title: Once-daily mesalamine granules for maintaining remission of ulcerative colitis: pooled analysis of efficacy, safety, and prognostic factors.
abstract: OBJECTIVE
  A capsule formulation of mesalamine granules (MG) was developed for once-daily dosing and better compliance. The study aim was to evaluate MG efficacy and tolerability in maintaining ulcerative colitis (UC) remission.
  
  
  METHODS
  Pooled analysis of 2 identical phase 3, randomized, double-blind trials of once-daily MG 1.5 g or placebo for up to 6 months. The primary endpoint was percentage of patients remaining relapse-free at month 6 versus placebo. Relapse was defined as revised Sutherland Disease Activity Index (SDAI) rectal bleeding score ≥1 and mucosal appearance score ≥2, UC flare, or UC-related adverse event (AE).
  
  
  RESULTS
  Data were pooled for patients receiving MG (n = 373) and placebo (n = 189). Significantly more patients were relapse-free at 6 months with MG (79.4%) than placebo (62.4%; P < 0.001) and across subgroups based on select demographic and baseline characteristics (P < 0.05). Secondary outcome measures including rectal bleeding, physician rating of disease activity, stool frequency, total SDAI score, and relapse-free duration favored MG (P < 0.01). Common AEs with MG and placebo, respectively, were headache (10.9% and 7.6%), diarrhea (7.9% and 7.0%), and abdominal pain (6.3% and 6.5%).
  
  
  CONCLUSIONS
  Once-daily MG was more efficacious than and as well tolerated as placebo in maintaining UC remission. ClinicalTrials.gov identifiers: NCT00744016 and NCT00767728.
authors: a Connecticut Gastroenterology Institute , Bristol Hospital , Bristol , Connecticut , USA.
authors: Salam F
authors: SF
authors: Zakko
authors: b Center for Digestive and Liver Diseases, Inc ., Mexico , Missouri , USA.
authors: Glenn L
authors: GL
authors: Gordon
authors: c Department of Medicine , Syracuse VA Medical Center , Syracuse , New York , USA.
authors: Uma
authors: U
authors: Murthy
authors: d Gastroenterology Associates of Central Georgia, LLC , Macon , Georgia , USA.
authors: Shahriar
authors: S
authors: Sedghi
authors: e Nashville Medical Research Institute and The Maria Nathanson Center at Saint Thomas Hospital , Nashville , Tennessee , USA.
authors: Ronald
authors: R
authors: Pruitt
authors: f Salix, a Division of Valeant Pharmaceuticals North America LLC , Bridgewater , NJ , USA.
authors: Andrew C
authors: AC
authors: Barrett
authors: f Salix, a Division of Valeant Pharmaceuticals North America LLC , Bridgewater , NJ , USA.
authors: Enoch
authors: E
authors: Bortey
authors: f Salix, a Division of Valeant Pharmaceuticals North America LLC , Bridgewater , NJ , USA.
authors: Craig
authors: C
authors: Paterson
authors: f Salix, a Division of Valeant Pharmaceuticals North America LLC , Bridgewater , NJ , USA.
authors: William P
authors: WP
authors: Forbes
authors: g Department of Medicine , University of Pennsylvania School of Medicine , Philadelphia , Pennsylvania , USA.
authors: Gary R
authors: GR
authors: Lichtenstein
mesh_terms: D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D002214:Capsules; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004311:Double-Blind Method; D006801:Humans; D060046:Maintenance Chemotherapy / Q000379:methods; D019804:Mesalamine / Q000008:administration & dosage*; D008875:Middle Aged; D011379:Prognosis; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D002214:Capsules; D019804:Mesalamine
keywords: Inflammatory bowel disease; mesalamine; remission; ulcerative colitis