title: 2.4 g Mesalamine (Asacol 400 mg tablet) Once Daily is as Effective as Three Times Daily in Maintenance of Remission in Ulcerative Colitis: A Randomized, Noninferiority, Multi-center Trial.
abstract: The noninferiority of pH-dependent release mesalamine (Asacol) once daily (QD) to 3 times daily (TID) administration was investigated.
  
  
  
  This was a phase 3, multicenter, randomized, double-blind, parallel-group, active-control study, with dynamic and stochastic allocation using central registration. Patients with ulcerative colitis in remission (a bloody stool score of 0, and an ulcerative colitis disease activity index of ≤2), received the study drug (Asacol 2.4 g/d) for 48 weeks. The primary efficacy endpoint of the nonrecurrence rate was assessed on the full analysis set. The noninferiority margin was 10%.
  
  
  
  Six hundred and four subjects were eligible and were allocated; 603 subjects received the study drug. The full analysis set comprised 602 subjects (QD: 301, TID: 301). Nonrecurrence rates were 88.4% in the QD and 89.6% in the TID. The difference between nonrecurrence rates was -1.3% (95% confidence interval: -6.2, 3.7), confirming noninferiority. No differences in the safety profile were observed between the two treatment groups. On post hoc analysis by integrating the QD and the TID, nonrecurrence rate with a mucosal appearance score of 0 at determination of eligibility was significantly higher than the score of 1. The mean compliance rates were 97.7% in the QD and 98.1% in the TID.
  
  
  
  QD dosing with Asacol is as effective and safe as TID for maintenance of remission in patients with ulcerative colitis. Additionally, this study indicated that maintaining a good mucosal state is the key for longer maintenance of remission.
authors.affiliation: *Department of Internal Medicine, Toho University Sakura Medical Center, Sakura, Japan;†Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan;‡Kinshukai Infusion Clinic, Osaka, Japan;§Matsushima Clinic, Yokohama, Japan;‖Ohmori Toshihide Gastro-Intestinal Clinic, Ageo, Japan;¶Toukatsu Tsujinaka Hospital, Abiko, Japan;**Yokoyama Hospital for Gastroenterological Diseases, Nagoya, Japan. T. Yokoyama is now with theYokoyama IBD Clinic, Nagoya, Japan;††Clinical Research 2, Zeria Pharmaceutical Co., Ltd., Tokyo, Japan; and‡‡Center for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University, Tokyo, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Suzuki
authors.forename: Mitsuo
authors.initials: M
authors.lastname: Iida
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Ito
authors.forename: Haruo
authors.initials: H
authors.lastname: Nishino
authors.forename: Toshihide
authors.initials: T
authors.lastname: Ohmori
authors.forename: Takehiro
authors.initials: T
authors.lastname: Arai
authors.forename: Tadashi
authors.initials: T
authors.lastname: Yokoyama
authors.forename: Takanori
authors.initials: T
authors.lastname: Okubo
authors.forename: Toshifumi
authors.initials: T
authors.lastname: Hibi
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D000074099:Equivalence Trials as Topic; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000627:therapeutic use*; D008875:Middle Aged; D010349:Patient Compliance; D011379:Prognosis; D012074:Remission Induction; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine