Tze-Fan Chao1, Keun-Sik Hong2, Byung-Chul Lee3, Raffaele De Caterina4, Paulus Kirchhof5, Paul-Egbert Reimitz6, Cathy Chen7, Martin Unverdorben7, Chun-Chieh Wang8. 1. Division of Cardiology, Taipei Veterans General Hospital and National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC. 2. Department of Neurology, Inje University Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea. 3. Department of Neurology, Hallym University Sacred Heart Hospital, Hallym Neurological Institute, Hallym University College of Medicine, Anyang, Korea. 4. Division of Cardiology, Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, Pisa University Hospital and University of Pisa, Pisa, Italy. 5. Department of Cardiology, University Heart and Vascular Centre Hamburg, Hamburg, Germany and Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, UK. 6. Biostatistics and Data Operations, Daiichi Sankyo Europe, GmbH, Munich, Germany. 7. Medical Affairs, Daiichi Sankyo, Inc., Basking Ridge, NJ, USA. 8. Division of Cardiology, Department of Internal Medicine, Chang Gung University and Chang Gung Memorial Hospital, Taoyuan, Taiwan, ROC.
Abstract
BACKGROUND: Direct oral anticoagulants (DOACs) have replaced vitamin K antagonists as the standard of care for stroke prevention in patients with atrial fibrillation (AF). However, DOAC prescriptions at dosages that do not adhere to labeling are common in daily practice. This analysis from the observational Global Edoxaban Treatment in routiNe clinical prActice (ETNA)-AF program focuses on edoxaban-treated patients from South Korea and Taiwan to identify patient baseline characteristics that may be associated with non-recommended dosing. METHODS: We report baseline data from ETNA-AF, including patient demographics, clinical characteristics, and bleeding/stroke history of patients receiving recommended or non-recommended edoxaban dosing. RESULTS: A total of 2677 patients were enrolled. Among 1543 patients who did not meet dose-reduction criteria, 1033 (66.9%) were prescribed the recommended 60-mg dose, and 510 (33.1%) were prescribed the non-recommended 30-mg dose. Among 1134 patients meeting ≥1 of the dose-reduction criteria, 863 (76.1%) were prescribed the recommended 30-mg dose; 271 (23.9%) were prescribed the nonrecommended 60-mg dose. Compared with the recommended 60-mg group, the nonrecommended 30-mg group had a higher proportion of patients aged ≥75 years, higher stroke and bleeding risks, and a history of major bleeding. The non-recommended 60-mg group had a lower proportion of patients aged ≥75 years, a higher history of stroke, and lower history of bleeding compared with the recommended 30-mg group. CONCLUSION: The baseline data from ETNA-AF indicate that physicians take patient clinical characteristics (e.g., bleeding risks) into consideration when deviating from the dosing recommendation per label.
BACKGROUND: Direct oral anticoagulants (DOACs) have replaced vitamin K antagonists as the standard of care for stroke prevention in patients with atrial fibrillation (AF). However, DOAC prescriptions at dosages that do not adhere to labeling are common in daily practice. This analysis from the observational Global Edoxaban Treatment in routiNe clinical prActice (ETNA)-AF program focuses on edoxaban-treated patients from South Korea and Taiwan to identify patient baseline characteristics that may be associated with non-recommended dosing. METHODS: We report baseline data from ETNA-AF, including patient demographics, clinical characteristics, and bleeding/stroke history of patients receiving recommended or non-recommended edoxaban dosing. RESULTS: A total of 2677 patients were enrolled. Among 1543 patients who did not meet dose-reduction criteria, 1033 (66.9%) were prescribed the recommended 60-mg dose, and 510 (33.1%) were prescribed the non-recommended 30-mg dose. Among 1134 patients meeting ≥1 of the dose-reduction criteria, 863 (76.1%) were prescribed the recommended 30-mg dose; 271 (23.9%) were prescribed the nonrecommended 60-mg dose. Compared with the recommended 60-mg group, the nonrecommended 30-mg group had a higher proportion of patients aged ≥75 years, higher stroke and bleeding risks, and a history of major bleeding. The non-recommended 60-mg group had a lower proportion of patients aged ≥75 years, a higher history of stroke, and lower history of bleeding compared with the recommended 30-mg group. CONCLUSION: The baseline data from ETNA-AF indicate that physicians take patient clinical characteristics (e.g., bleeding risks) into consideration when deviating from the dosing recommendation per label.