Safety and efficacy of a new 3.3g b.i.d. tablet formulation in patients with mild-to-moderately-active ulcerative colitis: A multicenter, randomized, double-blind, placebo-controlled study

OBJECTIVES:To evaluate the safety and efficacy of a new twice-daily balsalazide disodium 1.1g tablet dosing regimen (6.6gday, 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 3.3g 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, P0.02). The most common adverse events reported were worsening of UC and headache; both were reported more often in the placebo group.CONCLUSIONS: Balsalazide disodium 1.1g tablets administered as 3.3g 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.