Oral mesalamine (Asacol) for mildly to moderately active ulcerative colitis. A multicenter study

Area of Science:

• Gastroenterology
• Pharmacology

Background:

• Ulcerative colitis (UC) is a chronic inflammatory bowel disease.
• Effective and safe oral therapies are crucial for managing mild to moderate UC.
• Current treatments may have limitations or side effects.

Purpose of the Study:

• To assess the efficacy and safety of a novel pH-sensitive, polymer-coated oral mesalamine formulation.
• To determine optimal dosing for treating active ulcerative colitis.

Main Methods:

• A multicenter, double-blind, placebo-controlled randomized trial.
• 158 patients with active ulcerative colitis received oral mesalamine (1.6 or 2.4 g/d) or placebo for 6 weeks.
• Efficacy was evaluated using clinical scores, sigmoidoscopic findings, and global assessments.

Main Results:

• Significant improvements in ulcerative colitis symptoms were observed at 3 weeks with 2.4 g/d mesalamine compared to placebo.
• Both 1.6 g/d and 2.4 g/d mesalamine doses were significantly superior to placebo at 6 weeks.
• The oral mesalamine preparation was well-tolerated with no significant adverse laboratory findings.

Conclusions:

• Colon-targeted oral mesalamine at 2.4 g/d is an effective therapy for mild to moderate ulcerative colitis.
• This formulation offers a well-tolerated and viable alternative to existing treatments like sulfasalazine.