title: Safety and Tolerability of Nafamostat Mesilate and Heparin as Anticoagulants in Leukocytapheresis for Ulcerative Colitis: Post Hoc Analysis of a Large-Scale, Prospective, Observational Study.
abstract: Nafamostat mesilate is the first anticoagulant of choice for leukocytapheresis (LCAP) with a Cellsorba E column for treating ulcerative colitis (UC). However, because of complications, mainly due to allergy to nafamostat mesilate, heparin may be used as a substitute. To evaluate the safety and tolerability of nafamostat mesilate and heparin as anticoagulants in LCAP for UC, we conducted post hoc analysis of data from a large-scale, prospective, observational study of LCAP, which was conducted at 116 medical facilities in Japan between May 2010 and December 2012. Of 832 patients included in this analysis, nafamostat mesilate and heparin were used in 676 (81.3%) and 113 (13.6%), respectively. There were no significant differences in the incidence of adverse reactions (8.6% vs. 7.1%) and intrafilter pressure increases (12.7% vs. 16.8%) between the nafamostat mesilate and heparin groups. Adverse reactions of hemorrhage or blood pressure decreases associated with heparin use were not observed. There were no significant differences in rates of clinical remission (69.1% vs. 68.1%) and mucosal healing (62.9% vs. 63.6%) between the nafamostat mesilate and heparin groups. Thus, the safety and tolerability were comparable in the nafamostat mesilate and heparin groups, indicating that both nafamostat mesilate and heparin can be well tolerated as anticoagulants in LCAP for UC.
authors.affiliation: Dojima General & Gastroenterology Clinic, Osaka, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Sawada
authors.affiliation: Dojima General & Gastroenterology Clinic, Osaka, Japan.
authors.forename: Maiko
authors.initials: M
authors.lastname: Ohdo
authors.affiliation: Scientific and Technical Affairs Department, Japan Operation Division, Blood Purification Business Unit, Asahi Kasei Medical Co. Ltd., Tokyo, Japan.
authors.forename: Tomoko
authors.initials: T
authors.lastname: Ino
authors.affiliation: Scientific and Technical Affairs Department, Japan Operation Division, Blood Purification Business Unit, Asahi Kasei Medical Co. Ltd., Tokyo, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Nakamura
authors.affiliation: Scientific and Technical Affairs Department, Japan Operation Division, Blood Purification Business Unit, Asahi Kasei Medical Co. Ltd., Tokyo, Japan.
authors.forename: Toyoko
authors.initials: T
authors.lastname: Numata
authors.affiliation: Scientific and Technical Affairs Department, Japan Operation Division, Blood Purification Business Unit, Asahi Kasei Medical Co. Ltd., Tokyo, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Shibata
authors.affiliation: Scientific and Technical Affairs Department, Japan Operation Division, Blood Purification Business Unit, Asahi Kasei Medical Co. Ltd., Tokyo, Japan.
authors.forename: Jun-ichi
authors.initials: J
authors.lastname: Sakou
authors.affiliation: Scientific and Technical Affairs Department, Japan Operation Division, Blood Purification Business Unit, Asahi Kasei Medical Co. Ltd., Tokyo, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Kusada
authors.affiliation: Center for Advanced IBD Research and Treatment, Kitasato University, Kitasato Institute Hospital, Tokyo, Japan.
authors.forename: Toshifumi
authors.initials: T
authors.lastname: Hibi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D001550:Benzamidines; D002648:Child; D003093:Colitis, Ulcerative / Q000628:therapy*; D005260:Female; D006146:Guanidines / Q000008:administration & dosage* / Q000009:adverse effects; D006493:Heparin / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007937:Leukapheresis / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012074:Remission Induction / Q000379:methods; D055815:Young Adult
chemical_list: D000925:Anticoagulants; D001550:Benzamidines; D006146:Guanidines; D006493:Heparin; C032855:nafamostat
keywords: Anticoagulant; Heparin; Leukocytapheresis; Nafamostat mesilate; Ulcerative colitis