Off-label dosing of non–vitamin K antagonist oral anticoagulants and clinical outcomes in Asian patients with atrial fibrillation

Off-label dosing non–vitamin K antagonist oral anticoagulants (NOACs) are commonly prescribed for Asian patients with atrial fibrillation (AF). The purpose of this study was to investigate the associations between inappropriate dosing of NOACs and clinical outcomes. We used medical data from a multi...

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Veröffentlicht in:Heart rhythm 2020-12, Vol.17 (12), p.2102-2110
Hauptverfasser: Chan, Yi-Hsin, Chao, Tze-Fan, Chen, Shao-Wei, Lee, Hsin-Fu, Yeh, Yung-Hsin, Huang, Ya-Chi, Chang, Shang-Hung, Kuo, Chi-Tai, Lip, Gregory Y.H., Chen, Shih-Ann
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container_end_page 2110
container_issue 12
container_start_page 2102
container_title Heart rhythm
container_volume 17
creator Chan, Yi-Hsin
Chao, Tze-Fan
Chen, Shao-Wei
Lee, Hsin-Fu
Yeh, Yung-Hsin
Huang, Ya-Chi
Chang, Shang-Hung
Kuo, Chi-Tai
Lip, Gregory Y.H.
Chen, Shih-Ann
description Off-label dosing non–vitamin K antagonist oral anticoagulants (NOACs) are commonly prescribed for Asian patients with atrial fibrillation (AF). The purpose of this study was to investigate the associations between inappropriate dosing of NOACs and clinical outcomes. We used medical data from a multicenter health care system in Taiwan, which included 2068, 5135, 2589, 1483, and 2342 AF patients taking dabigatran, rivaroxaban, apixaban, edoxaban, and warfarin, respectively. The risks of ischemic stroke/systemic embolism (IS/SE) and major bleeding in patients treated with underdosing or overdosing NOACs were compared to those of on-label dosing NOACs and warfarin. About 27% and 5% of AF patients were treated with underdosing and overdosing NOACs, respectively. Compared to on-label dosing, underdosing NOACs were associated with a significantly higher risk of IS/SE (adjusted hazard ratio [aHR] 1.59; 95% confidence interval [CI] 1.25–2.02; P
doi_str_mv 10.1016/j.hrthm.2020.07.022
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The purpose of this study was to investigate the associations between inappropriate dosing of NOACs and clinical outcomes. We used medical data from a multicenter health care system in Taiwan, which included 2068, 5135, 2589, 1483, and 2342 AF patients taking dabigatran, rivaroxaban, apixaban, edoxaban, and warfarin, respectively. The risks of ischemic stroke/systemic embolism (IS/SE) and major bleeding in patients treated with underdosing or overdosing NOACs were compared to those of on-label dosing NOACs and warfarin. About 27% and 5% of AF patients were treated with underdosing and overdosing NOACs, respectively. Compared to on-label dosing, underdosing NOACs were associated with a significantly higher risk of IS/SE (adjusted hazard ratio [aHR] 1.59; 95% confidence interval [CI] 1.25–2.02; P &lt;.001), whereas overdosing NOACs were associated with a significantly higher risk of major bleeding (aHR 2.01; 95% CI 1.13–3.56; P = .017). Compared to warfarin, the 4 on-label dosing NOACs were associated with a comparable risk of IS/SE and a significantly lower risk of major bleeding, whereas underdosing NOACs were associated with a higher risk of IS/SE (aHR 1.46; P = .012). About 3 in 10 Asian AF patients were treated with off-label dosing NOACs in daily practice. Compared to on-label dosing, underdosing was associated with a higher risk of IS/SE, whereas overdosing was associated with a higher risk of major bleeding. Thus, even for Asian AF patients at higher risk for bleeding, NOACs still should be prescribed at the dosing based on clinical trial criteria and guideline recommendations.</description><identifier>ISSN: 1547-5271</identifier><identifier>EISSN: 1556-3871</identifier><identifier>DOI: 10.1016/j.hrthm.2020.07.022</identifier><identifier>PMID: 32702416</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Asian ; Atrial fibrillation ; Dosing ; Non–vitamin K antagonist oral anticoagulant ; Outcomes</subject><ispartof>Heart rhythm, 2020-12, Vol.17 (12), p.2102-2110</ispartof><rights>2020 Heart Rhythm Society</rights><rights>Copyright © 2020 Heart Rhythm Society. Published by Elsevier Inc. 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The purpose of this study was to investigate the associations between inappropriate dosing of NOACs and clinical outcomes. We used medical data from a multicenter health care system in Taiwan, which included 2068, 5135, 2589, 1483, and 2342 AF patients taking dabigatran, rivaroxaban, apixaban, edoxaban, and warfarin, respectively. The risks of ischemic stroke/systemic embolism (IS/SE) and major bleeding in patients treated with underdosing or overdosing NOACs were compared to those of on-label dosing NOACs and warfarin. About 27% and 5% of AF patients were treated with underdosing and overdosing NOACs, respectively. Compared to on-label dosing, underdosing NOACs were associated with a significantly higher risk of IS/SE (adjusted hazard ratio [aHR] 1.59; 95% confidence interval [CI] 1.25–2.02; P &lt;.001), whereas overdosing NOACs were associated with a significantly higher risk of major bleeding (aHR 2.01; 95% CI 1.13–3.56; P = .017). Compared to warfarin, the 4 on-label dosing NOACs were associated with a comparable risk of IS/SE and a significantly lower risk of major bleeding, whereas underdosing NOACs were associated with a higher risk of IS/SE (aHR 1.46; P = .012). About 3 in 10 Asian AF patients were treated with off-label dosing NOACs in daily practice. Compared to on-label dosing, underdosing was associated with a higher risk of IS/SE, whereas overdosing was associated with a higher risk of major bleeding. Thus, even for Asian AF patients at higher risk for bleeding, NOACs still should be prescribed at the dosing based on clinical trial criteria and guideline recommendations.</description><subject>Asian</subject><subject>Atrial fibrillation</subject><subject>Dosing</subject><subject>Non–vitamin K antagonist oral anticoagulant</subject><subject>Outcomes</subject><issn>1547-5271</issn><issn>1556-3871</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNp9kM1u1DAQgC0EoqXwBEjIRy4JthP_5MChqqAgKvUCZ8t2nN1ZJfZiO0XckHiEviFPgsMWjlzsGc03Hs-H0EtKWkqoeHNo96nsl5YRRloiW8LYI3ROORdNpyR9vMW9bDiT9Aw9y_lACBsE6Z6is45JwnoqztHP22lqZmP9jMeYIexwnHCI4deP-zsoZoGAP2ETitnFALngmMy85eCi2a1zjXJNR-xmCOBqLa7FxcVnXDsvM5iAj6aA37hvUPbYlAQVm8AmmOdaiuE5ejKZOfsXD_cF-vL-3eerD83N7fXHq8ubxnV8KI0ygxCKe04FIWYY6mH4pOpOhisrpXXCM2GFHcbem8HRoedEqU5ZyxkVrrtAr0_vHlP8uvpc9ALZ-fqL4OOaNeuZ7Ajnile0O6EuxZyTn_QxwWLSd02J3uzrg_5jX2_2NZG62q9drx4GrHbx47-ev7or8PYE-LrmHfiks6tunB8heVf0GOG_A34D4-mZwA</recordid><startdate>202012</startdate><enddate>202012</enddate><creator>Chan, Yi-Hsin</creator><creator>Chao, Tze-Fan</creator><creator>Chen, Shao-Wei</creator><creator>Lee, Hsin-Fu</creator><creator>Yeh, Yung-Hsin</creator><creator>Huang, Ya-Chi</creator><creator>Chang, Shang-Hung</creator><creator>Kuo, Chi-Tai</creator><creator>Lip, Gregory Y.H.</creator><creator>Chen, Shih-Ann</creator><general>Elsevier Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>202012</creationdate><title>Off-label dosing of non–vitamin K antagonist oral anticoagulants and clinical outcomes in Asian patients with atrial fibrillation</title><author>Chan, Yi-Hsin ; Chao, Tze-Fan ; Chen, Shao-Wei ; Lee, Hsin-Fu ; Yeh, Yung-Hsin ; Huang, Ya-Chi ; Chang, Shang-Hung ; Kuo, Chi-Tai ; Lip, Gregory Y.H. ; Chen, Shih-Ann</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c359t-8a96685e51600a9900aa5f8296a58b77bc6e26b6b9d4ea9c194508838bb5216c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Asian</topic><topic>Atrial fibrillation</topic><topic>Dosing</topic><topic>Non–vitamin K antagonist oral anticoagulant</topic><topic>Outcomes</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Chan, Yi-Hsin</creatorcontrib><creatorcontrib>Chao, Tze-Fan</creatorcontrib><creatorcontrib>Chen, Shao-Wei</creatorcontrib><creatorcontrib>Lee, Hsin-Fu</creatorcontrib><creatorcontrib>Yeh, Yung-Hsin</creatorcontrib><creatorcontrib>Huang, Ya-Chi</creatorcontrib><creatorcontrib>Chang, Shang-Hung</creatorcontrib><creatorcontrib>Kuo, Chi-Tai</creatorcontrib><creatorcontrib>Lip, Gregory Y.H.</creatorcontrib><creatorcontrib>Chen, Shih-Ann</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Heart rhythm</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Chan, Yi-Hsin</au><au>Chao, Tze-Fan</au><au>Chen, Shao-Wei</au><au>Lee, Hsin-Fu</au><au>Yeh, Yung-Hsin</au><au>Huang, Ya-Chi</au><au>Chang, Shang-Hung</au><au>Kuo, Chi-Tai</au><au>Lip, Gregory Y.H.</au><au>Chen, Shih-Ann</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Off-label dosing of non–vitamin K antagonist oral anticoagulants and clinical outcomes in Asian patients with atrial fibrillation</atitle><jtitle>Heart rhythm</jtitle><addtitle>Heart Rhythm</addtitle><date>2020-12</date><risdate>2020</risdate><volume>17</volume><issue>12</issue><spage>2102</spage><epage>2110</epage><pages>2102-2110</pages><issn>1547-5271</issn><eissn>1556-3871</eissn><abstract>Off-label dosing non–vitamin K antagonist oral anticoagulants (NOACs) are commonly prescribed for Asian patients with atrial fibrillation (AF). 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Atrial fibrillation
Dosing
Non–vitamin K antagonist oral anticoagulant
Outcomes
title Off-label dosing of non–vitamin K antagonist oral anticoagulants and clinical outcomes in Asian patients with atrial fibrillation
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