Accepted Manuscript Does Digoxin Increase the Risk of Ischemic Stroke and Mortality in Atrial Fibrillation? – A Nationwide Population-Based Cohort Study Tze-Fan Chao , M.D. Chia-Jen Liu , M.D. Su-Jung Chen , M.D. Kang-Ling Wang , M.D. Yenn-Jiang Lin , M.D. Shih-Lin Chang , M.D. Li-Wei Lo , M.D. Yu-Feng Hu , M.D. Ta-Chuan Tuan , M.D. Tzeng-Ji Chen , M.D. Chern-En Chiang , M.D., Ph.D. Shih-Ann Chen , M.D. PII:

S0828-282X(14)00352-3

DOI:

10.1016/j.cjca.2014.05.009

Reference:

CJCA 1220

To appear in:

Canadian Journal of Cardiology

Received Date: 10 January 2014 Revised Date:

12 May 2014

Accepted Date: 12 May 2014

Please cite this article as: Chao T-F, Liu C-J, Chen S-J, Wang K-L, Lin Y-J, Chang S-L, Lo L-W, Hu Y-F, Tuan T-C, Chen T-J, Chiang C-E, Chen S-A, Does Digoxin Increase the Risk of Ischemic Stroke and Mortality in Atrial Fibrillation? – A Nationwide Population-Based Cohort Study, Canadian Journal of Cardiology (2014), doi: 10.1016/j.cjca.2014.05.009. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

ACCEPTED MANUSCRIPT

Does Digoxin Increase the Risk of Ischemic Stroke and Mortality in Atrial Fibrillation? – A Nationwide Population-Based Cohort Study Tze-Fan Chao, M.D.1,2, Chia-Jen Liu, M.D.3,4,5, Su-Jung Chen, M.D.4,6, Kang-Ling Wang,

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M.D.1,2, Yenn-Jiang Lin, M.D.1,2, Shih-Lin Chang, M.D.1,2, Li-Wei Lo, M.D.1,2, Yu-Feng Hu, M.D.1,2, Ta-Chuan Tuan, M.D.1,2,, Tzeng-Ji Chen, M.D.7, Chern-En Chiang, M.D., Ph.D.1,2,8,9 and Shih-Ann Chen, M.D.1,2

Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taipei,

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Taiwan. 2Institute of Clinical Medicine, and Cardiovascular Research Center, National Yang-

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Ming University, Taipei, Taiwan. 3Division of Hematology and Oncology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. 4Institute of Public Health and School of Medicine, National Yang-Ming University, Taipei, Taiwan. 5Department of Internal Medicine, National Yang-Ming University Hospital, I-Lan, Taiwan. 6Division of Infectious Diseases, Department of Medicine, Taipei Veterans General Hospital Su-Ao and Yuanshan branch, I-Lan, Taiwan. 7Department of Family Medicine, Taipei Veterans General

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Hospital, Taipei, Taiwan. 8General Clinical Research Center, Taipei Veterans General Hospital, Taipei, Taiwan. 9Department of Medical Research and Education, Taipei Veterans General Hospital, Taipei, Taiwan.

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Dr Tze-Fan Chao and Dr Chia-Jen Liu contributed equally to this study

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Running title: digoxin and AF Total word count: 4,404

Address for correspondence Chern-En Chiang, M.D., Ph.D., FACC, FESC General Clinical Research Center, Taipei Veterans General Hospital No. 201, Sec. 2, Shih-Pai Road, Taipei, Taiwan. 1

ACCEPTED MANUSCRIPT Tel: 866-2-2875-7774 Fax: 886-2-2874-5422 E-Mail: [email protected]

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Shih-Ann Chen, M.D.

Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, No. 201, Sec. 2, Shih-Pai Road, Taipei, Taiwan.

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Tel: 886-2-2875-7156

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E-Mail: [email protected]

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Fax: 886-2-2873-5656

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ACCEPTED MANUSCRIPT Brief Summary Among patients with atrial fibrillation (AF), digoxin use was associated with an increased risk of ischemic stroke and mortality for patients without heart failure, but not for

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those with heart failure. Among AF patients without heart failure, the use of beta-blockers seemed to have survival benefits. For controlling ventricular rate in AF patients without heart failure, digoxin should be used “with caution” and beta-blockers may be a better choice for

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primary rate control therapy.

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ACCEPTED MANUSCRIPT Abstract Background: Digoxin and related cardiac glycoside have been used for almost 100 years in atrial fibrillation (AF). However, recent 2 analyses of the “AFFIRM” trial showed nonconsistent results about the risk of mortality associated with digoxin use. The goal of the

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present study is to investigate the relationship between digoxin and the risk of ischemic stroke and mortality in Asians.

Methods: This study used the “National Health Insurance Research Database” in Taiwan. A

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total of 4,781 AF patients who did not receive any antithrombotic therapy were selected as

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the study population. Among the study population, 829 subjects (17.3%) received the digoxin treatment. The risks of ischemic stroke and mortality of patients with or without digoxin use were compared.

Results: The use of digoxin was associated with an increased risk of clinical events with an

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adjusted hazard ratio of 1.41 (95% CI =1.17-1.70) for ischemic stroke and 1.21 (95% CI =1.01-1.44) for all-cause mortality. In the subgroup analysis based on the coexistence with heart failure or not, digoxin was a risk factor of adverse events for patients without heart

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failure, but not for those with heart failure (interaction p

Does digoxin increase the risk of ischemic stroke and mortality in atrial fibrillation? A nationwide population-based cohort study.

Digoxin and related cardiac glycosides have been used for almost 100 years in atrial fibrillation (AF). However, 2 recent analyses of the Atrial Fibri...
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