PMID- 30805052
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231005
IS  - 1880-4276 (Print)
IS  - 1883-2148 (Electronic)
IS  - 1880-4276 (Linking)
VI  - 35
IP  - 1
DP  - 2019 Feb
TI  - Postmarketing surveillance on clinical use of edoxaban in patients with 
      nonvalvular atrial fibrillation (ETNA-AF-Japan): Three-month interim analysis 
      results.
PG  - 121-129
LID - 10.1002/joa3.12149 [doi]
AB  - 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 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 CLcr <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 AEs 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.
FAU - Yamashita, Takeshi
AU  - Yamashita T
AUID- ORCID: 0000-0002-2544-8464
AD  - The Cardiovascular Institute Tokyo Japan.
FAU - Koretsune, Yukihiro
AU  - Koretsune Y
AD  - National Hospital Organization Osaka National Hospital Osaka Japan.
FAU - Ishikawa, Mayumi
AU  - Ishikawa M
AUID- ORCID: 0000-0002-6154-3485
AD  - Post Marketing Study Department Daiichi Sankyo Co. Ltd. Tokyo Japan.
FAU - Shiosakai, Kazuhito
AU  - Shiosakai K
AD  - Biostatistics & Data Management Department Daiichi Sankyo Co. Ltd. Tokyo Japan.
FAU - Kogure, Seiji
AU  - Kogure S
AD  - Post Marketing Study Department Daiichi Sankyo Co. Ltd. Tokyo Japan.
LA  - eng
PT  - Journal Article
DEP - 20181226
PL  - Japan
TA  - J Arrhythm
JT  - Journal of arrhythmia
JID - 101263026
PMC - PMC6373660
OTO - NOTNLM
OT  - anticoagulant
OT  - edoxaban
OT  - elderly patient
OT  - nonvalvular atrial fibrillation
OT  - observational study
EDAT- 2019/02/26 06:00
MHDA- 2019/02/26 06:01
PMCR- 2018/12/26
CRDT- 2019/02/27 06:00
PHST- 2018/09/27 00:00 [received]
PHST- 2018/11/20 00:00 [revised]
PHST- 2018/11/27 00:00 [accepted]
PHST- 2019/02/27 06:00 [entrez]
PHST- 2019/02/26 06:00 [pubmed]
PHST- 2019/02/26 06:01 [medline]
PHST- 2018/12/26 00:00 [pmc-release]
AID - JOA312149 [pii]
AID - 10.1002/joa3.12149 [doi]
PST - epublish
SO  - J Arrhythm. 2018 Dec 26;35(1):121-129. doi: 10.1002/joa3.12149. eCollection 2019 
      Feb.