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Association of risk factors and bleeding complications in Asian patients taking edoxaban
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  • Ok Sang Lee,
  • Woorim Kim,
  • Bo Min Jang,
  • Kyung Hyun Min,
  • Yoon Sook Cho,
  • Myung Koo Lee,
  • Sandy Rhie,
  • Kyung Eun Lee
Ok Sang Lee
Chungbuk National University
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Woorim Kim
Chungbuk National University
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Bo Min Jang
Seoul National University Hospital
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Kyung Hyun Min
Chungbuk National University
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Yoon Sook Cho
Seoul National University Hospital
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Myung Koo Lee
Chungbuk National University
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Sandy Rhie
Ewha Womans University
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Kyung Eun Lee
Chungbuk National University
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Abstract

Aim: Asian patients are known to be more prone to bleeding complications than patients of other ethnicities. Therefore, there are possibilities of other risk factors that should be given special consideration for dosage adjustment in this specific ethnic group. This study aimed to investigate the risk factors for bleeding complications in Asian patients under appropriate edoxaban dosage regimens. Methods: Data on patients taking proper dosages, based on the Lixiana package insert, were analyzed. Univariate and multivariable analyses were conducted to evaluate associations between risk factors and bleeding outcomes. Subgroup analysis was performed on high-risk patients for bleeding complications whose edoxaban dose was reduced according to the package insert. Results: A total of 346 patients were included. Among them, 32 patients experienced bleeding complications. Patients with either weights of less than or equal to 60 kg and with cancer showed around 3.3- and 3.4-fold increased risk of bleeding complications compared to heavier patients ( > 60 kg) and those without cancer, respectively. In subgroup analysis with high-risk patients who took low-dose edoxaban (15 mg and 30 mg), weights of less than or equal to 60 kg remained a significant factor for bleeding outcomes. Conclusion: This study showed that weights of less than or equal to 60 kg and the presence of cancers could affect bleeding complications which occurred despite proper edoxaban treatment in Asian patients. Therefore, more strict dosage guideline could be considered in populations with high proportions of Asian ethnicities.

Peer review status:IN REVISION

05 Jul 2020Submitted to British Journal of Clinical Pharmacology
06 Jul 2020Assigned to Editor
06 Jul 2020Submission Checks Completed
07 Jul 2020Reviewer(s) Assigned
03 Sep 2020Review(s) Completed, Editorial Evaluation Pending
04 Sep 2020Editorial Decision: Revise Major