Dronedarone in high-risk permanent atrial fibrillation

Connolly, Stuart J., Camm, A. John, Halperin, Jonathan L., Joyner, Campbell, Alings, Marco, Amerena, John, Atar, Dan, Avezum, Alvaro, Blomstroem, Per, Borggrefe, Martin, Budaj, Andrzej, Chen, Shih-Ann, Ching, Chi Keong, Commerford, Patrick, Dans, Antonio, Davy, Jean-Marc, Delacretaz, Etienne, Di Pasquale, Giuseppe, Diaz, Rafael, Dorian, Paul, Flaker, Greg, Golitsyn, Sergey, Gonzalez-Hermosillo, Antonio, Granger, Christopher B., Heidbuechel, Hein, Kautzner, Josef, Kim, June Soo, Lanas, Fernando, Lewis, Basil S., Merino, Jose L., Morillo, Carlos, Murin, Jan, Narasimhan, Calambur, Paolasso, Ernesto, Parkhomenko, Alexander, Peters, Nicholas S., Sim, Kui-Hian, Stiles, Martin K., Tanomsup, Supachai, Toivonen, Lauri, Tomcsanyi, Janos, Torp-Pedersen, Christian, Tse, Hung-Fat, Vardas, Panos, Vinereanu, Dragos, Xavier, Denis, Zhu, Jun, Zhu, Jun-Ren, Baret-Cormel, Lydie, Weinling, Estelle, Staiger, Christoph, Yusuf, Salim, Chrolavicius, Susan, Afzal, Rizwan, Hohnloser, Stefan H., The PALLAS Investigators and Colquhoun, D. (2011) Dronedarone in high-risk permanent atrial fibrillation. New England Journal of Medicine, 365 24: 2268-2276. doi:10.1056/NEJMoa1109867

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Author Connolly, Stuart J.
Camm, A. John
Halperin, Jonathan L.
Joyner, Campbell
Alings, Marco
Amerena, John
Atar, Dan
Avezum, Alvaro
Blomstroem, Per
Borggrefe, Martin
Budaj, Andrzej
Chen, Shih-Ann
Ching, Chi Keong
Commerford, Patrick
Dans, Antonio
Davy, Jean-Marc
Delacretaz, Etienne
Di Pasquale, Giuseppe
Diaz, Rafael
Dorian, Paul
Flaker, Greg
Golitsyn, Sergey
Gonzalez-Hermosillo, Antonio
Granger, Christopher B.
Heidbuechel, Hein
Kautzner, Josef
Kim, June Soo
Lanas, Fernando
Lewis, Basil S.
Merino, Jose L.
Morillo, Carlos
Murin, Jan
Narasimhan, Calambur
Paolasso, Ernesto
Parkhomenko, Alexander
Peters, Nicholas S.
Sim, Kui-Hian
Stiles, Martin K.
Tanomsup, Supachai
Toivonen, Lauri
Tomcsanyi, Janos
Torp-Pedersen, Christian
Tse, Hung-Fat
Vardas, Panos
Vinereanu, Dragos
Xavier, Denis
Zhu, Jun
Zhu, Jun-Ren
Baret-Cormel, Lydie
Weinling, Estelle
Staiger, Christoph
Yusuf, Salim
Chrolavicius, Susan
Afzal, Rizwan
Hohnloser, Stefan H.
The PALLAS Investigators
Colquhoun, D.
Title Dronedarone in high-risk permanent atrial fibrillation
Journal name New England Journal of Medicine   Check publisher's open access policy
ISSN 0028-4793
1533-4406
Publication date 2011-12-15
Sub-type Article (original research)
DOI 10.1056/NEJMoa1109867
Open Access Status File (Publisher version)
Volume 365
Issue 24
Start page 2268
End page 2276
Total pages 9
Place of publication Waltham, United States
Publisher Massachusetts Medical Society
Language eng
Formatted abstract
BACKGROUND: Dronedarone restores sinus rhythm and reduces hospitalization or death in intermittent atrial fibrillation. It also lowers heart rate and blood pressure and has antiadrenergic and potential ventricular antiarrhythmic effects. We hypothesized that dronedarone would reduce major vascular events in high-risk permanent atrial fibrillation.
METHODS: We assigned patients who were at least 65 years of age with at least a 6-month history of permanent atrial fibrillation and risk factors for major vascular events to receive dronedarone or placebo. The first coprimary outcome was stroke, myocardial infarction, systemic embolism, or death from cardiovascular causes. The second coprimary outcome was unplanned hospitalization for a cardiovascular cause or death.
RESULTS: After the enrollment of 3236 patients, the study was stopped for safety reasons. The first coprimary outcome occurred in 43 patients receiving dronedarone and 19 receiving placebo (hazard ratio, 2.29; 95% confidence interval [CI], 1.34 to 3.94; P = 0.002). There were 21 deaths from cardiovascular causes in the dronedarone group and 10 in the placebo group (hazard ratio, 2.11; 95% CI, 1.00 to 4.49; P = 0.046), including death from arrhythmia in 13 patients and 4 patients, respectively (hazard ratio, 3.26; 95% CI, 1.06 to 10.00; P = 0.03). Stroke occurred in 23 patients in the dronedarone group and 10 in the placebo group (hazard ratio, 2.32; 95% CI, 1.11 to 4.88; P = 0.02). Hospitalization for heart failure occurred in 43 patients in the dronedarone group and 24 in the placebo group (hazard ratio, 1.81; 95% CI, 1.10 to 2.99; P = 0.02). CONCLUSIONS: Dronedarone increased rates of heart failure, stroke, and death from cardiovascular causes in patients with permanent atrial fibrillation who were at risk for major vascular events. Our data show that this drug should not be used in such patients. (Funded by Sanofi-Aventis; PALLAS ClinicalTrials.gov number, NCT01151137.) 
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
 
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