Dronedarone in high-risk permanent atrial fibrillation

Stuart J. Connolly, A. John Camm, Jonathan L. Halperin, Campbell Joyner, Marco Alings, John Amerena, Dan Atar, Álvaro Avezum, Per Blomström, Martin Borggrefe, Andrzej Budaj, Shih Ann Chen, Chi Keong Ching, Patrick Commerford, Antonio Dans, Jean Marc Davy, Etienne Delacrétaz, Giuseppe Di Pasquale, Rafael Diaz, Paul DorianGreg Flaker, Sergey Golitsyn, Antonio Gonzalez-Hermosillo, Christopher B. Granger, Hein Heidbüchel, Josef Kautzner, June Soo Kim, Fernando Lanas, Basil S. Lewis, Jose L. Merino, Carlos Morillo, Jan Murin, Calambur Narasimhan, Ernesto Paolasso, Alexander Parkhomenko, Nicholas S. Peters, Kui Hian Sim, Martin K. Stiles, Supachai Tanomsup, Lauri Toivonen, János Tomcsányi, Christian Torp-Pedersen, Hung Fat Tse, Panos Vardas, Dragos Vinereanu, Denis Xavier, Jun Zhu, Jun Ren Zhu, Lydie Baret-Cormel, Estelle Weinling, Christoph Staiger, Salim Yusuf, Susan Chrolavicius, Rizwan Afzal, Stefan H. Hohnloser, D. G. Wyse, J. Cairns, M. Pfeffer, S. Pocock, H. Wellens, M. Atra, D. C. Basart, N. M. Bornstein, A. Brandes, H. De Raedt, D. Doiny, G. Z. Duray, H. Dvorakova, A. Estrada, G. Fodor, B. Gross, D. Halon, O. Häppölä, R. Hart, J. S. Healey, F. Jacobsson, P. Kalvach, A. Krahn, M. Laine, A. P. Maggioni, G. H. Mairesse, S. W. Muir, B. Norrving, A. Peeters, G. Pizzolato, G. Ruiz-Ares, C. Veltmann, P. Verdecchia, P. Widimsky, J. Zaborski, R. Zimlichman, B. Demaerschalk, H. C. Diener, D. Tirschwell, E. Holmes, M. Lawrence, S. Bajkor, T. McCready, B. Meeks, P. Gao, J. Smith, X. Yang, F. Yuan, L. Blake, V. Dunlop, Z. Gasic, S. Molnar, R. Nieuwlaat, E. Pasadyn, J. Sephton, R. Tuhy, M. Wild, A. Caccavo, L. R. Cartasegna, C. A. Cuneo, M. A. Garrido, L. A. Guzman, M. A. Hominal, J. R. Llanos, I. J. MacKinnon, M. L. Vico, D. R. Vogel, C. J. Zaidman, D. Colquhoun, J. T. Counsell, F. J. de Looze, V. K. Durbidge, P. W. Purnell, A. L. Soward, W. J. van Gaal, M. William, D. Burkart-Kuettner, K. Huber, B. Pieske, F. X. Roithinger, E. M. Catez, F. J. Cools, L. De Roy, P. De Vusser, L. De Wolf, O. Deceuninck, D. Dilling-Boer, M. P. Goethals, G. Paparella, F. Provenier, C. Scavée, G. Vervoort, R. V. Botelho, J. S. Braga, A. A. de Paola, W. K. de Souza, P. R. Genta, M. E. Hernandes, J. Jaber, A. M. Lorga-Filho, E. R. Manenti, J. C. Jorge, D. B. Précoma, G. Reis, P. R. Rossi, A. C. Sousa, S. L. Zimmermann, N. I. Gronkova, H. S. Tumbev, S. Bose, P. Boucher, J. Y. Cha, C. M. Constance, P. Costi, B. Coutu, M. Gupta, S. Kouz, A. S. Lam, R. Leather, A. S. Pandey, T. Rebane, D. Savard, R. St-Hilaire, S. Vizel, J. L. Cobos, R. Corbalan, H. Donoso, E. Escobar, M. E. Medina, S. H. Potthoff, C. A. Raffo, J. G. Saavedra, M. A. Tijerino, L. Ballek, P. Boček, M. Choura, V. Dědek, A. Egert, M. Hudcovic, Z. Klimsa, R. Labrova, J. Malecha, I. Petrova, I. Podpera, Z. Poklopová, T. Velimsky, U. Dixen, K. Egstrup, L. Frost, G. Gislason, S. E. Husted, T. J. Jakobsen, J. Jeppesen, K. Kaae Dodt, K. K. Klarlund, T. M. Melchior, H. Nielsen, K. Skagen, A. Aro, H. V. Huikuri, V. Kyto, K. Nyman, S. Utriainen, A. Ylitalo, R. Fouche, K. Gacem, M. Mansour, J. L. Pasquie, J. E. Poulard, K. F. Appel, C. Axthelm, R. F. Bosch, P. Bushoven, H. Darius, G. C. Grönefeld, C. Hanefeld, W. Haverkamp, T. Horacek, C. W. Israel, H. Killat, T. Klingenheben, J. Kreuzer, M. Leicht, M. B. Licka, M. Niethammer, W. A. Rieker, P. Salbach, I. Schenkenberger, A. Schmidt, S. G. Spitzer, N. Toursarkissian, R. Veltkamp, M. Weissbrodt, B. R. Winkelmann, J. Wurziger, C. Zemmrich, I. A. Vogiatzis, C. W. Siu, G. Ferencz, A. Katona, K. Keltai, Z. Kovács, Z. Laszlo, F. Poor, I. Szakal, E. Toldy-Schedel, A. Vertes, M. Eldar, M. Elias, N. A. Freedberg, S. Halabi, S. Hamoud, A. Katz, E. E. Klainman, A. Marmor, A. Medina, M. Mosseri, M. Motro, G. Y. Stein, T. Weiss, D. Zeltser, D. Calabrese, F. Cosmi, F. de Tommasi, N. Glorioso, M. M. Gulizia, M. Mennuni, G. Piovaccari, K. H. Chee, M. A. Alcocer Gamba, R. Alvarado-Ruiz, J. L. Arenas, E. Bayram Llamas, C. G. Calvo Vargas, J. Carrillo, P. Fernandez-Bonetti, J. F. Gomez, G. Llamas-Esperón, E. Lopez Rosas, N. Matadamas Hernandez, J. M. Ramirez Isunza, E. Salcido, R. G. Velasco-Sanchez, G. L. Bartels, F. Bracke, T. A. Bruning, L. Cozijnsen, G. J. de Weerd, F. R. den Hartog, H. Geertman, K. Hamraoui, W. F. Heesen, I. Hunze, H. H. Idzerda, J. Kragten, A. H. Liem, D. J. Lok, A. Moens, J. Plomp, L. Pos, A. R. Ramdat Misier, J. J. Remmen, J. H. Ruiter, M. F. Scholten, H. P. Swart, J. G. Tans, L. Theunissen, R. Tukkie, R. van der Heijden, D. J. Van Doorn, I. C. Van Gelder, M. W. van Hessen, P. H. Westendorp, A. R. Willems, S. K. Zoet-Nugteren, S. A. Aitken, J. M. Elliott, J. E. Scales, B. Scott, I. F. Ternouth, J. Tisch, J. Berg-Johansen, M. A. Husvik, H. Istad, K. Risberg, R. Rød, P. A. Sirnes, G. K. Skjelvan, J. Bednarski, M. Bronisz, L. Bryniarski, J. R. Gniot, T. Kawka-Urbanek, J. Kopaczewski, P. Miekus, T. J. Pasierski, M. Piepiorka, F. Prochaczek, G. Raczak, J. Rekosz, J. Stepinska, R. Szelemej, M. Szpajer, B. Zaborska, M. A. Cinteza, A. O. Ciobanu, A. R. Dan, D. Dimulescu, C. G. Fierbinteanu-Braticevici, O. Istratoaie, D. F. Lighezan, B. Minescu, M. M. Vintila, N. M. Akhmedzhanov, B. A. Alikhanov, A. V. Barabashkina, O. Barbarash, V. B. Barbarich, B. Y. Bart, M. V. Boyarkin, N. N. Burova, L. Bychkova, S. B. Fitilev, T. P. Gizatulina, L. A. Khaisheva, V. O. Konstantinov, N. Koziolova, V. Lesnov, Y. Lukyanov, N. P. Lyamina, T. A. Malkina, O. N. Miller, V. Moiseev, N. V. Novikova, O. V. Orlikova, V. A. Orlov, M. F. Osipenko, E. Panchenko, D. Y. Platonov, S. V. Popov, V. V. Rafalakiy, M. Y. Ruda, S. A. Seliverstova, S. V. Shalaev, V. V. Shchekotov, Y. Shubik, Y. Shvarts, V. A. Sulimov, T. V. Tretyakova, S. Vaniev, A. Vishnevsky, V. V. Yakusevich, S. S. Yakushin, K. N. Zrazhevskiy, W. S. Teo, V. Bugan, G. Kaliská, M. Masarovičová, J. Nociar, D. Pella, R. Uhliar, M. Bushidi, J. M. Engelbrecht, A. M. Okreglicki, T. Pillay, F. A. Snyders, H. D. Theron, T. P. Venter, J. G. Cho, D. Kim, Y. H. Kim, M. H. Lee, S. Oh, Y. K. On, T. H. Rho, D. H. Shin, J. Alzueta, J. Bruguera, S. Castrejon, E. Díaz-Infante, L. Grigorian Shamagian, A. Martínez-Rubio, L. Mont, M. Vida, X. Viñolas, S. T. Berglund, C. Blomstrom-Lundqvist, P. Cherfan, S. Jakobsson, L. Johansson, T. Juhlin, P. Kozak, F. Rönn, M. Rosenqvist, L. Sprock, A. F. Gallino, P. A. Lyrer, T. Moccetti, M. C. Chen, Y. F. Hu, Jiunn-Lee Lin, M. S. Wen, O. I. Karpenko, S. Kozhukhov, I. Kraiz, S. S. Pavlyk, P. I. Potapenko, O. V. Prokhorov, I. V. Prudkyi, V. Y. Prykhodko, L. V. Rudenko, O. S. Sychov, V. I. Tseluyko, V. A. Vizir, O. J. Zharinov, R. Aggarwal, A. J. Copley, P. P. Davey, H. H. Kadr, G. Y. Lip, S. Lord, A. J. Moriarty, M. P. Pye, A. D. Ryding, I. Savelieva, R. Abadier, S. Ahmad, Z. M. Ahmad, K. P. Alexander, A. D. Alfieri, S. Baker, E. M. Ball, L. Baruch, R. P. Bellam, S. A. Benjamin, D. A. Brill, K. F. Browne, J. T. Call, K. W. Carr, H. Chandna, C. Chen, Y. C. Chen, V. S. Chilakapati, D. Colan, S. F. Cossu, J. Dean, S. P. DeFehr, S. J. Dempsey, V. S. Desai, M. L. Dohrmann, H. S. Ellison, G. Emlein, N. Farris, R. H. Fields, G. J. Fishbein, E. A. Flores, I. R. Friedlander, M. D. Gelernt, H. C. Genovely, E. L. Gillespie, B. M. Go, D. W. Gottlieb, P. G. Grena, T. Guarnieri, D. K. Gupta, A. A. Haidar, G. S. Hamroff, J. L. Hargrove, E. J. Haskel, S. E. Hearne, D. A. Henderson, J. M. Herre, W. R. Herzog, B. L. Hoppe, D. Hotchkiss, D. J. Humiston, P. G. Igic, B. K. Jackson, A. K. Jacobson, N. A. Jaffrani, D. Jarzabkowski, M. R. Jazayeri, A. J. Kaplan, R. N. Khant, A. C. Kim, K. A. Klancke, E. J. Kosinski, M. Kovach, J. H. Kramer, E. W. Lader, J. A. LeLevier, N. E. Lepor, R. M. Levy, R. H. Littlefield, R. N. Marple, F. A. McGrew, M. J. McWilliams, A. Meholick, M. J. Mirro, J. F. Murphy, A. V. Murray, V. K. Nadar, M. Nanna, A. J. Navarrete-Casas, D. J. O'Dea, P. G. O'Neill, S. R. Oza, R. J. Patel, N. S. Perlmutter, D. L. Pierce, S. D. Promisloff, J. G. Pulido, J. Rahman, D. V. Rhodes, A. M. Rubin, J. H. Sandberg, C. M. Sandesara, R. Schreiman, A. Shah, K. H. Sheikh, N. Singh, S. B. Sloan, C. W. Sofley, C. S. Staniloae, J. M. Teixeira, W. M. Tuan, B. R. Vaid, R. M. Vicari, N. K. Vijay, K. N. Vora, R. J. Weiss, H. S. Wenocur, A. Yunus

Research output: Contribution to journalArticle

433 Citations (Scopus)

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.)

Original languageEnglish
Pages (from-to)2268-2276
Number of pages9
JournalNew England Journal of Medicine
Volume365
Issue number24
DOIs
Publication statusPublished - Dec 15 2011
Externally publishedYes

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Atrial Fibrillation
Placebos
Confidence Intervals
Cause of Death
Blood Vessels
Hospitalization
Heart Failure
Stroke
Myocardial Infarction
dronedarone
Adrenergic Antagonists
Embolism
Cardiac Arrhythmias
Heart Rate
Blood Pressure
Safety
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Connolly, S. J., Camm, A. J., Halperin, J. L., Joyner, C., Alings, M., Amerena, J., ... Yunus, A. (2011). Dronedarone in high-risk permanent atrial fibrillation. New England Journal of Medicine, 365(24), 2268-2276. https://doi.org/10.1056/NEJMoa1109867

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, Álvaro; Blomström, Per; Borggrefe, Martin; Budaj, Andrzej; Chen, Shih Ann; Ching, Chi Keong; Commerford, Patrick; Dans, Antonio; Davy, Jean Marc; Delacrétaz, Etienne; Di Pasquale, Giuseppe; Diaz, Rafael; Dorian, Paul; Flaker, Greg; Golitsyn, Sergey; Gonzalez-Hermosillo, Antonio; Granger, Christopher B.; Heidbüchel, 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; Tomcsányi, János; 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.; Wyse, D. G.; Cairns, J.; Pfeffer, M.; Pocock, S.; Wellens, H.; Atra, M.; Basart, D. C.; Bornstein, N. M.; Brandes, A.; De Raedt, H.; Doiny, D.; Duray, G. Z.; Dvorakova, H.; Estrada, A.; Fodor, G.; Gross, B.; Halon, D.; Häppölä, O.; Hart, R.; Healey, J. S.; Jacobsson, F.; Kalvach, P.; Krahn, A.; Laine, M.; Maggioni, A. P.; Mairesse, G. H.; Muir, S. W.; Norrving, B.; Peeters, A.; Pizzolato, G.; Ruiz-Ares, G.; Veltmann, C.; Verdecchia, P.; Widimsky, P.; Zaborski, J.; Zimlichman, R.; Demaerschalk, B.; Diener, H. C.; Tirschwell, D.; Holmes, E.; Lawrence, M.; Bajkor, S.; McCready, T.; Meeks, B.; Gao, P.; Smith, J.; Yang, X.; Yuan, F.; Blake, L.; Dunlop, V.; Gasic, Z.; Molnar, S.; Nieuwlaat, R.; Pasadyn, E.; Sephton, J.; Tuhy, R.; Wild, M.; Caccavo, A.; Cartasegna, L. R.; Cuneo, C. A.; Garrido, M. A.; Guzman, L. A.; Hominal, M. A.; Llanos, J. R.; MacKinnon, I. J.; Vico, M. L.; Vogel, D. R.; Zaidman, C. J.; Colquhoun, D.; Counsell, J. T.; de Looze, F. J.; Durbidge, V. K.; Purnell, P. W.; Soward, A. L.; van Gaal, W. J.; William, M.; Burkart-Kuettner, D.; Huber, K.; Pieske, B.; Roithinger, F. X.; Catez, E. M.; Cools, F. J.; De Roy, L.; De Vusser, P.; De Wolf, L.; Deceuninck, O.; Dilling-Boer, D.; Goethals, M. P.; Paparella, G.; Provenier, F.; Scavée, C.; Vervoort, G.; Botelho, R. V.; Braga, J. S.; de Paola, A. A.; de Souza, W. K.; Genta, P. R.; Hernandes, M. E.; Jaber, J.; Lorga-Filho, A. M.; Manenti, E. R.; Jorge, J. C.; Précoma, D. B.; Reis, G.; Rossi, P. R.; Sousa, A. C.; Zimmermann, S. L.; Gronkova, N. I.; Tumbev, H. S.; Bose, S.; Boucher, P.; Cha, J. Y.; Constance, C. M.; Costi, P.; Coutu, B.; Gupta, M.; Kouz, S.; Lam, A. S.; Leather, R.; Pandey, A. S.; Rebane, T.; Savard, D.; St-Hilaire, R.; Vizel, S.; Cobos, J. L.; Corbalan, R.; Donoso, H.; Escobar, E.; Medina, M. E.; Potthoff, S. H.; Raffo, C. A.; Saavedra, J. G.; Tijerino, M. A.; Ballek, L.; Boček, P.; Choura, M.; Dědek, V.; Egert, A.; Hudcovic, M.; Klimsa, Z.; Labrova, R.; Malecha, J.; Petrova, I.; Podpera, I.; Poklopová, Z.; Velimsky, T.; Dixen, U.; Egstrup, K.; Frost, L.; Gislason, G.; Husted, S. E.; Jakobsen, T. J.; Jeppesen, J.; Kaae Dodt, K.; Klarlund, K. K.; Melchior, T. M.; Nielsen, H.; Skagen, K.; Aro, A.; Huikuri, H. V.; Kyto, V.; Nyman, K.; Utriainen, S.; Ylitalo, A.; Fouche, R.; Gacem, K.; Mansour, M.; Pasquie, J. L.; Poulard, J. E.; Appel, K. F.; Axthelm, C.; Bosch, R. F.; Bushoven, P.; Darius, H.; Grönefeld, G. C.; Hanefeld, C.; Haverkamp, W.; Horacek, T.; Israel, C. W.; Killat, H.; Klingenheben, T.; Kreuzer, J.; Leicht, M.; Licka, M. B.; Niethammer, M.; Rieker, W. A.; Salbach, P.; Schenkenberger, I.; Schmidt, A.; Spitzer, S. G.; Toursarkissian, N.; Veltkamp, R.; Weissbrodt, M.; Winkelmann, B. R.; Wurziger, J.; Zemmrich, C.; Vogiatzis, I. A.; Siu, C. W.; Ferencz, G.; Katona, A.; Keltai, K.; Kovács, Z.; Laszlo, Z.; Poor, F.; Szakal, I.; Toldy-Schedel, E.; Vertes, A.; Eldar, M.; Elias, M.; Freedberg, N. A.; Halabi, S.; Hamoud, S.; Katz, A.; Klainman, E. E.; Marmor, A.; Medina, A.; Mosseri, M.; Motro, M.; Stein, G. Y.; Weiss, T.; Zeltser, D.; Calabrese, D.; Cosmi, F.; de Tommasi, F.; Glorioso, N.; Gulizia, M. M.; Mennuni, M.; Piovaccari, G.; Chee, K. H.; Alcocer Gamba, M. A.; Alvarado-Ruiz, R.; Arenas, J. L.; Bayram Llamas, E.; Calvo Vargas, C. G.; Carrillo, J.; Fernandez-Bonetti, P.; Gomez, J. F.; Llamas-Esperón, G.; Lopez Rosas, E.; Matadamas Hernandez, N.; Ramirez Isunza, J. M.; Salcido, E.; Velasco-Sanchez, R. G.; Bartels, G. L.; Bracke, F.; Bruning, T. A.; Cozijnsen, L.; de Weerd, G. J.; den Hartog, F. R.; Geertman, H.; Hamraoui, K.; Heesen, W. F.; Hunze, I.; Idzerda, H. H.; Kragten, J.; Liem, A. H.; Lok, D. J.; Moens, A.; Plomp, J.; Pos, L.; Ramdat Misier, A. R.; Remmen, J. J.; Ruiter, J. H.; Scholten, M. F.; Swart, H. P.; Tans, J. G.; Theunissen, L.; Tukkie, R.; van der Heijden, R.; Van Doorn, D. J.; Van Gelder, I. C.; van Hessen, M. W.; Westendorp, P. H.; Willems, A. R.; Zoet-Nugteren, S. K.; Aitken, S. A.; Elliott, J. M.; Scales, J. E.; Scott, B.; Ternouth, I. F.; Tisch, J.; Berg-Johansen, J.; Husvik, M. A.; Istad, H.; Risberg, K.; Rød, R.; Sirnes, P. A.; Skjelvan, G. K.; Bednarski, J.; Bronisz, M.; Bryniarski, L.; Gniot, J. R.; Kawka-Urbanek, T.; Kopaczewski, J.; Miekus, P.; Pasierski, T. J.; Piepiorka, M.; Prochaczek, F.; Raczak, G.; Rekosz, J.; Stepinska, J.; Szelemej, R.; Szpajer, M.; Zaborska, B.; Cinteza, M. A.; Ciobanu, A. O.; Dan, A. R.; Dimulescu, D.; Fierbinteanu-Braticevici, C. G.; Istratoaie, O.; Lighezan, D. F.; Minescu, B.; Vintila, M. M.; Akhmedzhanov, N. M.; Alikhanov, B. A.; Barabashkina, A. V.; Barbarash, O.; Barbarich, V. B.; Bart, B. Y.; Boyarkin, M. V.; Burova, N. N.; Bychkova, L.; Fitilev, S. B.; Gizatulina, T. P.; Khaisheva, L. A.; Konstantinov, V. O.; Koziolova, N.; Lesnov, V.; Lukyanov, Y.; Lyamina, N. P.; Malkina, T. A.; Miller, O. N.; Moiseev, V.; Novikova, N. V.; Orlikova, O. V.; Orlov, V. A.; Osipenko, M. F.; Panchenko, E.; Platonov, D. Y.; Popov, S. V.; Rafalakiy, V. V.; Ruda, M. Y.; Seliverstova, S. A.; Shalaev, S. V.; Shchekotov, V. V.; Shubik, Y.; Shvarts, Y.; Sulimov, V. A.; Tretyakova, T. V.; Vaniev, S.; Vishnevsky, A.; Yakusevich, V. V.; Yakushin, S. S.; Zrazhevskiy, K. N.; Teo, W. S.; Bugan, V.; Kaliská, G.; Masarovičová, M.; Nociar, J.; Pella, D.; Uhliar, R.; Bushidi, M.; Engelbrecht, J. M.; Okreglicki, A. M.; Pillay, T.; Snyders, F. A.; Theron, H. D.; Venter, T. P.; Cho, J. G.; Kim, D.; Kim, Y. H.; Lee, M. H.; Oh, S.; On, Y. K.; Rho, T. H.; Shin, D. H.; Alzueta, J.; Bruguera, J.; Castrejon, S.; Díaz-Infante, E.; Grigorian Shamagian, L.; Martínez-Rubio, A.; Mont, L.; Vida, M.; Viñolas, X.; Berglund, S. T.; Blomstrom-Lundqvist, C.; Cherfan, P.; Jakobsson, S.; Johansson, L.; Juhlin, T.; Kozak, P.; Rönn, F.; Rosenqvist, M.; Sprock, L.; Gallino, A. F.; Lyrer, P. A.; Moccetti, T.; Chen, M. C.; Hu, Y. F.; Lin, Jiunn-Lee; Wen, M. S.; Karpenko, O. I.; Kozhukhov, S.; Kraiz, I.; Pavlyk, S. S.; Potapenko, P. I.; Prokhorov, O. V.; Prudkyi, I. V.; Prykhodko, V. Y.; Rudenko, L. V.; Sychov, O. S.; Tseluyko, V. I.; Vizir, V. A.; Zharinov, O. J.; Aggarwal, R.; Copley, A. J.; Davey, P. P.; Kadr, H. H.; Lip, G. Y.; Lord, S.; Moriarty, A. J.; Pye, M. P.; Ryding, A. D.; Savelieva, I.; Abadier, R.; Ahmad, S.; Ahmad, Z. M.; Alexander, K. P.; Alfieri, A. D.; Baker, S.; Ball, E. M.; Baruch, L.; Bellam, R. P.; Benjamin, S. A.; Brill, D. A.; Browne, K. F.; Call, J. T.; Carr, K. W.; Chandna, H.; Chen, C.; Chen, Y. C.; Chilakapati, V. S.; Colan, D.; Cossu, S. F.; Dean, J.; DeFehr, S. P.; Dempsey, S. J.; Desai, V. S.; Dohrmann, M. L.; Ellison, H. S.; Emlein, G.; Farris, N.; Fields, R. H.; Fishbein, G. J.; Flores, E. A.; Friedlander, I. R.; Gelernt, M. D.; Genovely, H. C.; Gillespie, E. L.; Go, B. M.; Gottlieb, D. W.; Grena, P. G.; Guarnieri, T.; Gupta, D. K.; Haidar, A. A.; Hamroff, G. S.; Hargrove, J. L.; Haskel, E. J.; Hearne, S. E.; Henderson, D. A.; Herre, J. M.; Herzog, W. R.; Hoppe, B. L.; Hotchkiss, D.; Humiston, D. J.; Igic, P. G.; Jackson, B. K.; Jacobson, A. K.; Jaffrani, N. A.; Jarzabkowski, D.; Jazayeri, M. R.; Kaplan, A. J.; Khant, R. N.; Kim, A. C.; Klancke, K. A.; Kosinski, E. J.; Kovach, M.; Kramer, J. H.; Lader, E. W.; LeLevier, J. A.; Lepor, N. E.; Levy, R. M.; Littlefield, R. H.; Marple, R. N.; McGrew, F. A.; McWilliams, M. J.; Meholick, A.; Mirro, M. J.; Murphy, J. F.; Murray, A. V.; Nadar, V. K.; Nanna, M.; Navarrete-Casas, A. J.; O'Dea, D. J.; O'Neill, P. G.; Oza, S. R.; Patel, R. J.; Perlmutter, N. S.; Pierce, D. L.; Promisloff, S. D.; Pulido, J. G.; Rahman, J.; Rhodes, D. V.; Rubin, A. M.; Sandberg, J. H.; Sandesara, C. M.; Schreiman, R.; Shah, A.; Sheikh, K. H.; Singh, N.; Sloan, S. B.; Sofley, C. W.; Staniloae, C. S.; Teixeira, J. M.; Tuan, W. M.; Vaid, B. R.; Vicari, R. M.; Vijay, N. K.; Vora, K. N.; Weiss, R. J.; Wenocur, H. S.; Yunus, A.

In: New England Journal of Medicine, Vol. 365, No. 24, 15.12.2011, p. 2268-2276.

Research output: Contribution to journalArticle

Connolly, SJ, Camm, AJ, Halperin, JL, Joyner, C, Alings, M, Amerena, J, Atar, D, Avezum, Á, Blomström, P, Borggrefe, M, Budaj, A, Chen, SA, Ching, CK, Commerford, P, Dans, A, Davy, JM, Delacrétaz, E, Di Pasquale, G, Diaz, R, Dorian, P, Flaker, G, Golitsyn, S, Gonzalez-Hermosillo, A, Granger, CB, Heidbüchel, H, Kautzner, J, Kim, JS, Lanas, F, Lewis, BS, Merino, JL, Morillo, C, Murin, J, Narasimhan, C, Paolasso, E, Parkhomenko, A, Peters, NS, Sim, KH, Stiles, MK, Tanomsup, S, Toivonen, L, Tomcsányi, J, Torp-Pedersen, C, Tse, HF, Vardas, P, Vinereanu, D, Xavier, D, Zhu, J, Zhu, JR, Baret-Cormel, L, Weinling, E, Staiger, C, Yusuf, S, Chrolavicius, S, Afzal, R, Hohnloser, SH, Wyse, DG, Cairns, J, Pfeffer, M, Pocock, S, Wellens, H, Atra, M, Basart, DC, Bornstein, NM, Brandes, A, De Raedt, H, Doiny, D, Duray, GZ, Dvorakova, H, Estrada, A, Fodor, G, Gross, B, Halon, D, Häppölä, O, Hart, R, Healey, JS, Jacobsson, F, Kalvach, P, Krahn, A, Laine, M, Maggioni, AP, Mairesse, GH, Muir, SW, Norrving, B, Peeters, A, Pizzolato, G, Ruiz-Ares, G, Veltmann, C, Verdecchia, P, Widimsky, P, Zaborski, J, Zimlichman, R, Demaerschalk, B, Diener, HC, Tirschwell, D, Holmes, E, Lawrence, M, Bajkor, S, McCready, T, Meeks, B, Gao, P, Smith, J, Yang, X, Yuan, F, Blake, L, Dunlop, V, Gasic, Z, Molnar, S, Nieuwlaat, R, Pasadyn, E, Sephton, J, Tuhy, R, Wild, M, Caccavo, A, Cartasegna, LR, Cuneo, CA, Garrido, MA, Guzman, LA, Hominal, MA, Llanos, JR, MacKinnon, IJ, Vico, ML, Vogel, DR, Zaidman, CJ, Colquhoun, D, Counsell, JT, de Looze, FJ, Durbidge, VK, Purnell, PW, Soward, AL, van Gaal, WJ, William, M, Burkart-Kuettner, D, Huber, K, Pieske, B, Roithinger, FX, Catez, EM, Cools, FJ, De Roy, L, De Vusser, P, De Wolf, L, Deceuninck, O, Dilling-Boer, D, Goethals, MP, Paparella, G, Provenier, F, Scavée, C, Vervoort, G, Botelho, RV, Braga, JS, de Paola, AA, de Souza, WK, Genta, PR, Hernandes, ME, Jaber, J, Lorga-Filho, AM, Manenti, ER, Jorge, JC, Précoma, DB, Reis, G, Rossi, PR, Sousa, AC, Zimmermann, SL, Gronkova, NI, Tumbev, HS, Bose, S, Boucher, P, Cha, JY, Constance, CM, Costi, P, Coutu, B, Gupta, M, Kouz, S, Lam, AS, Leather, R, Pandey, AS, Rebane, T, Savard, D, St-Hilaire, R, Vizel, S, Cobos, JL, Corbalan, R, Donoso, H, Escobar, E, Medina, ME, Potthoff, SH, Raffo, CA, Saavedra, JG, Tijerino, MA, Ballek, L, Boček, P, Choura, M, Dědek, V, Egert, A, Hudcovic, M, Klimsa, Z, Labrova, R, Malecha, J, Petrova, I, Podpera, I, Poklopová, Z, Velimsky, T, Dixen, U, Egstrup, K, Frost, L, Gislason, G, Husted, SE, Jakobsen, TJ, Jeppesen, J, Kaae Dodt, K, Klarlund, KK, Melchior, TM, Nielsen, H, Skagen, K, Aro, A, Huikuri, HV, Kyto, V, Nyman, K, Utriainen, S, Ylitalo, A, Fouche, R, Gacem, K, Mansour, M, Pasquie, JL, Poulard, JE, Appel, KF, Axthelm, C, Bosch, RF, Bushoven, P, Darius, H, Grönefeld, GC, Hanefeld, C, Haverkamp, W, Horacek, T, Israel, CW, Killat, H, Klingenheben, T, Kreuzer, J, Leicht, M, Licka, MB, Niethammer, M, Rieker, WA, Salbach, P, Schenkenberger, I, Schmidt, A, Spitzer, SG, Toursarkissian, N, Veltkamp, R, Weissbrodt, M, Winkelmann, BR, Wurziger, J, Zemmrich, C, Vogiatzis, IA, Siu, CW, Ferencz, G, Katona, A, Keltai, K, Kovács, Z, Laszlo, Z, Poor, F, Szakal, I, Toldy-Schedel, E, Vertes, A, Eldar, M, Elias, M, Freedberg, NA, Halabi, S, Hamoud, S, Katz, A, Klainman, EE, Marmor, A, Medina, A, Mosseri, M, Motro, M, Stein, GY, Weiss, T, Zeltser, D, Calabrese, D, Cosmi, F, de Tommasi, F, Glorioso, N, Gulizia, MM, Mennuni, M, Piovaccari, G, Chee, KH, Alcocer Gamba, MA, Alvarado-Ruiz, R, Arenas, JL, Bayram Llamas, E, Calvo Vargas, CG, Carrillo, J, Fernandez-Bonetti, P, Gomez, JF, Llamas-Esperón, G, Lopez Rosas, E, Matadamas Hernandez, N, Ramirez Isunza, JM, Salcido, E, Velasco-Sanchez, RG, Bartels, GL, Bracke, F, Bruning, TA, Cozijnsen, L, de Weerd, GJ, den Hartog, FR, Geertman, H, Hamraoui, K, Heesen, WF, Hunze, I, Idzerda, HH, Kragten, J, Liem, AH, Lok, DJ, Moens, A, Plomp, J, Pos, L, Ramdat Misier, AR, Remmen, JJ, Ruiter, JH, Scholten, MF, Swart, HP, Tans, JG, Theunissen, L, Tukkie, R, van der Heijden, R, Van Doorn, DJ, Van Gelder, IC, van Hessen, MW, Westendorp, PH, Willems, AR, Zoet-Nugteren, SK, Aitken, SA, Elliott, JM, Scales, JE, Scott, B, Ternouth, IF, Tisch, J, Berg-Johansen, J, Husvik, MA, Istad, H, Risberg, K, Rød, R, Sirnes, PA, Skjelvan, GK, Bednarski, J, Bronisz, M, Bryniarski, L, Gniot, JR, Kawka-Urbanek, T, Kopaczewski, J, Miekus, P, Pasierski, TJ, Piepiorka, M, Prochaczek, F, Raczak, G, Rekosz, J, Stepinska, J, Szelemej, R, Szpajer, M, Zaborska, B, Cinteza, MA, Ciobanu, AO, Dan, AR, Dimulescu, D, Fierbinteanu-Braticevici, CG, Istratoaie, O, Lighezan, DF, Minescu, B, Vintila, MM, Akhmedzhanov, NM, Alikhanov, BA, Barabashkina, AV, Barbarash, O, Barbarich, VB, Bart, BY, Boyarkin, MV, Burova, NN, Bychkova, L, Fitilev, SB, Gizatulina, TP, Khaisheva, LA, Konstantinov, VO, Koziolova, N, Lesnov, V, Lukyanov, Y, Lyamina, NP, Malkina, TA, Miller, ON, Moiseev, V, Novikova, NV, Orlikova, OV, Orlov, VA, Osipenko, MF, Panchenko, E, Platonov, DY, Popov, SV, Rafalakiy, VV, Ruda, MY, Seliverstova, SA, Shalaev, SV, Shchekotov, VV, Shubik, Y, Shvarts, Y, Sulimov, VA, Tretyakova, TV, Vaniev, S, Vishnevsky, A, Yakusevich, VV, Yakushin, SS, Zrazhevskiy, KN, Teo, WS, Bugan, V, Kaliská, G, Masarovičová, M, Nociar, J, Pella, D, Uhliar, R, Bushidi, M, Engelbrecht, JM, Okreglicki, AM, Pillay, T, Snyders, FA, Theron, HD, Venter, TP, Cho, JG, Kim, D, Kim, YH, Lee, MH, Oh, S, On, YK, Rho, TH, Shin, DH, Alzueta, J, Bruguera, J, Castrejon, S, Díaz-Infante, E, Grigorian Shamagian, L, Martínez-Rubio, A, Mont, L, Vida, M, Viñolas, X, Berglund, ST, Blomstrom-Lundqvist, C, Cherfan, P, Jakobsson, S, Johansson, L, Juhlin, T, Kozak, P, Rönn, F, Rosenqvist, M, Sprock, L, Gallino, AF, Lyrer, PA, Moccetti, T, Chen, MC, Hu, YF, Lin, J-L, Wen, MS, Karpenko, OI, Kozhukhov, S, Kraiz, I, Pavlyk, SS, Potapenko, PI, Prokhorov, OV, Prudkyi, IV, Prykhodko, VY, Rudenko, LV, Sychov, OS, Tseluyko, VI, Vizir, VA, Zharinov, OJ, Aggarwal, R, Copley, AJ, Davey, PP, Kadr, HH, Lip, GY, Lord, S, Moriarty, AJ, Pye, MP, Ryding, AD, Savelieva, I, Abadier, R, Ahmad, S, Ahmad, ZM, Alexander, KP, Alfieri, AD, Baker, S, Ball, EM, Baruch, L, Bellam, RP, Benjamin, SA, Brill, DA, Browne, KF, Call, JT, Carr, KW, Chandna, H, Chen, C, Chen, YC, Chilakapati, VS, Colan, D, Cossu, SF, Dean, J, DeFehr, SP, Dempsey, SJ, Desai, VS, Dohrmann, ML, Ellison, HS, Emlein, G, Farris, N, Fields, RH, Fishbein, GJ, Flores, EA, Friedlander, IR, Gelernt, MD, Genovely, HC, Gillespie, EL, Go, BM, Gottlieb, DW, Grena, PG, Guarnieri, T, Gupta, DK, Haidar, AA, Hamroff, GS, Hargrove, JL, Haskel, EJ, Hearne, SE, Henderson, DA, Herre, JM, Herzog, WR, Hoppe, BL, Hotchkiss, D, Humiston, DJ, Igic, PG, Jackson, BK, Jacobson, AK, Jaffrani, NA, Jarzabkowski, D, Jazayeri, MR, Kaplan, AJ, Khant, RN, Kim, AC, Klancke, KA, Kosinski, EJ, Kovach, M, Kramer, JH, Lader, EW, LeLevier, JA, Lepor, NE, Levy, RM, Littlefield, RH, Marple, RN, McGrew, FA, McWilliams, MJ, Meholick, A, Mirro, MJ, Murphy, JF, Murray, AV, Nadar, VK, Nanna, M, Navarrete-Casas, AJ, O'Dea, DJ, O'Neill, PG, Oza, SR, Patel, RJ, Perlmutter, NS, Pierce, DL, Promisloff, SD, Pulido, JG, Rahman, J, Rhodes, DV, Rubin, AM, Sandberg, JH, Sandesara, CM, Schreiman, R, Shah, A, Sheikh, KH, Singh, N, Sloan, SB, Sofley, CW, Staniloae, CS, Teixeira, JM, Tuan, WM, Vaid, BR, Vicari, RM, Vijay, NK, Vora, KN, Weiss, RJ, Wenocur, HS & Yunus, A 2011, 'Dronedarone in high-risk permanent atrial fibrillation', New England Journal of Medicine, vol. 365, no. 24, pp. 2268-2276. https://doi.org/10.1056/NEJMoa1109867
Connolly SJ, Camm AJ, Halperin JL, Joyner C, Alings M, Amerena J et al. Dronedarone in high-risk permanent atrial fibrillation. New England Journal of Medicine. 2011 Dec 15;365(24):2268-2276. https://doi.org/10.1056/NEJMoa1109867
Connolly, Stuart J. ; Camm, A. John ; Halperin, Jonathan L. ; Joyner, Campbell ; Alings, Marco ; Amerena, John ; Atar, Dan ; Avezum, Álvaro ; Blomström, Per ; Borggrefe, Martin ; Budaj, Andrzej ; Chen, Shih Ann ; Ching, Chi Keong ; Commerford, Patrick ; Dans, Antonio ; Davy, Jean Marc ; Delacrétaz, Etienne ; Di Pasquale, Giuseppe ; Diaz, Rafael ; Dorian, Paul ; Flaker, Greg ; Golitsyn, Sergey ; Gonzalez-Hermosillo, Antonio ; Granger, Christopher B. ; Heidbüchel, 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 ; Tomcsányi, János ; 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. ; Wyse, D. G. ; Cairns, J. ; Pfeffer, M. ; Pocock, S. ; Wellens, H. ; Atra, M. ; Basart, D. C. ; Bornstein, N. M. ; Brandes, A. ; De Raedt, H. ; Doiny, D. ; Duray, G. Z. ; Dvorakova, H. ; Estrada, A. ; Fodor, G. ; Gross, B. ; Halon, D. ; Häppölä, O. ; Hart, R. ; Healey, J. S. ; Jacobsson, F. ; Kalvach, P. ; Krahn, A. ; Laine, M. ; Maggioni, A. P. ; Mairesse, G. H. ; Muir, S. W. ; Norrving, B. ; Peeters, A. ; Pizzolato, G. ; Ruiz-Ares, G. ; Veltmann, C. ; Verdecchia, P. ; Widimsky, P. ; Zaborski, J. ; Zimlichman, R. ; Demaerschalk, B. ; Diener, H. C. ; Tirschwell, D. ; Holmes, E. ; Lawrence, M. ; Bajkor, S. ; McCready, T. ; Meeks, B. ; Gao, P. ; Smith, J. ; Yang, X. ; Yuan, F. ; Blake, L. ; Dunlop, V. ; Gasic, Z. ; Molnar, S. ; Nieuwlaat, R. ; Pasadyn, E. ; Sephton, J. ; Tuhy, R. ; Wild, M. ; Caccavo, A. ; Cartasegna, L. R. ; Cuneo, C. A. ; Garrido, M. A. ; Guzman, L. A. ; Hominal, M. A. ; Llanos, J. R. ; MacKinnon, I. J. ; Vico, M. L. ; Vogel, D. R. ; Zaidman, C. J. ; Colquhoun, D. ; Counsell, J. T. ; de Looze, F. J. ; Durbidge, V. K. ; Purnell, P. W. ; Soward, A. L. ; van Gaal, W. J. ; William, M. ; Burkart-Kuettner, D. ; Huber, K. ; Pieske, B. ; Roithinger, F. X. ; Catez, E. M. ; Cools, F. J. ; De Roy, L. ; De Vusser, P. ; De Wolf, L. ; Deceuninck, O. ; Dilling-Boer, D. ; Goethals, M. P. ; Paparella, G. ; Provenier, F. ; Scavée, C. ; Vervoort, G. ; Botelho, R. V. ; Braga, J. S. ; de Paola, A. A. ; de Souza, W. K. ; Genta, P. R. ; Hernandes, M. E. ; Jaber, J. ; Lorga-Filho, A. M. ; Manenti, E. R. ; Jorge, J. C. ; Précoma, D. B. ; Reis, G. ; Rossi, P. R. ; Sousa, A. C. ; Zimmermann, S. L. ; Gronkova, N. I. ; Tumbev, H. S. ; Bose, S. ; Boucher, P. ; Cha, J. Y. ; Constance, C. M. ; Costi, P. ; Coutu, B. ; Gupta, M. ; Kouz, S. ; Lam, A. S. ; Leather, R. ; Pandey, A. S. ; Rebane, T. ; Savard, D. ; St-Hilaire, R. ; Vizel, S. ; Cobos, J. L. ; Corbalan, R. ; Donoso, H. ; Escobar, E. ; Medina, M. E. ; Potthoff, S. H. ; Raffo, C. A. ; Saavedra, J. G. ; Tijerino, M. A. ; Ballek, L. ; Boček, P. ; Choura, M. ; Dědek, V. ; Egert, A. ; Hudcovic, M. ; Klimsa, Z. ; Labrova, R. ; Malecha, J. ; Petrova, I. ; Podpera, I. ; Poklopová, Z. ; Velimsky, T. ; Dixen, U. ; Egstrup, K. ; Frost, L. ; Gislason, G. ; Husted, S. E. ; Jakobsen, T. J. ; Jeppesen, J. ; Kaae Dodt, K. ; Klarlund, K. K. ; Melchior, T. M. ; Nielsen, H. ; Skagen, K. ; Aro, A. ; Huikuri, H. V. ; Kyto, V. ; Nyman, K. ; Utriainen, S. ; Ylitalo, A. ; Fouche, R. ; Gacem, K. ; Mansour, M. ; Pasquie, J. L. ; Poulard, J. E. ; Appel, K. F. ; Axthelm, C. ; Bosch, R. F. ; Bushoven, P. ; Darius, H. ; Grönefeld, G. C. ; Hanefeld, C. ; Haverkamp, W. ; Horacek, T. ; Israel, C. W. ; Killat, H. ; Klingenheben, T. ; Kreuzer, J. ; Leicht, M. ; Licka, M. B. ; Niethammer, M. ; Rieker, W. A. ; Salbach, P. ; Schenkenberger, I. ; Schmidt, A. ; Spitzer, S. G. ; Toursarkissian, N. ; Veltkamp, R. ; Weissbrodt, M. ; Winkelmann, B. R. ; Wurziger, J. ; Zemmrich, C. ; Vogiatzis, I. A. ; Siu, C. W. ; Ferencz, G. ; Katona, A. ; Keltai, K. ; Kovács, Z. ; Laszlo, Z. ; Poor, F. ; Szakal, I. ; Toldy-Schedel, E. ; Vertes, A. ; Eldar, M. ; Elias, M. ; Freedberg, N. A. ; Halabi, S. ; Hamoud, S. ; Katz, A. ; Klainman, E. E. ; Marmor, A. ; Medina, A. ; Mosseri, M. ; Motro, M. ; Stein, G. Y. ; Weiss, T. ; Zeltser, D. ; Calabrese, D. ; Cosmi, F. ; de Tommasi, F. ; Glorioso, N. ; Gulizia, M. M. ; Mennuni, M. ; Piovaccari, G. ; Chee, K. H. ; Alcocer Gamba, M. A. ; Alvarado-Ruiz, R. ; Arenas, J. L. ; Bayram Llamas, E. ; Calvo Vargas, C. G. ; Carrillo, J. ; Fernandez-Bonetti, P. ; Gomez, J. F. ; Llamas-Esperón, G. ; Lopez Rosas, E. ; Matadamas Hernandez, N. ; Ramirez Isunza, J. M. ; Salcido, E. ; Velasco-Sanchez, R. G. ; Bartels, G. L. ; Bracke, F. ; Bruning, T. A. ; Cozijnsen, L. ; de Weerd, G. J. ; den Hartog, F. R. ; Geertman, H. ; Hamraoui, K. ; Heesen, W. F. ; Hunze, I. ; Idzerda, H. H. ; Kragten, J. ; Liem, A. H. ; Lok, D. J. ; Moens, A. ; Plomp, J. ; Pos, L. ; Ramdat Misier, A. 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V. ; Nadar, V. K. ; Nanna, M. ; Navarrete-Casas, A. J. ; O'Dea, D. J. ; O'Neill, P. G. ; Oza, S. R. ; Patel, R. J. ; Perlmutter, N. S. ; Pierce, D. L. ; Promisloff, S. D. ; Pulido, J. G. ; Rahman, J. ; Rhodes, D. V. ; Rubin, A. M. ; Sandberg, J. H. ; Sandesara, C. M. ; Schreiman, R. ; Shah, A. ; Sheikh, K. H. ; Singh, N. ; Sloan, S. B. ; Sofley, C. W. ; Staniloae, C. S. ; Teixeira, J. M. ; Tuan, W. M. ; Vaid, B. R. ; Vicari, R. M. ; Vijay, N. K. ; Vora, K. N. ; Weiss, R. J. ; Wenocur, H. S. ; Yunus, A. / Dronedarone in high-risk permanent atrial fibrillation. In: New England Journal of Medicine. 2011 ; Vol. 365, No. 24. pp. 2268-2276.
@article{a736d9ec188c41de8c550daceb4f89b6,
title = "Dronedarone in high-risk permanent atrial fibrillation",
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.)",
author = "Connolly, {Stuart J.} and Camm, {A. 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G.} and J. Cairns and M. Pfeffer and S. Pocock and H. Wellens and M. Atra and Basart, {D. C.} and Bornstein, {N. M.} and A. Brandes and {De Raedt}, H. and D. Doiny and Duray, {G. Z.} and H. Dvorakova and A. Estrada and G. Fodor and B. Gross and D. Halon and O. H{\"a}pp{\"o}l{\"a} and R. Hart and Healey, {J. S.} and F. Jacobsson and P. Kalvach and A. Krahn and M. Laine and Maggioni, {A. P.} and Mairesse, {G. H.} and Muir, {S. W.} and B. Norrving and A. Peeters and G. Pizzolato and G. Ruiz-Ares and C. Veltmann and P. Verdecchia and P. Widimsky and J. Zaborski and R. Zimlichman and B. Demaerschalk and Diener, {H. C.} and D. Tirschwell and E. Holmes and M. Lawrence and S. Bajkor and T. McCready and B. Meeks and P. Gao and J. Smith and X. Yang and F. Yuan and L. Blake and V. Dunlop and Z. Gasic and S. Molnar and R. Nieuwlaat and E. Pasadyn and J. Sephton and R. Tuhy and M. Wild and A. Caccavo and Cartasegna, {L. R.} and Cuneo, {C. A.} and Garrido, {M. A.} and Guzman, {L. 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Vida and X. Vi{\~n}olas and Berglund, {S. T.} and C. Blomstrom-Lundqvist and P. Cherfan and S. Jakobsson and L. Johansson and T. Juhlin and P. Kozak and F. R{\"o}nn and M. Rosenqvist and L. Sprock and Gallino, {A. F.} and Lyrer, {P. A.} and T. Moccetti and Chen, {M. C.} and Hu, {Y. F.} and Jiunn-Lee Lin and Wen, {M. S.} and Karpenko, {O. I.} and S. Kozhukhov and I. Kraiz and Pavlyk, {S. S.} and Potapenko, {P. I.} and Prokhorov, {O. V.} and Prudkyi, {I. V.} and Prykhodko, {V. Y.} and Rudenko, {L. V.} and Sychov, {O. S.} and Tseluyko, {V. I.} and Vizir, {V. A.} and Zharinov, {O. J.} and R. Aggarwal and Copley, {A. J.} and Davey, {P. P.} and Kadr, {H. H.} and Lip, {G. Y.} and S. Lord and Moriarty, {A. J.} and Pye, {M. P.} and Ryding, {A. D.} and I. Savelieva and R. Abadier and S. Ahmad and Ahmad, {Z. M.} and Alexander, {K. P.} and Alfieri, {A. D.} and S. Baker and Ball, {E. M.} and L. Baruch and Bellam, {R. P.} and Benjamin, {S. A.} and Brill, {D. A.} and Browne, {K. F.} and Call, {J. T.} and Carr, {K. W.} and H. Chandna and C. Chen and Chen, {Y. C.} and Chilakapati, {V. S.} and D. Colan and Cossu, {S. F.} and J. Dean and DeFehr, {S. P.} and Dempsey, {S. J.} and Desai, {V. S.} and Dohrmann, {M. L.} and Ellison, {H. S.} and G. Emlein and N. Farris and Fields, {R. H.} and Fishbein, {G. J.} and Flores, {E. A.} and Friedlander, {I. R.} and Gelernt, {M. D.} and Genovely, {H. C.} and Gillespie, {E. L.} and Go, {B. M.} and Gottlieb, {D. W.} and Grena, {P. G.} and T. Guarnieri and Gupta, {D. K.} and Haidar, {A. A.} and Hamroff, {G. S.} and Hargrove, {J. L.} and Haskel, {E. J.} and Hearne, {S. E.} and Henderson, {D. A.} and Herre, {J. M.} and Herzog, {W. R.} and Hoppe, {B. L.} and D. Hotchkiss and Humiston, {D. J.} and Igic, {P. G.} and Jackson, {B. K.} and Jacobson, {A. K.} and Jaffrani, {N. A.} and D. Jarzabkowski and Jazayeri, {M. R.} and Kaplan, {A. J.} and Khant, {R. N.} and Kim, {A. C.} and Klancke, {K. A.} and Kosinski, {E. J.} and M. Kovach and Kramer, {J. H.} and Lader, {E. W.} and LeLevier, {J. A.} and Lepor, {N. E.} and Levy, {R. M.} and Littlefield, {R. H.} and Marple, {R. N.} and McGrew, {F. A.} and McWilliams, {M. J.} and A. Meholick and Mirro, {M. J.} and Murphy, {J. F.} and Murray, {A. V.} and Nadar, {V. K.} and M. Nanna and Navarrete-Casas, {A. J.} and O'Dea, {D. J.} and O'Neill, {P. G.} and Oza, {S. R.} and Patel, {R. J.} and Perlmutter, {N. S.} and Pierce, {D. L.} and Promisloff, {S. D.} and Pulido, {J. G.} and J. Rahman and Rhodes, {D. V.} and Rubin, {A. M.} and Sandberg, {J. H.} and Sandesara, {C. M.} and R. Schreiman and A. Shah and Sheikh, {K. H.} and N. Singh and Sloan, {S. B.} and Sofley, {C. W.} and Staniloae, {C. S.} and Teixeira, {J. M.} and Tuan, {W. M.} and Vaid, {B. R.} and Vicari, {R. M.} and Vijay, {N. K.} and Vora, {K. N.} and Weiss, {R. J.} and Wenocur, {H. S.} and A. Yunus",
year = "2011",
month = "12",
day = "15",
doi = "10.1056/NEJMoa1109867",
language = "English",
volume = "365",
pages = "2268--2276",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "24",

}

TY - JOUR

T1 - Dronedarone in high-risk permanent atrial fibrillation

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AU - Flores, E. A.

AU - Friedlander, I. R.

AU - Gelernt, M. D.

AU - Genovely, H. C.

AU - Gillespie, E. L.

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AU - Haidar, A. A.

AU - Hamroff, G. S.

AU - Hargrove, J. L.

AU - Haskel, E. J.

AU - Hearne, S. E.

AU - Henderson, D. A.

AU - Herre, J. M.

AU - Herzog, W. R.

AU - Hoppe, B. L.

AU - Hotchkiss, D.

AU - Humiston, D. J.

AU - Igic, P. G.

AU - Jackson, B. K.

AU - Jacobson, A. K.

AU - Jaffrani, N. A.

AU - Jarzabkowski, D.

AU - Jazayeri, M. R.

AU - Kaplan, A. J.

AU - Khant, R. N.

AU - Kim, A. C.

AU - Klancke, K. A.

AU - Kosinski, E. J.

AU - Kovach, M.

AU - Kramer, J. H.

AU - Lader, E. W.

AU - LeLevier, J. A.

AU - Lepor, N. E.

AU - Levy, R. M.

AU - Littlefield, R. H.

AU - Marple, R. N.

AU - McGrew, F. A.

AU - McWilliams, M. J.

AU - Meholick, A.

AU - Mirro, M. J.

AU - Murphy, J. F.

AU - Murray, A. V.

AU - Nadar, V. K.

AU - Nanna, M.

AU - Navarrete-Casas, A. J.

AU - O'Dea, D. J.

AU - O'Neill, P. G.

AU - Oza, S. R.

AU - Patel, R. J.

AU - Perlmutter, N. S.

AU - Pierce, D. L.

AU - Promisloff, S. D.

AU - Pulido, J. G.

AU - Rahman, J.

AU - Rhodes, D. V.

AU - Rubin, A. M.

AU - Sandberg, J. H.

AU - Sandesara, C. M.

AU - Schreiman, R.

AU - Shah, A.

AU - Sheikh, K. H.

AU - Singh, N.

AU - Sloan, S. B.

AU - Sofley, C. W.

AU - Staniloae, C. S.

AU - Teixeira, J. M.

AU - Tuan, W. M.

AU - Vaid, B. R.

AU - Vicari, R. M.

AU - Vijay, N. K.

AU - Vora, K. N.

AU - Weiss, R. J.

AU - Wenocur, H. S.

AU - Yunus, A.

PY - 2011/12/15

Y1 - 2011/12/15

N2 - 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.)

AB - 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.)

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U2 - 10.1056/NEJMoa1109867

DO - 10.1056/NEJMoa1109867

M3 - Article

C2 - 22082198

AN - SCOPUS:84855163167

VL - 365

SP - 2268

EP - 2276

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 24

ER -