Article: Dronedarone in high-risk permanent atrial fibrillation

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TitleDronedarone in high-risk permanent atrial fibrillation
AuthorsConnolly, SJ22
Camm, AJ34
Halperin, JL10
Joyner, C38
Alings, M30
Amerena, J1
Atar, D36
Avezum, Á39
Blomström, P33
Borggrefe, M18
Budaj, A40
Chen, SA9
Ching, CK16
Commerford, P47
Dans, A21
Davy, JM15
Delacrétaz, E28
Di Pasquale, G14
Diaz, R26
Dorian, P19
Flaker, G46
Golitsyn, S8
GonzalezHermosillo, A43
Granger, CB5
Heidbüchel, H23
Kautzner, J12
Kim, JS31
Lanas, F17
Lewis, BS7
Merino, JL2
Morillo, C22
Murin, J42
Narasimhan, C3
Paolasso, E4
Parkhomenko, A44
Peters, NS29
Sim, KH41
Stiles, MK25
Tanomsup, S13
Toivonen, L48
Tomcsányi, J37
TorpPedersen, C6
Tse, HF35
Vardas, P24
Vinereanu, D32
Xavier, D11
Zhu, J
Zhu, JR20
BaretCormel, L45
Weinling, E45
Staiger, C45
Yusuf, S22
Chrolavicius, S22
Afzal, R22
Hohnloser, SH27
Issue Date2011
PublisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/
CitationNew England Journal Of Medicine, 2011, v. 365 n. 24, p. 2268-2276 [How to Cite?]
DOI: http://dx.doi.org/10.1056/NEJMoa1109867
AbstractBACKGROUND: 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.
ISSN0028-4793
2011 Impact Factor: 53.298
2011 SCImago Journal Rankings: 3.412
DOIhttp://dx.doi.org/10.1056/NEJMoa1109867
ReferencesReferences in Scopus
DC Field
Value
dc.contributor.authorConnolly, SJ
dc.contributor.authorCamm, AJ
dc.contributor.authorHalperin, JL
dc.contributor.authorJoyner, C
dc.contributor.authorAlings, M
dc.contributor.authorAmerena, J
dc.contributor.authorAtar, D
dc.contributor.authorAvezum, Á
dc.contributor.authorBlomström, P
dc.contributor.authorBorggrefe, M
dc.contributor.authorBudaj, A
dc.contributor.authorChen, SA
dc.contributor.authorChing, CK
dc.contributor.authorCommerford, P
dc.contributor.authorDans, A
dc.contributor.authorDavy, JM
dc.contributor.authorDelacrétaz, E
dc.contributor.authorDi Pasquale, G
dc.contributor.authorDiaz, R
dc.contributor.authorDorian, P
dc.contributor.authorFlaker, G
dc.contributor.authorGolitsyn, S
dc.contributor.authorGonzalezHermosillo, A
dc.contributor.authorGranger, CB
dc.contributor.authorHeidbüchel, H
dc.contributor.authorKautzner, J
dc.contributor.authorKim, JS
dc.contributor.authorLanas, F
dc.contributor.authorLewis, BS
dc.contributor.authorMerino, JL
dc.contributor.authorMorillo, C
dc.contributor.authorMurin, J
dc.contributor.authorNarasimhan, C
dc.contributor.authorPaolasso, E
dc.contributor.authorParkhomenko, A
dc.contributor.authorPeters, NS
dc.contributor.authorSim, KH
dc.contributor.authorStiles, MK
dc.contributor.authorTanomsup, S
dc.contributor.authorToivonen, L
dc.contributor.authorTomcsányi, J
dc.contributor.authorTorpPedersen, C
dc.contributor.authorTse, HF
dc.contributor.authorVardas, P
dc.contributor.authorVinereanu, D
dc.contributor.authorXavier, D
dc.contributor.authorZhu, J
dc.contributor.authorZhu, JR
dc.contributor.authorBaretCormel, L
dc.contributor.authorWeinling, E
dc.contributor.authorStaiger, C
dc.contributor.authorYusuf, S
dc.contributor.authorChrolavicius, S
dc.contributor.authorAfzal, R
dc.contributor.authorHohnloser, SH
dc.date.accessioned2012-07-16T09:47:33Z
dc.date.available2012-07-16T09:47:33Z
dc.date.issued2011
dc.description.abstractBACKGROUND: 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.
dc.description.naturepublished_or_final_version
dc.identifier.citationNew England Journal Of Medicine, 2011, v. 365 n. 24, p. 2268-2276 [How to Cite?]
DOI: http://dx.doi.org/10.1056/NEJMoa1109867
dc.identifier.doihttp://dx.doi.org/10.1056/NEJMoa1109867
dc.identifier.epage2276
dc.identifier.hkuros201292
dc.identifier.isiWOS:000298031800007
dc.identifier.issn0028-4793
2011 Impact Factor: 53.298
2011 SCImago Journal Rankings: 3.412
dc.identifier.issue24
dc.identifier.pmid22082198
dc.identifier.scopuseid_2-s2.0-84855163167
dc.identifier.spage2268
dc.identifier.urihttp://hdl.handle.net/10722/152752
dc.identifier.volume365
dc.languageeng
dc.publisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/
dc.publisher.placeUnited States
dc.relation.ispartofNew England Journal of Medicine
dc.relation.referencesReferences in Scopus
dc.rightsCreative Commons: Attribution 3.0 Hong Kong License
dc.titleDronedarone in high-risk permanent atrial fibrillation
dc.typeArticle
Author Affiliations
  1. Kardinia House
  2. Universitario La Paz
  3. Care Hospital Hyderabad
  4. Instituto de Investigaciones Clínicas de Rosario
  5. Duke University School of Medicine
  6. Københavns Universitet
  7. Carmel Medical Center
  8. USSR Cardiology Research Center
  9. Veterans General Hospital-Taipei
  10. The Mount Sinai Medical Center
  11. St. John's Medical College
  12. Institutu Klinické a Experimentální Medicíny
  13. Faculty of Medicine, Ramathibodi Hospital, Mahidol University
  14. Ospedale Maggiore
  15. CHU Montpellier
  16. National Heart Centre, Singapore
  17. Universidad de la Frontera
  18. Universitätsklinikum Mannheim
  19. Saint Michael's Hospital, Toronto
  20. Zhongshan Hospital Shanghai
  21. Philippine General Hospital
  22. Population Health Research Institute, Ontario
  23. UZ Gasthuisberg
  24. Panepistimio Kritis
  25. University of Auckland
  26. Estudios Clínicos Latino América
  27. null
  28. UniversitätsSpital Bern
  29. Imperial College London
  30. Amphia Hospital
  31. Samsung Medical Center, Sungkyunkwan University
  32. Universitatea de Medicina si Farmacie Carol Davila din Bucuresti
  33. Akademiska Sjukhuset
  34. St George's University of London
  35. Queen Mary Hospital Hong Kong
  36. Helse Bergen Haukeland University Hospital
  37. St. John of God Hospital
  38. Sunnybrook Health Sciences Center
  39. Estudios Clínicos Latinoamérica
  40. Szpital Grochowski, Warszawa
  41. Sarawak General Hospital
  42. Derer 's University Hospital Slovakia
  43. Instituto Nacional de Cardiologia Ignacio Chavez
  44. Institute of Cardiology
  45. null
  46. University of Missouri System
  47. University of Cape Town
  48. Helsinki University Central Hospital