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

I. Chih Chen, Wei Ting Chang, Po Chao Hsu, Ya Lan Yeh, Syuan Zheng, Yuan Chi Huang, Chih Hsien Lin, Liang Miin Tsai, Li Jen Lin, Ping Yen Liu, Yen Wen Liu

研究成果: Article同行評審

3 引文 斯高帕斯(Scopus)

摘要

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.

原文English
頁(從 - 到)E26272
期刊Medicine (United States)
100
發行號23
DOIs
出版狀態Published - 2021 6月 11

All Science Journal Classification (ASJC) codes

  • 醫藥 (全部)

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