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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Dronedarone in high-risk permanent atrial fibrillation
New England Journal of Medicine, Volume 365, No. 24, Year 2011
Notification
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Description
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.) Copyright © 2011 Massachusetts Medical Society. All rights reserved.
Authors & Co-Authors
Connolly, Stuart J.
Canada, Hamilton
Hamilton Health Sciences
Camm, A. John
United Kingdom, London
St George’s, University of London
Halperin, Jonathan Lee
United States, New York
The Mount Sinai Medical Center
Joyner, Campbell D.
Canada, Toronto
Sunnybrook Health Sciences Centre
Alings, Marco A.
Netherlands, Breda
Amphia Hospital
Amerena, John V.
Australia, Geelong
Kardinia House
Atar, Dan
Norway, Oslo
Oslo Universitetssykehus
Avezum, Álvaro Jr
Brazil, Sao Paulo
Estudios Clínicos Latinoamérica
Blomström, Per
Sweden, Uppsala
Akademiska Sjukhuset
Borggrefe, Martin M.
Germany, Mannheim
Universitätsklinikum Mannheim
Budaj, Andrzej J.
Poland, Warsaw
Szpital Grochowski, Warszawa
Chen, Shih Ann
Taiwan, Taipei
Taipei Veterans General Hospital
Ching, Chi Keong
Singapore, Singapore City
National Heart Centre Singapore
Commerford, Patrick Joseph
South Africa, Cape Town
University of Cape Town
Dans, Antonio L.L.
Philippines, Manila
Philippine General Hospital
Davy, Jean Marc
France, Montpellier
Centre Hospitalier Universitaire de Montpellier
Delacrétaz, Etienne
Switzerland, Bern
University Hospital Bern
Di Pasquale, Giuseppe And
Italy, Bologna
Ospedale Maggiore
Díaz, Rafaël J.
Argentina, Rosario
Estudios Clinicos Latinoamerica
Dorian, Paul
Canada, Toronto
Saint Michael's Hospital University of Toronto
Flaker, Greg C.
United States, Columbia
University of Missouri
Golitsyn, Sergey P.
Russian Federation, Moscow
National Medical Research Center of Cardiology of the Ministry of Healthcare of the Russian Federation
González-Hermosillo, Jesús Antonio
Mexico, Tlalpan
Instituto Nacional de Cardiologia Ignacio Chavez
Granger, Christopher B.
United States, Durham
Duke University Medical Center
Heidbuchel, H.
Belgium, Leuven
Ku Leuven– University Hospital Leuven
Kautzner, Josef
Czech Republic, Prague
Institutu Klinické a Experimentální Medicíny
Kim, June Soo
South Korea, Seoul
Samsung Medical Center, Sungkyunkwan University
Lanas, Fernando T.
Chile, Temuco
Universidad de la Frontera
Lewis, Basil S.
Israel, Haifa
Carmel Medical Center
Merino, José Luis
Spain, Madrid
Hospital Universitario la Paz
Morillo, Carlos A.
Canada, Hamilton
Hamilton Health Sciences
Murín, Ján
Slovakia, Bratislava
University Hospital in Bratislava
Narasimhan, Calambur
India, Hyderabad
Care Hospital Hyderabad
Paolasso, Ernesto Andrés C.
Argentina, Rosario
Instituto de Inmunología Clínica y Experimental de Rosario
Parkhomenko, Alexander N.
Ukraine, Kyiv
National Scientific Center M.d. Strazhesko Institute of Cardiology
Peters, Nicholas S.
United Kingdom, London
Imperial College London
Sim, Kui Hian
Malaysia, Kuching
Sarawak General Hospital
Stiles, Martin K.
New Zealand, Auckland
The University of Auckland
Tanomsup, Supachai
Thailand, Bangkok
Ramathibodi Hospital
Toivonen, Lauri K.
Finland, Helsinki
Helsinki University Hospital
Tomcsányi, Jànos
Hungary, Budapest
Buda Hospital of the Hospitaller Order of Saint John of God
Torp-Pedersen, Christian Tobias
Denmark, Copenhagen
Københavns Universitet
Tse, Hung Fat
Hong Kong
Queen Mary Hospital Hong Kong
Vardas, Panos E.
Greece, Heraklion
University of Crete Medical School
Vinereanu, Dragoș
Romania, Bucharest
Universitatea de Medicina si Farmacie Carol Davila Din Bucuresti
Xavier, Denis
India, Bengaluru
St. John's Medical College
Zhu, Jun
Unknown Affiliation
Zhu, Junren
China, Shanghai
Zhongshan Hospital
Baret-Cormel, Lydie
France, Gentilly
Sanofi S.a.
Weinling, E.
France, Gentilly
Sanofi S.a.
Staiger, Christoph
France, Gentilly
Sanofi S.a.
Yusuf, Salim N.
Canada, Hamilton
Hamilton Health Sciences
Chrolavicius, Susan
Canada, Hamilton
Hamilton Health Sciences
Afzal, Rizwan
Canada, Hamilton
Hamilton Health Sciences
Hohnloser, Stefan Hans
Germany, Frankfurt am Main
Goethe-universität Frankfurt am Main
Wyse, D. George
Unknown Affiliation
Cairns, J. A.
Unknown Affiliation
Pfeffer, Marc Allan
Unknown Affiliation
Pocock, Stuart J.
Unknown Affiliation
Wellens, Hein J.J.
Unknown Affiliation
Atra, M.
Unknown Affiliation
Basart, Dick C.G.
Unknown Affiliation
Bornstein, Natan M.
Unknown Affiliation
Brandes, A.
Unknown Affiliation
de Raedt, Herbert J.L.P.
Unknown Affiliation
Doiny, D.
Unknown Affiliation
Duray, Gabor Z.
Unknown Affiliation
Dvorakova, H.
Unknown Affiliation
Estrada, A.
Unknown Affiliation
Fodor, Jiri George
Unknown Affiliation
Gross, B.
Unknown Affiliation
Halon, David A.
Unknown Affiliation
Häppölä, O.
Unknown Affiliation
Hart, Robert G.
Unknown Affiliation
Healey, Jeff S.
Unknown Affiliation
Jacobsson, F.
Unknown Affiliation
Kalvach, Pavel
Unknown Affiliation
Krahn, Andrew D.
Unknown Affiliation
Laine, Mika K.
Unknown Affiliation
Maggioni, Aldo Pietro
Unknown Affiliation
Mairesse, Georges H.
Unknown Affiliation
Muir, Scott W.
Unknown Affiliation
Norrving, Bo
Unknown Affiliation
Peeters, André Philippe
Unknown Affiliation
Pizzolato, G.
Unknown Affiliation
Ruíz-Ares, Gerardo
Unknown Affiliation
Veltmann, Christian
Unknown Affiliation
Verdecchia, Paolo
Unknown Affiliation
Widimsky, Petr
Unknown Affiliation
Zaborski, J.
Unknown Affiliation
Zimlíchman, Reuven R.
Unknown Affiliation
Demaerschalk, Bart M.
Unknown Affiliation
Diener, Hans Christoph W.
Unknown Affiliation
Cundiff, David K.
Unknown Affiliation
Holmes, E.
Unknown Affiliation
Lawrence, M.
Unknown Affiliation
Bajkor, S.
Unknown Affiliation
McCready, Tara
Unknown Affiliation
Meeks, Brandi
Unknown Affiliation
Gao, Peggy
Unknown Affiliation
Statistics
Citations: 348
Authors: 100
Affiliations: 48
Identifiers
Doi:
10.1056/NEJMoa1109867
ISSN:
00284793
e-ISSN:
15334406
Research Areas
Environmental
Noncommunicable Diseases