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.

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.

• Authors: Ellen J Scherl, Ronald Pruitt, Glenn L Gordon, Mark Lamet, Audrey Shaw, Shirley Huang, Shadreck Mareya, William P Forbes
• Journal: The American journal of gastroenterology (Am J Gastroenterol) Vol. 104 Issue 6 Pg. 1452-9 (Jun 2009) ISSN: 1572-0241 [Electronic] United States
• PMID: 19491859 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Phenylhydrazines
• Tablets
• Mesalamine
• balsalazide

Topics

• Adult
• Aged
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage)
• Colitis, Ulcerative (complications, diagnosis, drug therapy)
• Disease Progression
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Gastrointestinal Hemorrhage (etiology, pathology, prevention & control)
• Humans
• Male
• Mesalamine (administration & dosage)
• Middle Aged
• Phenylhydrazines (administration & dosage)
• Prospective Studies
• Rectum
• Severity of Illness Index
• Sigmoidoscopy
• Tablets
• Treatment Outcome