Dataset Information

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

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.

SUBMITTER: Chao TF

PROVIDER: S-EPMC10003604 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Chao Tze-Fan TF Unverdorben Martin M Kirchhof Paulus P Koretsune Yukihiro Y Yamashita Takeshi T Crozier Robert A RA Pecen Ladislav L Chen Cathy C Borrow Amanda P AP De Caterina Raffaele R

Journal of clinical medicine 20230227 5

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 ...[more]

PMID: 36902656

Similar Datasets

Project description:Abstract Background Direct oral anticoagulants (DOACs) are the recommended first‐line therapy for ischemic stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). However, the safety and effectiveness of edoxaban for this indication requires monitoring over the long term in real‐world settings. Methods ETNA‐AF‐Japan (trial no. UMIN000017011) was a prospective, multicenter observational study (part of postmarketing surveillance in Japan). NVAF patients due to receive edoxaban to prevent ischemic stroke were enrolled between 13 April 2015 and 30 September 2017. Results A total of 11 569 patients were enrolled. For the 11 111 patients (female, 40.6%) whose data comprised the safety analysis set, age, body weight, creatinine clearance (CLcr), and CHADS2 score were 74.2 ± 10.0 years, 60.0 ± 12.7 kg, 63.9 ± 25.8 mL/min, and 2.2 ± 1.3, respectively (mean ± SD). The majority (86.3%) received edoxaban in accordance with package insert information. The mean duration of treatment was 561.9 ± 261.2 days. The annual incidence (95% confidence interval) of all bleeding events and major bleeding events was 5.60% (5.25%–5.98%) and 1.02% (0.88%–1.18%), respectively. The annual incidence of ischemic stroke (excluding transient ischemic attack, TIA) or systemic embolism was 1.08% (0.93%–1.25%). Multivariate analysis showed low body weight, low CLcr, history of gastrointestinal bleeding, anemia, and use of an antiplatelet agent to be associated with major bleeding, and history of ischemic stroke or TIA, vascular disease, and antiplatelet agent use to be associated with ischemic stroke (excluding TIA) or systemic embolism. Conclusions These results provide real‐world evidence for the long‐term good safety and effectiveness profile of edoxaban in Japanese NVAF patients under clinical practice. This prospective, multicenter observational study was carried out to evaluate the safety and effectiveness of edoxaban as first‐line therapy to prevent ischemic stroke in Japanese patients with nonvalvular atrial fibrillation (NVAF). Annual incidence (95% confidence interval) of all bleeding events, major bleeding events, and ischemic stroke (excluding transient ischemic attack, TIA) or systemic embolism was 5.60% (5.25%–5.98%), 1.02% (0.88%–1.18%), and 1.08% (0.93%–1.25%), respectively (safety analysis set, 11 111; effectiveness analysis set, 11 063; mean duration of treatment, 561.9 ± 261.2 days). These results add to the evidence for the long‐term good safety and effectiveness profile of edoxaban in Japanese patients with NVAF in a real‐world clinical setting.

Dataset Information

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

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets