title: Mesalazine 4 g daily given as prolonged-release granules twice daily and four times daily is at least as effective as prolonged-release tablets four times daily in patients with ulcerative colitis.
abstract: BACKGROUND
  High doses of mesalazine usually result in an inconvenient dosage schedule and reduced compliance. The goal of this trial was to compare the effects of mesalazine 4 g daily given as prolonged-release granules in packets of 1 g with that of prolonged-release tablets of 0.5 g.
  
  
  METHODS
  Two hundred twenty-seven patients with mild-to-moderate ulcerative colitis were randomized to treatment with two packets twice daily (Gr-b.i.d.), 1 packet four times daily (Gr-q.i.d.) or 2 tablets four times daily (Ta-q.i.d.) for 8 weeks. A disease activity index (ulcerative colitis disease activity index: UC-DAI) was calculated, and the granules were defined as noninferior to the tablets if the lower limit of the 95% CI for the differences was more than -1 UC-DAI score unit.
  
  
  RESULTS
  Noninferiority of the granules compared with the tablets was demonstrated. The mean improvement in the UC-DAI in the treatment groups Gr-b.i.d., Gr-q.i.d., and Ta-q.i.d. were 3.2, 2.9, and 2.4, respectively; the proportion of complete responders in the three groups 39%, 37%, and 31%, respectively. There were no differences in side effects.
  
  
  CONCLUSIONS
  Mesalazine 4 g daily given as prolonged-release granules twice and four times daily is at least as effective as prolonged-release tablets four times daily in patients with mild to moderate ulcerative colitis. The patients preferred the twice daily dosing.
authors.affiliation: Gjøvik County Hospital, Gjøvik, Norway.
authors.forename: P G
authors.initials: PG
authors.lastname: Farup
authors.forename: T A
authors.initials: TA
authors.lastname: Hinterleitner
authors.forename: M
authors.initials: M
authors.lastname: Lukás
authors.forename: X
authors.initials: X
authors.lastname: Hébuterne
authors.forename: D
authors.initials: D
authors.lastname: Rachmilewitz
authors.forename: M
authors.initials: M
authors.lastname: Campieri
authors.forename: R
authors.initials: R
authors.lastname: Meier
authors.forename: R
authors.initials: R
authors.lastname: Keller
authors.forename: B
authors.initials: B
authors.lastname: Rathbone
authors.forename: E
authors.initials: E
authors.lastname: Oddsson
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000627:therapeutic use; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage* / Q000627:therapeutic use; D008875:Middle Aged; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D003692:Delayed-Action Preparations; D019804:Mesalamine