TY - JOUR
T1 - Multicenter, open-label, randomized controlled trial of warfarin and edoxaban tosilate hydrate for the treatment of deep vein thrombosis in persons with severe motor intellectual disabilities
AU - Ohmori, Hiromitsu
AU - Nakamura, Mashio
AU - Kada, Akiko
AU - Saito, Akiko M.
AU - Sanayama, Yoshitami
AU - Shinagawa, Tomoe
AU - Fujita, Hiroshi
AU - Wakisaka, Akiko
AU - Maruhashi, Keiko
AU - Okumura, Akiko
AU - Takizawa, Noboru
AU - Murata, Hiroaki
AU - Inoue, Michiko
AU - Kaneko, Hideo
AU - Taniguchi, Hidekazu
AU - Kawasaki, Masayuki
AU - Sano, Nozomi
AU - Akaboshi, Shinjiro
AU - Tanuma, Naoyuki
AU - Sone, S. U.I.
AU - Kumode, Masao
AU - Takechi, Tomoki
AU - Koretsune, Yukihiro
AU - Sumimoto, R. Y.O.
AU - Miyanomae, Takeshi
N1 - Publisher Copyright:
© 2018, Kurume University School of Medicine. All rights reserved.
PY - 2018
Y1 - 2018
N2 - Sudden death in patients with severe motor and intellectual disabilities (SMID) is sometimes caused in part by pulmonary thromboembolism (PTE), and deep venous thrombosis (DVT) has drawn attention as a possible embolic source. Warfarin, which is a conventional therapeutic agent, is not easy to control appropriately, and daily management can be especially difficult in SMID patients. On the other hand, edoxaban tosilate hydrate, which has been newly approved for insurance coverage for the treatment of DVT, is not listed in the Guidelines for the Diagnosis, Treatment and Prevention of Pulmonary Thromboembolism and Deep Vein Thrombosis (DVT-PTE guidelines). The aim of this study is to evaluate the efficacy and safety of anticoagula-tion therapy (warfarin vs. edoxaban) in DVT treatment in SMID patients by means of an open-label, randomized controlled trial. The primary endpoint is the incidence of hemorrhagic events during 12 months of follow up.
AB - Sudden death in patients with severe motor and intellectual disabilities (SMID) is sometimes caused in part by pulmonary thromboembolism (PTE), and deep venous thrombosis (DVT) has drawn attention as a possible embolic source. Warfarin, which is a conventional therapeutic agent, is not easy to control appropriately, and daily management can be especially difficult in SMID patients. On the other hand, edoxaban tosilate hydrate, which has been newly approved for insurance coverage for the treatment of DVT, is not listed in the Guidelines for the Diagnosis, Treatment and Prevention of Pulmonary Thromboembolism and Deep Vein Thrombosis (DVT-PTE guidelines). The aim of this study is to evaluate the efficacy and safety of anticoagula-tion therapy (warfarin vs. edoxaban) in DVT treatment in SMID patients by means of an open-label, randomized controlled trial. The primary endpoint is the incidence of hemorrhagic events during 12 months of follow up.
KW - Deep vein thrombosis
KW - Duplex ultrasonography
KW - Edoxaban
KW - Severe motor and intellectual disabilities
KW - Warfarin
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U2 - 10.2739/kurumemedj.MS651003
DO - 10.2739/kurumemedj.MS651003
M3 - Article
C2 - 30158356
AN - SCOPUS:85051776310
SN - 0023-5679
VL - 65
SP - 11
EP - 16
JO - Kurume Medical Journal
JF - Kurume Medical Journal
IS - 1
ER -