title: A randomized trial comparing 4.8 vs. 2.4 g/day of oral mesalazine for maintenance of remission in ulcerative colitis.
abstract: BACKGROUND
  Mesalazine is used as maintenance therapy in ulcerative colitis but the optimal dosage is still controversial.
  
  
  OBJECTIVE
  To compare the remission-maintenance efficacy and tolerability of two daily doses of oral mesalazine (4.8 g and 2.4 g) in patients with ulcerative colitis with frequent relapses in a randomized controlled trial.
  
  
  METHODS
  112 ulcerative colitis patients in remission were enrolled and randomly allocated to treatment for 1 year with oral mesalazine at a daily dose of 4.8 g (n=56, Group A) or 2.4 g (n=56, Group B).
  
  
  RESULTS
  At the end of the 12 months, intention to treat analysis revealed persistent remission in 42 (75%) in Group A and 36 (64.2%) in Group B (p=0.3). The higher daily dose (4.8 g) proved to be significantly more effective for maintaining remission in patients under 40 years of age (90.5% Group A vs. 50% Group B; Fisher's exact test, p=0.0095) and in those with extensive disease (90.9% Group A vs. 46.7% Group B; Fisher's exact test, p=0.0064).
  
  
  CONCLUSIONS
  In ulcerative colitis patients younger than 40 years and/or with extensive disease, a daily dose of 4.8 g oral mesalazine results in increased rates and duration of remission compared to 2.4 g.
authors.affiliation: IBD Unit, Division of Gastroenterology and Digestive Endoscopy, Sandro Pertini Hospital, Rome, Italy. Electronic address: roberta.pica@aslromab.it.
authors.forename: Roberta
authors.initials: R
authors.lastname: Pica
authors.affiliation: Department of Internal Medicine and Medical Specialties, Gastroenterology Unit, "Sapienza", University of Rome, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Cassieri
authors.affiliation: IBD Unit, Division of Gastroenterology and Digestive Endoscopy, Sandro Pertini Hospital, Rome, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Cocco
authors.affiliation: IBD Unit, Division of Gastroenterology and Digestive Endoscopy, Sandro Pertini Hospital, Rome, Italy.
authors.forename: Maddalena
authors.initials: M
authors.lastname: Zippi
authors.affiliation: Department of Internal Medicine and Medical Specialties, Gastroenterology Unit, "Sapienza", University of Rome, Italy.
authors.forename: Adriana
authors.initials: A
authors.lastname: Marcheggiano
authors.affiliation: IBD Unit, Division of Gastroenterology and Digestive Endoscopy, Sandro Pertini Hospital, Rome, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: De Nitto
authors.affiliation: Department of Internal Medicine and Medical Specialties, Gastroenterology Unit, "Sapienza", University of Rome, Italy.
authors.forename: Eleonora Veronica
authors.initials: EV
authors.lastname: Avallone
authors.affiliation: Department of Internal Medicine and Medical Specialties, Gastroenterology Unit, "Sapienza", University of Rome, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Crispino
authors.affiliation: IBD Unit, Division of Gastroenterology and Digestive Endoscopy, Sandro Pertini Hospital, Rome, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Occhigrossi
authors.affiliation: Department of Internal Medicine and Medical Specialties, Gastroenterology Unit, "Sapienza", University of Rome, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Paoluzi
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D001706:Biopsy; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000473:pathology; D003113:Colonoscopy; D005260:Female; D006801:Humans; D060046:Maintenance Chemotherapy / Q000379:methods*; D008297:Male; D055118:Medication Adherence; D019804:Mesalamine / Q000008:administration & dosage*; D008875:Middle Aged; D012008:Recurrence; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine
keywords: Daily dosage; Maintenance of remission; Mesalazine; Ulcerative colitis