone and dronedarone in patients with persistent atrial fibrillation (AF). Methods: Five hundred and four amiodarone‐naïve patients were randomized to receive dronedarone 400 mg bid (n = 249) or amiodarone 600 mg qd for 28 days then 200 mg qd (n = 255) for at least 6 months. Primary composite endpoint was recurrence of AF (including unsuccessful electrical cardioversion, no spontaneous conversion and no electrical cardioversion) or premature study discontinuation. Main safety endpoint (MSE) was occurrence of thyroid‐, hepatic‐, pulmonary‐, neurologic‐, skin‐, eye‐, or gastrointestinal‐specific events, or premature study drug discontinuation following an adverse event. Results: Median treatment duration was 7 months. The primary composite endpoint was 75.1 and 58.8% with dronedarone and amiodarone, respectively, at 12 months (hazard ratio [HR] 1.59; 95% confidence interval [CI] 1.28–1.98; P < 0.0001), mainly driven by AF recurrence with dronedarone compared with amiodarone (63.5 vs 42.0%). AF recurrence after successful cardioversion was 36.5 and 24.3% with dronedarone and amiodarone, respectively. Premature drug discontinuation tended to be less frequent with dronedarone (10.4 vs 13.3%). MSE was 39.3 and 44.5% with dronedarone and amiodarone, respectively, at 12 months (HR = 0.80; 95% CI 0.60–1.07; P = 0.129), and mainly driven by fewer thyroid, neurologic, skin, and ocular events in the dronedarone group. Conclusion: In this short‐term study, dronedarone was less effective than amiodarone in decreasing AF recurrence, but had a better safety profile, specifically with regard to thyroid and neurologic events and a lack of interaction with oral anticoagulants. (J Cardiovasc Electrophysiol, Vol. 21, pp. 597‐605, June 2010)
ISSN:1045-3873
1540-8167
DOI:10.1111/j.1540-8167.2010.01764.x