title: Mesalazine granules 1.5 g once-daily maintain remission in patients with ulcerative colitis who switch from other 5-ASA formulations: a pooled analysis from two randomised controlled trials.
abstract: BACKGROUND
  Mesalazine (mesalamine) granules (MG) were shown to be effective for the maintenance of remission of ulcerative colitis (UC) in two double-blind placebo-controlled trials.
  
  
  OBJECTIVE
  To evaluate the efficacy of once-daily MG for maintenance of remission in patients with UC who switched from other 5-aminosalicylic acid (5-ASA) formulations.
  
  
  METHODS
  Data from two independent multicenter, randomised, double-blind, placebo-controlled, 6-month trials evaluating patients with UC in remission were combined for analysis of a subpopulation of patients who switched from other 5-ASA formulations to MG 1.5 g or placebo upon randomisation. The primary endpoint was the percentage of patients who remained relapse-free at Month 6 or end of treatment. Relapse was defined as a Sutherland Disease Activity Index (SDAI) rectal bleeding score ≥1 and mucosal appearance score ≥2, a UC flare or medication used to treat a UC flare.
  
  
  RESULTS
  Of the 487 patients who received 5-ASA maintenance therapy at enrolment, 322 were in the MG group and 165 were in the placebo group. The percentage of patients who remained relapse-free (based on Sutherland Disease Activity Index scores) after 6 months was significantly higher with MG than placebo (78.3% vs. 58.8%, P < 0.001). Rectal bleeding, stool frequency and the physician's rating of disease activity remained unchanged after 6 months in a higher percentage of patients using MG compared with those on placebo (P < 0.004 for each endpoint).
  
  
  CONCLUSIONS
  Mesalazine granules 1.5 g once-daily is effective for maintenance of remission in UC patients who switch from other 5-ASA formulations. ClinicalTrials.gov identifiers NCT00744016, NCT00767728.
authors.affiliation: Gastroenterology Division, Department of Medicine, University of Pennsylvania, Philadelphia, USA.
authors.forename: G R
authors.initials: GR
authors.lastname: Lichtenstein
authors.forename: S
authors.initials: S
authors.lastname: Zakko
authors.forename: G L
authors.initials: GL
authors.lastname: Gordon
authors.forename: U
authors.initials: U
authors.lastname: Murthy
authors.forename: S
authors.initials: S
authors.lastname: Sedghi
authors.forename: R
authors.initials: R
authors.lastname: Pruitt
authors.forename: K
authors.initials: K
authors.lastname: Merchant
authors.forename: E
authors.initials: E
authors.lastname: Bortey
authors.forename: W P
authors.initials: WP
authors.lastname: Forbes
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D057915:Drug Substitution; D006801:Humans; D053208:Kaplan-Meier Estimate; D019804:Mesalamine / Q000008:administration & dosage*; D008875:Middle Aged; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine