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N Engl J Med. 2011 Dec 15;365(24):2268-76. doi: 10.1056/NEJMoa1109867. Epub 2011 Nov 14.

Dronedarone in high-risk permanent atrial fibrillation.

Collaborators (550)

Wyse DG, Cairns J, Pfeffer M, Pocock S, Wellens H, Atra M, Avezum A, 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, Joyner C, Kalvach P, Krahn A, Laine M, Maggioni AP, Mairesse GH, Muir SW, Norrving B, Peeters A, Pizzolato G, Ruiz-Ares G, Torp-Pedersen C, Veltmann C, Verdecchia P, Widimsky P, Zaborski J, Zimlichman R, Demaerschalk B, Diener HC, Hart R, Tirschwell D, Chrolavicius S, Holmes E, Lawrence M, Bajkor S, McCready T, Meeks B, Afzal R, 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, Mairesse GH, 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 Jr, Cha JY, Constance CM, Costi P, Coutu B, Gupta M, Healey JS, 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, Brandes A, 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, Veltmann C, Weissbrodt M, Winkelmann BR, Wurziger J, Zemmrich C, Vogiatzis IA, Siu CW, Duray GZ, Ferencz G, Katona A, Keltai K, Kovács Z, Laszlo Z, Poor F, Szakal I, Toldy-Schedel E, Vertes A, Atar S, 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, Zimlichman R, Calabrese D, Cosmi F, de Tommasi F, Glorioso N, Gulizia MM, Mennuni M, Piovaccari G, Verdecchia P, 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, Basart DC, 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, Jacobsson F, 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 JL, 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, Muir SW, 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 Jr, 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 Jr, 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 3rd, 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 Jr, Staniloae CS, Teixeira JM, Tuan WM, Vaid BR, Vicari RM, Vijay NK, Vora KN, Weiss RJ, Wenocur HS, Yunus A.

Author information

  • 1Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON L8L 2X2, Canada. connostu@phri.ca

Erratum in

  • N Engl J Med. 2012 Feb 16;366(7):672.

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.).

Comment in

PMID:
22082198
[PubMed - indexed for MEDLINE]
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