Division of Cardiology, Taipei Veterans General Hospital and National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC.
Department of Neurology, Inje University Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea.
J Chin Med Assoc. 2021 May 1;84(5):485-490. doi: 10.1097/JCMA.0000000000000516.
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.
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.
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.
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.
直接口服抗凝剂（DOAC）已取代维生素 K 拮抗剂，成为房颤（AF）患者预防中风的标准治疗方法。然而，在日常实践中，DOAC 处方剂量不遵循标签规定的情况很常见。这项来自观察性全球依度沙班治疗常规临床实践（ETNA）-AF 项目的分析，重点关注韩国和中国台湾接受依度沙班治疗的患者，以确定可能与不推荐剂量相关的患者基线特征。
我们报告了 ETNA-AF 的基线数据，包括患者的人口统计学、临床特征以及接受推荐或不推荐依度沙班剂量的患者的出血/中风史。
共纳入 2677 例患者。在未符合剂量减少标准的 1543 例患者中，1033 例（66.9%）被处方推荐剂量 60mg，510 例（33.1%）被处方非推荐剂量 30mg。在符合≥1 项剂量减少标准的 1134 例患者中，863 例（76.1%）被处方推荐剂量 30mg；271 例（23.9%）被处方非推荐剂量 60mg。与推荐的 60mg 组相比，非推荐的 30mg 组中年龄≥75 岁的患者比例更高，中风和出血风险更高，且有大出血病史。与推荐的 30mg 组相比，非推荐的 60mg 组年龄≥75 岁的患者比例较低，中风病史较高，出血病史较低。
ETNA-AF 的基线数据表明，医生在开处方时会考虑患者的临床特征（如出血风险），从而偏离标签推荐剂量。
