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Article: Dronedarone in high-risk permanent atrial fibrillation

TitleDronedarone in high-risk permanent atrial fibrillation
Authors
Issue Date2011
PublisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/
Citation
New England Journal Of Medicine, 2011, v. 365 n. 24, p. 2268-2276 How to Cite?
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.
Persistent Identifierhttp://hdl.handle.net/10722/152752
ISSN
2014 Impact Factor: 55.873
2014 SCImago Journal Rankings: 12.155
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorConnolly, SJen_HK
dc.contributor.authorCamm, AJen_HK
dc.contributor.authorHalperin, JLen_HK
dc.contributor.authorJoyner, Cen_HK
dc.contributor.authorAlings, Men_HK
dc.contributor.authorAmerena, Jen_HK
dc.contributor.authorAtar, Den_HK
dc.contributor.authorAvezum, Áen_HK
dc.contributor.authorBlomström, Pen_HK
dc.contributor.authorBorggrefe, Men_HK
dc.contributor.authorBudaj, Aen_HK
dc.contributor.authorChen, SAen_HK
dc.contributor.authorChing, CKen_HK
dc.contributor.authorCommerford, Pen_HK
dc.contributor.authorDans, Aen_HK
dc.contributor.authorDavy, JMen_HK
dc.contributor.authorDelacrétaz, Een_HK
dc.contributor.authorDi Pasquale, Gen_HK
dc.contributor.authorDiaz, Ren_HK
dc.contributor.authorDorian, Pen_HK
dc.contributor.authorFlaker, Gen_HK
dc.contributor.authorGolitsyn, Sen_HK
dc.contributor.authorGonzalezHermosillo, Aen_HK
dc.contributor.authorGranger, CBen_HK
dc.contributor.authorHeidbüchel, Hen_HK
dc.contributor.authorKautzner, Jen_HK
dc.contributor.authorKim, JSen_HK
dc.contributor.authorLanas, Fen_HK
dc.contributor.authorLewis, BSen_HK
dc.contributor.authorMerino, JLen_HK
dc.contributor.authorMorillo, Cen_HK
dc.contributor.authorMurin, Jen_HK
dc.contributor.authorNarasimhan, Cen_HK
dc.contributor.authorPaolasso, Een_HK
dc.contributor.authorParkhomenko, Aen_HK
dc.contributor.authorPeters, NSen_HK
dc.contributor.authorSim, KHen_HK
dc.contributor.authorStiles, MKen_HK
dc.contributor.authorTanomsup, Sen_HK
dc.contributor.authorToivonen, Len_HK
dc.contributor.authorTomcsányi, Jen_HK
dc.contributor.authorTorpPedersen, Cen_HK
dc.contributor.authorTse, HFen_HK
dc.contributor.authorVardas, Pen_HK
dc.contributor.authorVinereanu, Den_HK
dc.contributor.authorXavier, Den_HK
dc.contributor.authorZhu, Jen_HK
dc.contributor.authorZhu, JRen_HK
dc.contributor.authorBaretCormel, Len_HK
dc.contributor.authorWeinling, Een_HK
dc.contributor.authorStaiger, Cen_HK
dc.contributor.authorYusuf, Sen_HK
dc.contributor.authorChrolavicius, Sen_HK
dc.contributor.authorAfzal, Ren_HK
dc.contributor.authorHohnloser, SHen_HK
dc.date.accessioned2012-07-16T09:47:33Z-
dc.date.available2012-07-16T09:47:33Z-
dc.date.issued2011en_HK
dc.identifier.citationNew England Journal Of Medicine, 2011, v. 365 n. 24, p. 2268-2276en_HK
dc.identifier.issn0028-4793en_HK
dc.identifier.urihttp://hdl.handle.net/10722/152752-
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.en_HK
dc.languageengen_US
dc.publisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/en_HK
dc.relation.ispartofNew England Journal of Medicineen_HK
dc.rightsCreative Commons: Attribution 3.0 Hong Kong License-
dc.titleDronedarone in high-risk permanent atrial fibrillationen_HK
dc.typeArticleen_HK
dc.identifier.emailTse, HF:hftse@hkucc.hku.hken_HK
dc.identifier.authorityTse, HF=rp00428en_HK
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1056/NEJMoa1109867en_HK
dc.identifier.pmid22082198-
dc.identifier.scopuseid_2-s2.0-84855163167en_HK
dc.identifier.hkuros201292en_US
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-84855163167&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume365en_HK
dc.identifier.issue24en_HK
dc.identifier.spage2268en_HK
dc.identifier.epage2276en_HK
dc.identifier.isiWOS:000298031800007-
dc.publisher.placeUnited Statesen_HK
dc.identifier.f100013411046-
dc.identifier.scopusauthoridConnolly, SJ=18533896400en_HK
dc.identifier.scopusauthoridCamm, AJ=7202602504en_HK
dc.identifier.scopusauthoridHalperin, JL=7102699317en_HK
dc.identifier.scopusauthoridJoyner, C=26642933900en_HK
dc.identifier.scopusauthoridAlings, M=25631846400en_HK
dc.identifier.scopusauthoridAmerena, J=6603684781en_HK
dc.identifier.scopusauthoridAtar, D=7005111567en_HK
dc.identifier.scopusauthoridAvezum, Á=7003859797en_HK
dc.identifier.scopusauthoridBlomström, P=7003475954en_HK
dc.identifier.scopusauthoridBorggrefe, M=35380094100en_HK
dc.identifier.scopusauthoridBudaj, A=7003789333en_HK
dc.identifier.scopusauthoridChen, SA=39461009500en_HK
dc.identifier.scopusauthoridChing, CK=14038646100en_HK
dc.identifier.scopusauthoridCommerford, P=7003697293en_HK
dc.identifier.scopusauthoridDans, A=6602316205en_HK
dc.identifier.scopusauthoridDavy, JM=7101674587en_HK
dc.identifier.scopusauthoridDelacrétaz, E=7003281733en_HK
dc.identifier.scopusauthoridDi Pasquale, G=7007052574en_HK
dc.identifier.scopusauthoridDiaz, R=7201925889en_HK
dc.identifier.scopusauthoridDorian, P=7005356417en_HK
dc.identifier.scopusauthoridFlaker, G=7006130038en_HK
dc.identifier.scopusauthoridGolitsyn, S=7003726511en_HK
dc.identifier.scopusauthoridGonzalezHermosillo, A=14832456500en_HK
dc.identifier.scopusauthoridGranger, CB=7202019383en_HK
dc.identifier.scopusauthoridHeidbüchel, H=7004984289en_HK
dc.identifier.scopusauthoridKautzner, J=16689300200en_HK
dc.identifier.scopusauthoridKim, JS=35074215000en_HK
dc.identifier.scopusauthoridLanas, F=6701747182en_HK
dc.identifier.scopusauthoridLewis, BS=7401867678en_HK
dc.identifier.scopusauthoridMerino, JL=54418906200en_HK
dc.identifier.scopusauthoridMorillo, C=7005678781en_HK
dc.identifier.scopusauthoridMurin, J=7006920804en_HK
dc.identifier.scopusauthoridNarasimhan, C=7005033495en_HK
dc.identifier.scopusauthoridPaolasso, E=6701804490en_HK
dc.identifier.scopusauthoridParkhomenko, A=7006612617en_HK
dc.identifier.scopusauthoridPeters, NS=7202298487en_HK
dc.identifier.scopusauthoridSim, KH=8136210000en_HK
dc.identifier.scopusauthoridStiles, MK=35278667100en_HK
dc.identifier.scopusauthoridTanomsup, S=6602231931en_HK
dc.identifier.scopusauthoridToivonen, L=34573374800en_HK
dc.identifier.scopusauthoridTomcsányi, J=7004412425en_HK
dc.identifier.scopusauthoridTorpPedersen, C=7007032846en_HK
dc.identifier.scopusauthoridTse, HF=7006070805en_HK
dc.identifier.scopusauthoridVardas, P=35391927700en_HK
dc.identifier.scopusauthoridVinereanu, D=6603080279en_HK
dc.identifier.scopusauthoridXavier, D=23020407000en_HK
dc.identifier.scopusauthoridZhu, J=35363243700en_HK
dc.identifier.scopusauthoridZhu, JR=35363243700en_HK
dc.identifier.scopusauthoridBaretCormel, L=54879390300en_HK
dc.identifier.scopusauthoridWeinling, E=15123537700en_HK
dc.identifier.scopusauthoridStaiger, C=7005241378en_HK
dc.identifier.scopusauthoridYusuf, S=7202749318en_HK
dc.identifier.scopusauthoridChrolavicius, S=6506443276en_HK
dc.identifier.scopusauthoridAfzal, R=6701678903en_HK
dc.identifier.scopusauthoridHohnloser, SH=35268873900en_HK

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