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

<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Direct oral anticoagulants are the first‐line drugs for anticoagulation therapy in nonvalvular atrial fibrillation (<jats:styled-content style="fixed-case">NVAF</jats:styled-content>). However, a real‐world, large‐scale, clinical study on edoxaban has not been performed. Our ongoing postmarketing surveillance, <jats:styled-content style="fixed-case">ETNA</jats:styled-content>‐<jats:styled-content style="fixed-case">AF</jats:styled-content>‐Japan (<jats:italic>E</jats:italic>doxaban <jats:italic>T</jats:italic>reatment in routi<jats:italic>N</jats:italic>e clinical pr<jats:italic>A</jats:italic>ctice in patients with non‐valvular <jats:italic>A</jats:italic>trial <jats:italic>F</jats:italic>ibrillation; <jats:styled-content style="fixed-case">UMIN</jats:styled-content>000017011), was designed to collect such data.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Enrollment started on 13 April 2015 and ended on 30 September 2017. Eligible patients were those diagnosed with <jats:styled-content style="fixed-case">NVAF</jats:styled-content> who were to receive edoxaban for the first time and provided written consent for study participation. Baseline patient characteristics and adverse events (<jats:styled-content style="fixed-case">AE</jats:styled-content>s) were collected.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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 (<jats:styled-content style="fixed-case">CL</jats:styled-content>cr), and <jats:styled-content style="fixed-case">CHADS</jats:styled-content><jats:sub>2</jats:sub> score were 74.2 ± 10.0 years, 60.0 ± 12.6 kg, 64.0 ± 25.6 <jats:styled-content style="fixed-case">mL</jats:styled-content>/min, and 2.2 ± 1.3, respectively. Female patients, and patients with age ≥75 years, body weight ≤60 kg, and <jats:styled-content style="fixed-case">CL</jats:styled-content>cr <30 <jats:styled-content style="fixed-case">mL</jats:styled-content>/min constituted 40.7%, 52.4%, 54.6%, and 4.7%, respectively. Patients with paroxysmal, persistent, and permanent <jats:styled-content style="fixed-case">AF</jats:styled-content> 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 <jats:styled-content style="fixed-case">AE</jats:styled-content>s occurred in 3.29%, including major bleeding in 0.29%.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>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.</jats:p></jats:sec>