drugset / Trial / NCT00489736
Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation
RandomizedParallel-groupTriple-blindTreatment
Summary
The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.
Timeline
- Start
- 2007-06
- Primary completion
- 2008-10
- Completion
- 2008-10
Outcome
Missed primary endpoint
registry Dronedarone 400mg Bid vs Amiodarone 600mg/200mg od; p <0.0001; Hazard Ratio (HR) 1.59 (95% CI 1.28 to 1.98) NCT00489736 ↗
paper The primary composite endpoint was 75.1 and 58.8% with dronedarone and amiodarone, respectively, at 12 months PMID 20384650 ↗
paper In this short-term study, dronedarone was less effective than amiodarone in decreasing AF recurrence PMID 20384650 ↗
Publications
- Le Heuzey JY, De Ferrari GM, Radzik D, Santini M, Zhu J, Davy JM. 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. J Cardiovasc Electrophysiol. 2010 Jun 1;21(6):597-605. doi: 10.1111/j.1540-8167.2010.01764.x. Epub 2010 Apr 6.
- Ezekowitz MD. Maintaining sinus rhythm--making treatment better than the disease. N Engl J Med. 2007 Sep 6;357(10):1039-41. doi: 10.1056/NEJMe078148. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amiodarone | Small molecule | 200 mg | Oral |
| Subject | Dronedarone | Small molecule | 400 mg | Oral |