BALSALAZIDE IS MORE EFFECTIVE AND BETTER TOLERATED THAN MESALAMINE INTHE TREATMENT OF ACUTE ULCERATIVE-COLITIS

Background & Aims: Aminosalicylates are widely used in the treatment o f ulcerative colitis (UC). Balsalazide is a novel mesalamine prodrug, activated by colonic bacteria. The aim of this study was to compare th e efficacy and safety of balsalazide with that of a pH-dependent formu lation of mesalamine in active UC. Methods: A randomized, double-blind study was performed comparing balsalazide, 6.75 g daily, with mesalam ine, 2.4 g daily, administered for 4, 8, or 12 weeks to 101 (99 evalua ble) patients with symptomatic, sigmoidoscopically verified UC. Result s: More patients treated with balsalazide achieved symptomatic remissi on after 2 (64% [balsalazide] vs. 43% [mesalamine]), 4 (70% vs. 51%), 8 (78% vs. 45%), and 12 weeks (88% vs. 57%) and complete remission (no ne/mild symptoms, sigmoidoscopy grade 0/1, no rectal steroid use withi n 4 days) after 4 (38%;, vs. 12%), 8 (54% vs. 22%), and 12 weeks (62% vs. 37%). Patients taking balsalazide experienced more asymptomatic da ys (4 weeks, 24% vs. 14%) and achieved the first asymptomatic day more rapidly (median, 10 vs. 25 days). Fewer patients in the balsalazide g roup reported adverse events (48% vs. 71%); four serious adverse event s occurred in the mesalamine group. Conclusions: Balsalazide is more e ffective and better tolerated than mesalamine as treatment for acute U C.