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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 ( E doxaban  T reatment in routi N e clinical pr A ctice in patients with non‐valvular  A trial  F ibrillation;  UMIN 000017011), 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 ( AE s) 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 ( CL cr), and  CHADS  2  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  CL cr <30  mL /min constituted 40.7%, 52.4%, 54.6%, and 4.7%, respectively. Patients with paroxysmal, persistent, and permanent  AF  constituted 46.1%, 38.7%, and 15.1%, respectively. Most patients (85.3%) received dosages according to the prescribing information, and 90.8% continued the medication for 3 months. Bleeding  AE s occurred in 3.29%, including major bleeding in 0.29%.    Conclusions  The majority (90.8%) of patients continued medication and no significant safety concerns related to edoxaban were reported during the first 3 months of treatment. Clearer safety and efficacy profiles of edoxaban await data analyses after the 2‐year follow‐up period.

journal of arrhythmia

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