Off-label reduced-dose apixaban does not reduce hemorrhagic risk in Taiwanese patients with nonvalvular atrial fibrillation A retrospective, observational study

doi:10.1097/MD.0000000000026272

CNU IR > Pharmacy and Science > Dept. of Pharmacy > Periodical Articles > Item 310902800/34408

Please use this identifier to cite or link to this item: https://ir.cnu.edu.tw/handle/310902800/34408

Title:	Off-label reduced-dose apixaban does not reduce hemorrhagic risk in Taiwanese patients with nonvalvular atrial fibrillation A retrospective, observational study
Authors:	Chen, I-Chih Chang, Wei-Ting Hsu, Po-Chao Yeh, Ya-Lan Zheng, Syuan Huang, Yuan-Chi Lin, Chih-Hsien Tsai, Liang-Miin Lin, Li-Jen Liu, Ping-Yen Liu, Yen-Wen
Contributors:	Tainan Municipal Hosp, Div Cardiol, Dept Internal Med Chia Nan Univ Pharm & Sci, Dept Pharm Chi Mei Med Ctr, Div Cardiol, Dept Internal Med Southern Taiwan Univ Sci & Technol, Dept Biotechnol Kaohsiung Med Univ, Kaohsiung Med Univ Hosp, Div Cardiol, Dept Internal Med Chang Gung Univ Sci & Technol, Chiayi Campus Natl Cheng Kung Univ Hosp, Dept Med Natl Cheng Kung Univ Hosp, Dept Internal Med, Div Cardiol Natl Cheng Kung Univ, Coll Med, Inst Clin Med
Keywords:	direct oral anticoagulant nonvalvular atrial fibrillation off-label reduced-dose apixaban stroke
Date:	2021
Issue Date:	2023-11-11 11:50:20 (UTC+8)
Publisher:	LIPPINCOTT WILLIAMS & WILKINS
Abstract:	East Asians are reportedly at high risk of anticoagulant-related bleeding; therefore, some physicians prefer to prescribe low-dose direct oral anticoagulants (DOACs). Little is known about the therapeutic effectiveness and safety of off-label reduced-dose apixaban in East Asians with nonvalvular atrial fibrillation (AF). We aimed to investigate the effectiveness and safety of off-label reduced-dose apixaban in Taiwanese patients with nonvalvular AF. This retrospective cohort study enrolled 1073 patients with nonvalvular AF who took apixaban between July 2014 and October 2018 from 4 medical centers in southern Taiwan. The primary outcomes included thromboembolic events (stroke/transient ischemic attack or systemic embolism), major bleeding, and all-cause mortality. Among all patients, 826 (77%) patients were classified as the per-label adequate-dose treatment group (i.e., consistent with the Food and Drug Administration label recommendations) while 247 (23%) patients were the off-label reduced-dose treatment group. The mean follow-up period was 17.5 +/- 13 months. The off-label reduced-dose group did not have a lower major bleeding rate than the per-label adequate-dose group (4.8% vs 3.8%, adjusted hazard ratio [HR] 1.20, 95% confidence interval [CI] 0.69-2.09), but had a nonsignificantly higher incidence of thromboembolic events (4.23% vs 3.05%, adjusted HR: 1.29, 95% CI: 0.71-2.34). An off-label reduced-dose apixaban treatment strategy may not provide incremental benefits or safety for Taiwanese patients with nonvalvular AF.
Relation:	MEDICINE, v.100, n.23, e26272
Appears in Collections:	[Dept. of Pharmacy] Periodical Articles

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