High incidence of major bleeding with off-label use of edoxaban

• Fukui Rika

  Department of Pharmacy, Shiga University of Medical Science Hospital

• Hira Daiki

  Department of Pharmacy, Shiga University of Medical Science Hospital College of Pharmaceutical Sciences, Ritsumeikan University

• Kunitsu Yuki

  Department of Pharmacy, Shiga University of Medical Science Hospital

• Isono Tetsuichiro

  Department of Pharmacy, Shiga University of Medical Science Hospital

• Tabuchi Yohei

  Department of Pharmacy, Shiga University of Medical Science Hospital

• Ikuno Yoshihiro

  Department of Pharmacy, Shiga University of Medical Science Hospital Medical Safety Section, Shiga University of Medical Science Hospital

• Ueshima Satoshi

  College of Pharmaceutical Sciences, Ritsumeikan University

• Itoh Hideki

  Division of Patient Safety, Hiroshima University Hospital Department of Cardiovascular Medicine, Shiga University of Medical Science Hospital

• Tanaka Toshihiro

  Medical Safety Section, Shiga University of Medical Science Hospital Department of Dermatology, Shiga University of Medical Science Hospital

• Terada Tomohiro

  Department of Pharmacy, Shiga University of Medical Science Hospital

抄録

In clinical practice, edoxaban is sometimes prescribed for off-label use based on the hypothesis that it is as safe and effective as warfarin. However, there is limited safety information on off-label use due to lack of clinical trial. We aimed to analyze the tolerability of off-label use of edoxaban and to identify patient characteristics associated with major bleeding as adverse effects. Patients under edoxaban treatment between January 2017 and December 2017 were enrolled in this retrospective cohort study. The incidence of major bleeding with off-label use compared with on-label use was analyzed using by log-rank test. Univariate and multivariate regression analysis were undertaken to detect independent variables with significant odds ratio that associated with major bleeding. After the exclusion criteria were applied, the patients were divided into two groups: off-label group (n = 30) and on-label group (n = 161). Incidence of major bleeding was found to be higher in the off-label group (13.3%) than in the on-label group (3.7%) (p<0.05). Multivariate adjustment showed that the off-label use or portal vein thrombosis and patients with history of major bleeding has significantly higher incidence of major bleeding. We demonstrated that off-label use of edoxaban may be a significant risk factor for major bleeding.

収録刊行物

• Ｊｏｕｒｎａｌ　ｏｆ　Ｃｌｉｎｉｃａｌ　Ｂｉｏｃｈｅｍｉｓｔｒｙ　ａｎｄ　Ｎｕｔｒｉｔｉｏｎ

  Ｊｏｕｒｎａｌ　ｏｆ　Ｃｌｉｎｉｃａｌ　Ｂｉｏｃｈｅｍｉｓｔｒｙ　ａｎｄ　Ｎｕｔｒｉｔｉｏｎ advpub (0), 311-316, 2021

  一般社団法人　日本酸化ストレス学会

キーワード

• direct oral anticoagulants
• edoxaban
• anticoagulants
• off-label
• bleeding

詳細情報

• CRID: 1390288457807461120
• NII論文ID: 130008110266
• DOI: 10.3164/jcbn.21-9
• ISSN: 18805086
• ISSN: 09120009
• Web Site: http://hdl.handle.net/10422/00013149
• Web Site: https://www.jstage.jst.go.jp/article/jcbn/69/3/69_21-9/_pdf
• Web Site: https://search.jamas.or.jp/link/ui/2022251477
• 本文言語コード: en
• データソース種別:
  • JaLC
  • IRDB
  • Crossref
  • CiNii Articles
  • KAKEN
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