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Label Adherence of Direct Oral Anticoagulants Dosing and Clinical Outcomes in Patients With Atrial Fibrillation

Authors
 Hee Tae Yu  ;  Pil-Sung Yang  ;  Eunsun Jang  ;  Tae-Hoon Kim  ;  Jae-Sun Uhm  ;  Jong-Youn Kim  ;  Hui-Nam Pak  ;  Moon-Hyoung Lee  ;  Gregory Y H Lip  ;  Boyoung Joung 
Citation
 JOURNAL OF THE AMERICAN HEART ASSOCIATION, Vol.9(12) : e014177, 2020-06 
Journal Title
 JOURNAL OF THE AMERICAN HEART ASSOCIATION 
Issue Date
2020-06
Keywords
atrial fibrillation ; label adherence ; non‐vitamin K antagonist oral anticoagulants ; overdosing ; underdosing.
Abstract
Background Dose adjustment of non-vitamin K antagonist oral anticoagulants (NOACs) is indicated in some patients with atrial fibrillation (AF), based on selected patient factors or concomitant medications. We assessed the frequency of label adherence of NOAC dosing among AF patients and the associations between off-label NOAC dosing and clinical outcomes. Methods and Results We evaluated 53 649 AF patients treated with an NOAC using Korean National Health Insurance Service database during the period from 2013 to 2016. NOAC doses were classified as either underdosed or overdosed, consistent with Korea Food and Drug Administration labeling. Cox proportional hazards regression was performed to investigate the effectiveness and safety outcomes including stroke or systemic embolism, major bleeding, and all-cause mortality. Overall, 16 757 NOAC-treated patients (31.2%) were underdosed, 4492 were overdosed (8.4%), and 32 400 (60.4%) were dosed appropriately according to drug labeling. Compared with patients with label adherence, those who were underdosed or overdosed were older (aged 71±8 and 75±7 years versus 70±9 years, respectively; P<0.001) and had higher CHA2DS2-VASc scores (4.6±1.7 and 5.3±1.7 versus 4.5±1.8, respectively; P<0.001). NOAC overdosing was associated with increased risk for stroke or systemic embolism (5.76 versus 4.03 events/100 patient-years, P<0.001), major bleeding (4.77 versus 2.94 events/100 patient-years, P<0.001), and all-cause mortality (5.43 versus 3.05 events/100 patient-years, P<0.001) compared with label-adherent use. Conclusions In real-world practice, a significant proportion (almost 2 in 5) of AF patients received NOAC doses inconsistent with drug labeling. NOAC overdosing is associated with worse clinical outcomes in Asian AF patients.
Files in This Item:
T202002196.pdf Download
DOI
10.1161/JAHA.119.014177
Appears in Collections:
1. College of Medicine (의과대학) > BioMedical Science Institute (의생명과학부) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Jong Youn(김종윤) ORCID logo https://orcid.org/0000-0001-7040-8771
Kim, Tae-Hoon(김태훈) ORCID logo https://orcid.org/0000-0003-4200-3456
Pak, Hui Nam(박희남) ORCID logo https://orcid.org/0000-0002-3256-3620
Uhm, Jae Sun(엄재선) ORCID logo https://orcid.org/0000-0002-1611-8172
Yu, Hee Tae(유희태) ORCID logo https://orcid.org/0000-0002-6835-4759
Lee, Moon-Hyoung(이문형) ORCID logo https://orcid.org/0000-0002-7268-0741
Jang, Eunsun(장은선) ORCID logo https://orcid.org/0000-0001-6991-4765
Joung, Bo Young(정보영) ORCID logo https://orcid.org/0000-0001-9036-7225
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/179311
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