Prescribing Patterns and Outcomes of Edoxaban in Atrial Fibrillation: One-Year Data from the Global ETNA-AF Program

Tze-Fan Chao; Martin Unverdorben; Paulus Kirchhof; Yukihiro Koretsune; Takeshi Yamashita; Robert A Crozier; Ladislav Pecen; Cathy Chen; Amanda P Borrow; Raffaele De Caterina

doi:10.3390/jcm12051870

Prescribing Patterns and Outcomes of Edoxaban in Atrial Fibrillation: One-Year Data from the Global ETNA-AF Program

J Clin Med. 2023 Feb 27;12(5):1870. doi: 10.3390/jcm12051870.

Authors

Tze-Fan Chao^{1

2}, Martin Unverdorben³, Paulus Kirchhof^{4

5

6}, Yukihiro Koretsune⁷, Takeshi Yamashita⁸, Robert A Crozier³, Ladislav Pecen⁹, Cathy Chen³, Amanda P Borrow³, Raffaele De Caterina^{10

11}

Affiliations

¹ Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taipei 11220, Taiwan.
² Institute of Clinical Medicine, Cardiovascular Research Center, National Yang Ming Chiao Tung University, Taipei 11217, Taiwan.
³ Global Specialty Medical Affairs, Daiichi Sankyo, Inc., Basking Ridge, NJ 07920, USA.
⁴ Department of Cardiology, University Heart and Vascular Centre Hamburg, University Medical Center Hamburg-Eppendorf, 20246 Hamburg, Germany.
⁵ German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, 20246 Hamburg, Germany.
⁶ Institute of Cardiovascular Sciences, University of Birmingham, IBR 136, Wolfson Drive, Birmingham B15 2TT, UK.
⁷ Cardiovascular Division, National Hospital Organization Osaka National Hospital, Osaka 540-0006, Japan.
⁸ Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo 106-0031, Japan.
⁹ Institute of Computer Science, Academy of Sciences of the Czech Republic, 18207 Prague, Czech Republic.
¹⁰ Pisa University Hospital, University of Pisa, 56126 Pisa, Italy.
¹¹ Fondazione VillaSerena per la Ricerca, 65013 Città Sant'Angelo, Italy.

Abstract

Non-recommended dosing occurs in ~25-50% of non-vitamin K antagonist oral anticoagulant prescriptions, with limited data for edoxaban. We analyzed edoxaban dosing patterns in atrial fibrillation patients from the Global ETNA-AF program, relating patterns to baseline characteristics and 1-year clinical outcomes. The following dosing groups were compared: non-recommended 60 mg ("overdosed") vs. recommended 30 mg; non-recommended 30 mg ("underdosed") vs. recommended 60 mg. Most (22,166/26,823; 82.6%) patients received recommended doses. Non-recommended dosing was more frequent near label-specified dose-reduction thresholds. Ischemic stroke (IS; HR 0.85, 95% CI 0.50-1.47; p = 0.6) and major bleeding (MB; HR 1.47, 95% CI 0.97-2.71; p = 0.07) did not differ between recommended 60 mg and "underdosed" groups, whereas all-cause (HR 1.61, 95% CI 1.23-2.08; p = 0.0003) and cardiovascular deaths (HR 1.61, 95% CI 1.11-2.38; p = 0.01) were higher in the "underdosed" group. Compared with recommended 30 mg, the "overdosed" group had lower IS (HR 0.51, 95% CI 0.28-0.98; p = 0.04) and all-cause death (HR 0.74, 95% CI 0.55-0.98; p = 0.03) without higher MB (HR 0.74, 95% CI 0.46-1.22; p = 0.2). In conclusion: non-recommended dosing was infrequent, but more common near dose-reduction thresholds. "Underdosing" was not associated with better clinical outcomes. The "overdosed" group had lower IS and all-cause death without higher MB.

Keywords: ETNA-AF; dosing; edoxaban; non-vitamin K antagonist oral anticoagulants; real-world data; registry.

Grants and funding

This study was sponsored by Daiichi Sankyo, Inc. Editorial support was provided by Shelley Narula from inScience Communications, Springer Healthcare Ltd., UK, and was funded by Daiichi Sankyo, Inc., Basking Ridge, NJ, USA, in accordance with Good Publication Practice guidelines (https://www.ismpp.org/gpp3, accessed on 7 January 2023).