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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

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

Ellen J Scherl, Ronald Pruitt, Glenn L Gordon, Mark Lamet, Audrey Shaw, Shirley Huang, Shadreck Mareya, William P Forbes

Am J Gastroenterol. 2009 Jun;104(6):1452-9.

PMID: 19491859

Abstract:

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 > or =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 (> or =3 point improvement in MMDAI) and improvement in rectal bleeding (> or =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 > or =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.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP150399216	Balsalazide disodium		150399-21-6	Price

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