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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, C39
Alings, M31
Amerena, J2
Atar, D37
Avezum, Á41
Blomström, P36
Borggrefe, M18
Budaj, A43
Chen, SA9
Ching, CK20
Commerford, P47
Dans, A25
Davy, JM17
Delacrétaz, E32
Di Pasquale, G15
Diaz, R26
Dorian, P16
Flaker, G42
Golitsyn, S8
GonzalezHermosillo, A45
Granger, CB5
Heidbüchel, H23
Kautzner, J12
Kim, JS27
Lanas, F21
Lewis, BS7
Merino, JL1
Morillo, C22
Murin, J14
Narasimhan, C3
Paolasso, E4
Parkhomenko, A44
Peters, NS33
Sim, KH40
Stiles, MK29
Tanomsup, S13
Toivonen, L48
Tomcsányi, J38
TorpPedersen, C6
Tse, HF35
Vardas, P24
Vinereanu, D28
Xavier, D11
Zhu, J
Zhu, JR19
BaretCormel, L46
Weinling, E46
Staiger, C46
Yusuf, S22
Chrolavicius, S22
Afzal, R22
Hohnloser, SH30
 
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
2013 Impact Factor: 54.420
 
DOIhttp://dx.doi.org/10.1056/NEJMoa1109867
 
ISI Accession Number IDWOS:000298031800007
 
ReferencesReferences in Scopus
 
DC FieldValue
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
 
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dc.identifier.hkuros201292
 
dc.identifier.isiWOS:000298031800007
 
dc.identifier.issn0028-4793
2013 Impact Factor: 54.420
 
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
 
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<contributor.author>Chrolavicius, S</contributor.author>
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<description.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.) Copyright &#169; 2011 Massachusetts Medical Society. All rights reserved.</description.abstract>
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Author Affiliations
  1. Universitario La Paz
  2. Kardinia House
  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. Faculty Hospital of Comenius University
  15. Ospedale Maggiore
  16. Saint Michael's Hospital University of Toronto
  17. CHU Montpellier
  18. Universitätsklinikum Mannheim
  19. Zhongshan Hospital Shanghai
  20. National Heart Centre, Singapore
  21. Universidad de la Frontera
  22. Population Health Research Institute, Ontario
  23. UZ Gasthuisberg
  24. Panepistimio Kritis
  25. Philippine General Hospital
  26. Estudios Clinicos Latino America
  27. Samsung Medical Center, Sungkyunkwan University
  28. Universitatea de Medicina si Farmacie Carol Davila din Bucuresti
  29. University of Auckland
  30. null
  31. Amphia Hospital
  32. UniversitätsSpital Bern
  33. Imperial College London
  34. St George's University of London
  35. Queen Mary Hospital Hong Kong
  36. Akademiska Sjukhuset
  37. Helse Bergen Haukeland University Hospital
  38. St. John of God Hospital
  39. Sunnybrook Health Sciences Center
  40. Sarawak General Hospital
  41. Estudios Clínicos Latinoamérica
  42. University of Missouri-Columbia
  43. Szpital Grochowski, Warszawa
  44. Institute of Cardiology
  45. Instituto Nacional de Cardiologia Ignacio Chavez
  46. null
  47. University of Cape Town
  48. Helsinki University Central Hospital