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1: Gastroenterology. 1998 Jan;114(1):15-22.Click here to read Links
Comment in:
Gastroenterology. 1998 Nov;115(5):1306-7.
Gastroenterology. 1999 Jun;116(6):1505-6.

Balsalazide is more effective and better tolerated than mesalamine in the treatment of acute ulcerative colitis. The Abacus Investigator Group.

Green JR, Lobo AJ, Holdsworth CD, Leicester RJ, Gibson JA, Kerr GD, Hodgson HJ, Parkins KJ, Taylor MD.

Gastroenterology unit, City General Hospital, Stoke-on-Trent, England.

BACKGROUND & AIMS: 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.

PMID: 9428213 [PubMed - indexed for MEDLINE]

Patient Drug Information

  • Mesalamine (Asacol® , Canasa® , Pentasa® , ...)

    Mesalamine is used to treat ulcerative colitis (a condition in which part or all of the lining of the colon [large intestine] is swollen or worn away). Mesalamine delayed-release tablets and controlled-release capsules m...

  • Balsalazide (Colazal® )

    Balsalazide is used to treat ulcerative colitis, a condition in which the bowel is inflamed. Balsalazide is an anti-inflammatory drug. It is converted in the body to mesalamine and works by reducing bowel inflammation, d...

  • Source: AHFS Consumer Medication Information