Abstract | OBJECTIVES: 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.
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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)
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Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- Phenylhydrazines
- Tablets
- Mesalamine
- balsalazide
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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
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