title: Balsalazide is more effective and better tolerated than mesalamine in the treatment of acute ulcerative colitis. The Abacus Investigator Group.
abstract: OBJECTIVE
  Aminosalicylates are widely used in the treatment of ulcerative colitis (UC). Balsalazide is a novel mesalamine prodrug, activated by colonic bacteria. The aim of this study was to compare the efficacy and safety of balsalazide with that of a pH-dependent formulation of mesalamine in active UC.
  
  
  METHODS
  A randomized, double-blind study was performed comparing balasalazide, 6.75 g daily, with mesalamine, 2.4 g daily, administered for 4, 8, or 12 weeks to 101 (99 evaluable) patients with symptomatic, sigmoidoscopically verified UC.
  
  
  RESULTS
  More patients treated with balsalazide achieved symptomatic remission after 2 (64% [balsalazide] vs. 43% [mesalamine]), 4 (70% vs. 51%), 8 (78% vs. 45%), and 12 weeks (88% vs. 57%) and complete remission (none/mild symptoms, sigmoidoscopy grade 0/1, no rectal steroid use within 4 days) after 4 (38% vs. 12%), 8 (54% vs. 22%), and 12 weeks (62% vs. 37%). Patients taking balsalazide experienced more asymptomatic days (4 weeks, 24% vs. 14%) and achieved the first asymptomatic day more rapidly (median, 10 vs. 25 days). Fewer patients in the balsalazide group reported adverse events (48% vs. 71%); four serious adverse events occurred in the mesalamine group.
  
  
  CONCLUSIONS
  Balsalazide is more effective and better tolerated than mesalamine as treatment for acute UC.
authors.affiliation: Gastroenterology unit, City General Hospital, Stoke-on-Trent, England.
authors.forename: J R
authors.initials: JR
authors.lastname: Green
authors.forename: A J
authors.initials: AJ
authors.lastname: Lobo
authors.forename: C D
authors.initials: CD
authors.lastname: Holdsworth
authors.forename: R J
authors.initials: RJ
authors.lastname: Leicester
authors.forename: J A
authors.initials: JA
authors.lastname: Gibson
authors.forename: G D
authors.initials: GD
authors.lastname: Kerr
authors.forename: H J
authors.initials: HJ
authors.lastname: Hodgson
authors.forename: K J
authors.initials: KJ
authors.lastname: Parkins
authors.forename: M D
authors.initials: MD
authors.lastname: Taylor
mesh_terms: D000328:Adult; D000636:Aminosalicylic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D010659:Phenylhydrazines; D016896:Treatment Outcome
chemical_list: D000636:Aminosalicylic Acids; D000894:Anti-Inflammatory Agents, Non-Steroidal; D000897:Anti-Ulcer Agents; D010659:Phenylhydrazines; D019804:Mesalamine; C038637:balsalazide