PMID- 25717286
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20150226
LR  - 20220409
IS  - 1477-9560 (Print)
IS  - 1477-9560 (Electronic)
IS  - 1477-9560 (Linking)
VI  - 13
DP  - 2015
TI  - Oral rivaroxaban for Japanese patients with symptomatic venous thromboembolism - 
      the J-EINSTEIN DVT and PE program.
PG  - 2
LID - 10.1186/s12959-015-0035-3 [doi]
LID - 2
AB  - BACKGROUND: The global EINSTEIN DVT and PE studies compared rivaroxaban (15 mg 
      twice daily for 3 weeks followed by 20 mg once daily) with enoxaparin/vitamin K 
      antagonist therapy and demonstrated non-inferiority for efficacy and superiority 
      for major bleeding. Owing to differences in targeted anticoagulant intensities in 
      Japan, Japanese patients were not enrolled into the global studies. Instead, a 
      separate study of deep vein thrombosis (DVT) and/or pulmonary embolism (PE) in 
      Japanese patients was conducted, which compared the Japanese standard of care 
      with a reduced dose of rivaroxaban. METHODS: We conducted an open-label, 
      randomized trial that compared 3, 6, or 12 months of oral rivaroxaban alone (10 
      mg twice daily or 15 mg twice daily for 3 weeks followed by 15 mg once daily) 
      with activated partial thromboplastin time-adjusted intravenous unfractionated 
      heparin (UFH) followed by warfarin (target international normalized ratio 2.0; 
      range 1.5-2.5) in patients with acute, objectively confirmed symptomatic DVT 
      and/or PE. Patients were assessed for the occurrence of symptomatic recurrent 
      venous thromboembolic events or asymptomatic deterioration and bleeding. RESULTS: 
      Eighty-one patients were assigned to rivaroxaban and 19 patients to UFH/warfarin. 
      Three patients were excluded because of serious non-compliance issues. The 
      composite of symptomatic venous thromboembolic events or asymptomatic 
      deterioration occurred in 1 (1.4%) rivaroxaban patient and in 1 (5.3%) 
      UFH/warfarin patient (absolute risk difference, 3.9% [95% confidence interval, 
      -3.4-23.8]). No major bleeding occurred during study treatment. Clinically 
      relevant non-major bleeding occurred in 6 (7.8%) patients in the rivaroxaban 
      group and 1 (5.3%) patient in the UFH/warfarin group. CONCLUSIONS: The findings 
      of this study in Japanese patients with acute DVT and/or PE suggest a similar 
      efficacy and safety profile with rivaroxaban and control treatment, consistent 
      with that of the worldwide EINSTEIN DVT and PE program. TRIAL REGISTRATION: 
      Clinicaltrials.gov: NCT01516840 and NCT01516814.
FAU - Yamada, Norikazu
AU  - Yamada N
AD  - Department of Cardiology and Nephrology, Mie University Graduate School of 
      Medicine, Mie, 514-8507 Japan.
FAU - Hirayama, Atsushi
AU  - Hirayama A
AD  - Division of Cardiology, Department of Medicine, Nihon University School of 
      Medicine, Tokyo, Japan.
FAU - Maeda, Hideaki
AU  - Maeda H
AD  - Division of Cardiovascular, Respiratory and general surgery, Nihon University 
      School of Medicine, Tokyo, Japan.
FAU - Sakagami, Satoru
AU  - Sakagami S
AD  - Department of Cardiology, National Hospital Organization, Kanazawa Medical 
      Center, Kanazawa, Japan.
FAU - Shikata, Hiroo
AU  - Shikata H
AD  - Department of Cardiovascular Surgery, Kanazawa Medical University, Ishikawa, 
      Japan.
FAU - Prins, Martin H
AU  - Prins MH
AD  - Maastricht University Medical Center, Maastricht, The Netherlands.
FAU - Lensing, Anthonie Wa
AU  - Lensing AW
AD  - Bayer HealthCare Pharmaceuticals, Wuppertal, Germany.
FAU - Kato, Masaharu
AU  - Kato M
AD  - Bayer Yakuhin Ltd, Osaka, Japan.
FAU - Onuma, Junichi
AU  - Onuma J
AD  - Bayer Yakuhin Ltd, Osaka, Japan.
FAU - Miyamoto, Yuki
AU  - Miyamoto Y
AD  - Bayer Yakuhin Ltd, Osaka, Japan.
FAU - Iekushi, Kazuma
AU  - Iekushi K
AD  - Bayer Yakuhin Ltd, Osaka, Japan.
FAU - Kajikawa, Mariko
AU  - Kajikawa M
AD  - Bayer Yakuhin Ltd, Osaka, Japan.
LA  - eng
SI  - ClinicalTrials.gov/NCT01516840
SI  - ClinicalTrials.gov/NCT01516814
PT  - Journal Article
DEP - 20150117
PL  - England
TA  - Thromb J
JT  - Thrombosis journal
JID - 101170542
EIN - Thromb J. 2016;14:11. PMID: 27222638
PMC - PMC4339301
OTO - NOTNLM
OT  - Deep vein thrombosis
OT  - Japan
OT  - Pulmonary embolism
OT  - Randomized trial
OT  - Rivaroxaban
OT  - Unfractionated heparin
OT  - Venous thromboembolism
OT  - Warfarin
EDAT- 2015/02/27 06:00
MHDA- 2015/02/27 06:01
PMCR- 2015/01/17
CRDT- 2015/02/27 06:00
PHST- 2014/10/23 00:00 [received]
PHST- 2015/01/04 00:00 [accepted]
PHST- 2015/02/27 06:00 [entrez]
PHST- 2015/02/27 06:00 [pubmed]
PHST- 2015/02/27 06:01 [medline]
PHST- 2015/01/17 00:00 [pmc-release]
AID - 35 [pii]
AID - 10.1186/s12959-015-0035-3 [doi]
PST - epublish
SO  - Thromb J. 2015 Jan 17;13:2. doi: 10.1186/s12959-015-0035-3. eCollection 2015.