Postmarketing surveillance on clinical use of edoxaban in patients with nonvalvular atrial fibrillation (ETNA‐AF‐Japan): Three‐month interim analysis results

Background Direct oral anticoagulants are the first‐line drugs for anticoagulation therapy in nonvalvular atrial fibrillation (NVAF). However, a real‐world, large‐scale, clinical study on edoxaban has not been performed. Our ongoing postmarketing surveillance, ETNA‐AF‐Japan (Edoxaban Treatment in ro...

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Bibliographic Details
Published in:Journal of arrhythmia 2019-02, Vol.35 (1), p.121-129
Main Authors: Yamashita, Takeshi, Koretsune, Yukihiro, Ishikawa, Mayumi, Shiosakai, Kazuhito, Kogure, Seiji
Format: Article
Language:English
Subjects:
Age
anticoagulant
Anticoagulants
Anticoagulants (Medicine)
Atrial fibrillation
Bone surgery
Cardiac arrhythmia
Care and treatment
Clinical medicine
Diabetes
Drug dosages
edoxaban
elderly patient
Embolisms
Health aspects
Heart attacks
Heart failure
Hypertension
Information management
nonvalvular atrial fibrillation
Observational studies
observational study
Original
Patients
Prevention
Registration
Stroke
Studies
Substance abuse treatment
Surveillance
Thromboembolism
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Summary:Background Direct oral anticoagulants are the first‐line drugs for anticoagulation therapy in nonvalvular atrial fibrillation (NVAF). However, a real‐world, large‐scale, clinical study on edoxaban has not been performed. Our ongoing postmarketing surveillance, ETNA‐AF‐Japan (Edoxaban Treatment in routiNe clinical prActice in patients with non‐valvular Atrial Fibrillation; UMIN000017011), was designed to collect such data. Methods Enrollment started on 13 April 2015 and ended on 30 September 2017. Eligible patients were those diagnosed with NVAF who were to receive edoxaban for the first time and provided written consent for study participation. Baseline patient characteristics and adverse events (AEs) were collected. Results A total of 11 569 patients were enrolled. Data for 8157 patients in the first 3 months were analyzed. Mean age, body weight, creatinine clearance (CLcr), and CHADS2 score were 74.2 ± 10.0 years, 60.0 ± 12.6 kg, 64.0 ± 25.6 mL/min, and 2.2 ± 1.3, respectively. Female patients, and patients with age ≥75 years, body weight ≤60 kg, and CLcr
ISSN:1880-4276
1883-2148
DOI:10.1002/joa3.12149