Safety and Efficacy of a New 3.3 g b.i.d. Tablet Formulation in Patients With Mild-to-Moderately-Active Ulcerative Colitis: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

Scherl, Ellen J.; Pruitt, Ronald; Gordon, Glenn L.; Lamet, Mark; Shaw, Audrey; Huang, Shirley; Mareya, Shadreck; Forbes, William P.
June 2009
American Journal of Gastroenterology;Jun2009, Vol. 104 Issue 6, p1452
Academic Journal
OBJECTIVES:To evaluate the safety and efficacy of a new twice-daily balsalazide disodium 1.1 g tablet dosing regimen (6.6 g/day, three tablets twice daily) for the treatment of mild-to-moderately-active ulcerative colitis (UC).METHODS:In a double-blind, multicenter study patients with symptoms of acute UC and a baseline Modified Mayo Disease Activity Index (MMDAI) score between 6 and 10, inclusive, with a subscale rating of ≥2 for both rectal bleeding and mucosal appearance were randomized to receive 3.3 g of balsalazide or placebo tablets twice daily for 8 weeks. The primary end point was the proportion of patients achieving clinical improvement (≥3 point improvement in MMDAI) and improvement in rectal bleeding (≥1 point improvement) at 8 weeks. Safety assessments were conducted from baseline through 2-weeks post-treatment.RESULTS:A total of 249 patients (166 balsalazide, 83 placebo) received at least 1 dose of study medication. The mean MMDAI score at baseline was 7.9; 62% of patients had a score ≥8.0 (moderate disease). A significantly larger proportion of patients achieved clinical improvement and improvement in rectal bleeding in the balsalazide group vs. the placebo group (55 vs. 40%, P=0.02). The most common adverse events reported were worsening of UC and headache; both were reported more often in the placebo group.CONCLUSIONS:Balsalazide disodium 1.1 g tablets administered as 3.3 g twice daily are effective, well tolerated and significantly better than placebo for improving signs and symptoms of mild-to-moderately-active UC. This new formulation with a reduced pill and dosing burden offers the potential to improve convenience and compliance in patients with active UC.Am J Gastroenterol 2009; 104:1452–1459; doi:10.1038/ajg.2009.83; published online 21 April 2009


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