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Effects of Dronedarone on Clinical Outcomes in Patients with Lone Atrial Fibrillation: Pooled Post Hoc Analysis from the ATHENA/EURIDIS/ADONIS Studies
Article first published online: 2 FEB 2011
© 2011 Wiley Periodicals, Inc.
Journal of Cardiovascular Electrophysiology
Volume 22, Issue 7, pages 770–776, July 2011
How to Cite
DURAY, G. Z., TORP-PEDERSEN, C., CONNOLLY, S. J. and HOHNLOSER, S. H. (2011), Effects of Dronedarone on Clinical Outcomes in Patients with Lone Atrial Fibrillation: Pooled Post Hoc Analysis from the ATHENA/EURIDIS/ADONIS Studies. Journal of Cardiovascular Electrophysiology, 22: 770–776. doi: 10.1111/j.1540-8167.2010.02006.x
The EURIDIS, ADONIS, and ATHENA trials were sponsored by Sanofi Aventis, Paris, France.
Dr. Duray reports lecture fees from Sanofi Aventis. Dr. Torp-Pedersen reports honoraria on relevant topics from Sanofi Aventis and Cardiome, as well as advisory committee and consultancy work for Sanofi Aventis, Cardiome, and Merck. Dr. Connolly reports participation on research grants supported by, and speaker and consultancy fees from, Sanofi Aventis. Dr. Hohnloser reports participation on research grants supported by, and consultancy fees from, Sanofi Aventis. He also reports speaker's fees relevant to this topic from Sanofi Aventis, St. Jude Medical, and Boehringer Ingelheim.
- Issue published online: 21 JUL 2011
- Article first published online: 2 FEB 2011
- Manuscript received 11 October 2010; Revised manuscript received 24 November 2010; Accepted for publication 7 December 2010.
- antiarrhythmic therapy;
- cardiovascular hospitalization;
- lone atrial fibrillation
Dronedarone in Lone Atrial Fibrillation. Introduction: Dronedarone has been shown to reduce cardiovascular hospitalizations or death in patients with atrial fibrillation (AF) and additional risk factors. This post hoc exploratory analysis examines its effects in the subgroup of lone AF patients.
Methods and Results: Individual data from patients with lone AF enrolled in the EURIDIS, ADONIS, and ATHENA trials were entered in a central database. The effects of dronedarone compared to placebo on the composite endpoint of cardiovascular hospitalizations or death, and their individual components, were evaluated. A total of 432 (192 placebo and 240 dronedarone) patients (7% of the total population) were classified as having lone AF (69.4% male patients, mean age 64 ± 13 years). The patients were followed for 13.8 ± 7.2 months. The risk for first cardiovascular hospitalizations or death from any cause in the placebo group after 1 year was 25% in the lone AF group compared to 29% the rest of the population. For patients with lone AF, dronedarone led to a 44% reduction of cardiovascular hospitalizations or death (hazard ratio (HR) 0.56; 95%CI 0.36–0.88, P = 0.004) and to a 46% reduction in cardiovascular hospitalizations alone (HR 0.54; 95%CI 0.34–0.87, P = 0.004) compared to placebo. HR for all-cause mortality was 1.02 (95%CI 0.31–3.34, P = 0.885). All findings were homogeneous across the 3 studies and similar to those observed in the overall population.
Conclusion: According to this post hoc analysis, patients with lone AF have a high risk for cardiovascular hospitalization within 1 year. Dronedarone when added to standard of care reduces the risk of cardiovascular hospitalizations in this population. (J Cardiovasc Electrophysiol, Vol. 22, pp. 770-776, July 2011)