Hiromitsu Ohmori1,2, Akiko Kada2, Mashio Nakamura3, Akiko M Saito3, Yoshitami Sanayama4, Tomoe Shinagawa5, Hiroshi Fujita5, Akiko Wakisaka6, Keiko Maruhashi6, Akiko Mizukami7, Noboru Takizawa7, Hiroaki Murata8, Michiko Inoue9, Hideo Kaneko10, Hidekazu Taniguchi11, Nozomi Sano12, Naoyuki Tanuma13, Masao Kumode14, Tomoki Takechi15, Yukihiro Koretsune16, Ryo Sumimoto17, Takeshi Miyanomae18. 1. Department of Pediatrics, National Hospital Organization Yanai Medical Center, Yanai, Yamaguchi, Japan. 2. Clinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Aichi, Japan. 3. Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, Tsu, Mie, Japan. 4. Department of Pediatrics, National Hospital Organization Shimoshizu Hospital, Yotsukaido, Chiba, Japan. 5. Department of Pediatrics, National Hospital Organization Aomori Hospital, Aomori, Aomori, Japan. 6. Department of Pediatrics, National Hospital Organization Iou Hospital, Kanazawa, Ishikawa, Japan. 7. Department of Pediatrics, National Hospital Organization Toyama Hospital, Toyama, Toyama, Japan. 8. Department of Pediatrics, National Hospital Organization Mie Hospital, Tsu, Mie, Japan. 9. Department of Pediatrics, National Hospital Organization Minami-Okayama Medical Center, Tsukubo, Okayama, Japan. 10. Department of Clinical Research, National Hospital Organization Nagara Medical Center, Gifu, Gifu, Japan. 11. Department of Pediatric Neurosurgery, National Hospital Organization Shikoku Medical Center for Children and Adults, Zentsuji, Kagawa, Japan. 12. Department of Pediatrics, National Hospital Organization Minami-Kyushu Hospital, Aira, Kagoshima, Japan. 13. Department of Pediatrics, Tokyo Metropolitan Fuchu Medical Center for the Disabled, Fuchu, Tokyo, Japan. 14. Department of Pediatrics, Biwako Gakuen Kusatsu Medical and Welfare Center, Kusatsu, Shiga, Japan. 15. Department of Pediatrics, National Hospital Organization Kochi Hospital, Kochi, Kochi, Japan. 16. National Hospital Organization Osaka National Hospital, Osaka, Osaka, Japan. 17. National Hospital Organization Yanai Medical Center, Yanai, Yamaguchi, Japan. 18. National Hospital Organization Minami Kyoto Hospital, Joyo, Kyoto, Japan.
Abstract
Objective: Patients with severe motor and intellectual disabilities (SMID) often develop complications, including paralysis of the extremities due to abnormal muscular tonicity. Furthermore, the incidence of sudden death, which may be caused by pulmonary thromboembolism (PTE), is approximately 4.2%. Deep vein thrombosis (DVT) is attracting attention as an embolic source. In this study, DVT was confirmed in SMID patients by lower extremity venous ultrasound. The oral anticoagulant, warfarin, and novel oral anticoagulant, edoxaban tosilate hydrate, were administered, and their efficacies and safeties were evaluated. Materials and Methods:DVT patients were randomly allocated to warfarin and edoxaban groups. The frequency of hemorrhagic events and incidence of adverse events were investigated to evaluate efficacy and safety. Results:DVT was detected in 14 (8.4%) out of 167 patients. Four (0.067/person-month) hemorrhagic events occurred in the warfarin group from subcutaneous hemorrhage due to bruises caused by postural changes. Three (0.042/person-month) events occurred in the edoxaban group due to nasal hemorrhage caused by tracheal aspiration. There was no significant difference (p=0.5383) between groups. Conclusion: No significant differences were observed in hemorrhagic events between SMID patients with DVT treated withwarfarin and edoxaban.
RCT Entities:
Objective: Patients with severe motor and intellectual disabilities (SMID) often develop complications, including paralysis of the extremities due to abnormal muscular tonicity. Furthermore, the incidence of sudden death, which may be caused by pulmonary thromboembolism (PTE), is approximately 4.2%. Deep vein thrombosis (DVT) is attracting attention as an embolic source. In this study, DVT was confirmed in SMID patients by lower extremity venous ultrasound. The oral anticoagulant, warfarin, and novel oral anticoagulant, edoxaban tosilate hydrate, were administered, and their efficacies and safeties were evaluated. Materials and Methods:DVTpatients were randomly allocated to warfarin and edoxaban groups. The frequency of hemorrhagic events and incidence of adverse events were investigated to evaluate efficacy and safety. Results:DVT was detected in 14 (8.4%) out of 167 patients. Four (0.067/person-month) hemorrhagic events occurred in the warfarin group from subcutaneous hemorrhage due to bruises caused by postural changes. Three (0.042/person-month) events occurred in the edoxaban group due to nasal hemorrhage caused by tracheal aspiration. There was no significant difference (p=0.5383) between groups. Conclusion:No significant differences were observed in hemorrhagic events between SMID patients with DVT treated with warfarin and edoxaban.
Authors: Harry R Büller; Hervé Décousus; Michael A Grosso; Michele Mercuri; Saskia Middeldorp; Martin H Prins; Gary E Raskob; Sebastian M Schellong; Lee Schwocho; Annelise Segers; Minggao Shi; Peter Verhamme; Phil Wells Journal: N Engl J Med Date: 2013-08-31 Impact factor: 91.245
Authors: M Nakamura; Y Q Wang; C Wang; D Oh; W-H Yin; T Kimura; K Miyazaki; K Abe; M Mercuri; L H Lee; A Segers; H Büller Journal: J Thromb Haemost Date: 2015-08-27 Impact factor: 5.824
Authors: Robert P Giugliano; Christian T Ruff; Eugene Braunwald; Sabina A Murphy; Stephen D Wiviott; Jonathan L Halperin; Albert L Waldo; Michael D Ezekowitz; Jeffrey I Weitz; Jindřich Špinar; Witold Ruzyllo; Mikhail Ruda; Yukihiro Koretsune; Joshua Betcher; Minggao Shi; Laura T Grip; Shirali P Patel; Indravadan Patel; James J Hanyok; Michele Mercuri; Elliott M Antman Journal: N Engl J Med Date: 2013-11-19 Impact factor: 91.245