title: Once-daily Mesalamine Formulation for Maintenance of Remission in Ulcerative Colitis: A Randomized, Placebo-controlled Clinical Trial.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of mesalamine granules 1.5 g once daily for maintenance of ulcerative colitis (UC) remission.
  
  
  BACKGROUND
  Mesalamine is a first-line treatment for induction and maintenance of UC remission.
  
  
  METHODS
  A phase 3, randomized, double-blind, placebo-controlled trial of patients with a history of mild to moderate UC, currently in remission, who received mesalamine granules once daily for 6 months. The primary efficacy endpoint was percentage of patients maintaining UC remission at 6 months.
  
  
  RESULTS
  A significantly greater percentage of patients receiving mesalamine granules versus placebo were in remission at 6 months (79.9% vs. 66.7%; P=0.03). A greater percentage of patients receiving mesalamine granules maintained a revised Sutherland Disease Activity Index (SDAI)≤2 with no individual component of revised SDAI>1 and rectal bleeding=0 at 6 months (72.0% vs. 58.1%; P=0.04). No significant differences between groups were observed for change from baseline to 6 months for total SDAI score or its components (ie, stool frequency, rectal bleeding, mucosal appearance, physician's rating of disease). Mesalamine granules treatment resulted in a significantly longer remission duration versus placebo (P=0.02) and decreased patients' risk of relapse by 43% (hazard ratio=0.57; 95% confidence interval, 0.35-0.93; P=0.02). Mesalamine granules were well tolerated, and adverse events related to hepatic, renal, and pancreatic function-potential concerns with long-term treatment-occurred at a rate similar to placebo.
  
  
  CONCLUSIONS
  Once-daily mesalamine granules are efficacious and safe for the maintenance of UC remission.
authors.affiliation: *Center for Digestive and Liver Diseases Inc., Mexico, MO†Connecticut Gastroenterology Institute, Bristol, CT‡Syracuse VA Medical Center, Syracuse, NY§Gastroenterology Associates of Central Georgia LLC, Macon, GA∥Nashville Medical Research Institute and The Maria Nathanson Center at Saint Thomas Hospital, Nashville, TN¶Salix, a Division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ#Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, PA.
authors.forename: Glenn L
authors.initials: GL
authors.lastname: Gordon
authors.forename: Salam
authors.initials: S
authors.lastname: Zakko
authors.forename: Uma
authors.initials: U
authors.lastname: Murthy
authors.forename: Shahriar
authors.initials: S
authors.lastname: Sedghi
authors.forename: Ronald
authors.initials: R
authors.lastname: Pruitt
authors.forename: Andrew C
authors.initials: AC
authors.lastname: Barrett
authors.forename: Enoch
authors.initials: E
authors.lastname: Bortey
authors.forename: Craig
authors.initials: C
authors.lastname: Paterson
authors.forename: William P
authors.initials: WP
authors.lastname: Forbes
authors.forename: Gary R
authors.initials: GR
authors.lastname: Lichtenstein
mesh_terms: D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003093:Colitis, Ulcerative / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004339:Drug Compounding; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D012074:Remission Induction; D012426:Russia; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D000893:Anti-Inflammatory Agents; D005765:Gastrointestinal Agents; D019804:Mesalamine