title: Therapeutic efficacy of pH-dependent release formulation of mesalazine on active ulcerative colitis resistant to time-dependent release formulation: analysis of fecal calprotectin concentration.
abstract: OBJECTIVE
  Few reports have compared the clinical efficacy of a pH-dependent release formulation of mesalazine (pH-5-ASA) with a time-dependent release formulation (time-5-ASA). We examined whether pH-5-ASA is effective for active ulcerative colitis (UC) in patients resistant to time-5-ASA.
  
  
  METHODS
  We retrospectively and prospectively analyzed the efficacy of pH-5-ASA in mildly to moderately active UC patients in whom time-5-ASA did not successfully induce or maintain remission. The clinical efficacy of pH-5-ASA was assessed by clinical activity index (CAI) before and after switching from time-5-ASA. In addition, the efficacy of pH-5-ASA on mucosal healing (MH) was evaluated in a prospective manner by measuring fecal calprotectin concentration.
  
  
  RESULTS
  Thirty patients were analyzed in a retrospective manner. CAI was significantly reduced at both 4 and 8 weeks after switching to pH-5-ASA. In the prospective study (n=14), administration of pH-5-ASA also significantly reduced CAI scores at 4 and 8 weeks in these patients who were resistant to time-5-ASA. In addition, fecal calprotectin concentration was significantly decreased along with improvement in CAI after switching to pH-5-ASA.
  
  
  CONCLUSIONS
  Our results suggest that pH-5-ASA has clinical efficacy for mildly to moderately active patients with UC in whom time-5-ASA did not successfully induce or maintain remission.
authors.affiliation: Department of Internal Medicine II, Shimane University School of Medicine, 89-1 Enya-cho, Izumo 6938501, Japan.
authors.forename: Kousaku
authors.initials: K
authors.lastname: Kawashima
authors.affiliation: Department of Internal Medicine II, Shimane University School of Medicine, 89-1 Enya-cho, Izumo 6938501, Japan.
authors.forename: Shunji
authors.initials: S
authors.lastname: Ishihara
authors.affiliation: Department of Internal Medicine II, Shimane University School of Medicine, 89-1 Enya-cho, Izumo 6938501, Japan.
authors.forename: Takafumi
authors.initials: T
authors.lastname: Yuki
authors.affiliation: Division of Internal Medicine, Matsue Seikyo Hospital, 8-8-8 Nishitsuda, Matsue 6908522, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Onishi
authors.affiliation: Division of Gastroenterology, Matsue Red Cross Hospital, 200 Horo-cho, Matsue 6908506, Japan.
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Kushiyama
authors.affiliation: Division of Gastroenterology, Shimane Prefectural Central Hospital, 4-1-1 Himebara-cho, Izumo 6938553, Japan.
authors.forename: Hirofumi
authors.identifier: 0000-0002-9105-6637
authors.initials: H
authors.lastname: Fujishiro
authors.affiliation: Division of Gastroenterology, Shimane Prefectural Central Hospital, 4-1-1 Himebara-cho, Izumo 6938553, Japan.
authors.forename: Youichi
authors.initials: Y
authors.lastname: Miyaoka
authors.affiliation: Division of Internal Medicine, Izumo City General Medical Center, 613 Nadabunn-cho, Izumo 6910003, Japan.
authors.forename: Mika
authors.initials: M
authors.lastname: Yuki
authors.affiliation: Division of Internal Medicine, Izumo City General Medical Center, 613 Nadabunn-cho, Izumo 6910003, Japan.
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Komazawa
authors.affiliation: Division of Gastroenterology, Matsue City Hospital, 32-1 Noshira-cho, Matsue 6908509, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Tanimura
authors.affiliation: Department of Internal Medicine II, Shimane University School of Medicine, 89-1 Enya-cho, Izumo 6938501, Japan.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Sonoyama
authors.affiliation: Department of Internal Medicine II, Shimane University School of Medicine, 89-1 Enya-cho, Izumo 6938501, Japan.
authors.forename: Yasumasa
authors.initials: Y
authors.lastname: Tada
authors.affiliation: Department of Internal Medicine II, Shimane University School of Medicine, 89-1 Enya-cho, Izumo 6938501, Japan.
authors.forename: Ryusaku
authors.initials: R
authors.lastname: Kusunoki
authors.affiliation: Department of Internal Medicine II, Shimane University School of Medicine, 89-1 Enya-cho, Izumo 6938501, Japan.
authors.forename: Akihiko
authors.identifier: 0000-0001-6451-8413
authors.initials: A
authors.lastname: Oka
authors.affiliation: Department of Internal Medicine II, Shimane University School of Medicine, 89-1 Enya-cho, Izumo 6938501, Japan.
authors.forename: Nobuhiko
authors.initials: N
authors.lastname: Fukuba
authors.affiliation: Department of Internal Medicine II, Shimane University School of Medicine, 89-1 Enya-cho, Izumo 6938501, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Oshima
authors.affiliation: Division of Cancer Center, Shimane University Hospital, 89-1 Enya-cho, Izumo 6938501, Japan.
authors.forename: Ichiro
authors.initials: I
authors.lastname: Moriyama
authors.affiliation: Department of Internal Medicine II, Shimane University School of Medicine, 89-1 Enya-cho, Izumo 6938501, Japan.
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Kinoshita
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D002626:Chemistry, Pharmaceutical; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000473:pathology; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D005243:Feces; D005260:Female; D006801:Humans; D006863:Hydrogen-Ion Concentration; D039841:Leukocyte L1 Antigen Complex / Q000302:isolation & purification / Q000378:metabolism*; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage* / Q000378:metabolism; D008875:Middle Aged
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D003692:Delayed-Action Preparations; D039841:Leukocyte L1 Antigen Complex; D019804:Mesalamine