Pooled data from two phase III trials reported at the Digestive Disease Week meeting show that Proctor & Gamble's Asacol® (mesalamine) delayed-release 400 mg tablets (2.4 g/day) and investigational 800 mg mesalamine tablets (4.8 g/day) induced mucosal healing in patients with moderately active ulcerative colitis (UC). Healing was measured by endoscopy.

Lead author Gary R. Lichtenstein, MD, Director of the Center for Inflammatory Bowel Diseases at the Hospital of the University of Pennsylvania in Philadelphia, presented the analysis in a poster titled "Endoscopically measured mucosal healing of delayed-release oral mesalamine 4.8 g/day versus 2.4 g/day." The analysis pooled data from two multicenter, randomized, double-blind, 6-week, controlled phase III studies of similar design (ASCEND I and II).

Two treatment groups were analyzed: one was given Asacol 2.4 g/day and the other was given 4.8 g/day of mesalamine. Mucosal healing was verified at 3 weeks in 65 percent of patients taking 4.8 g/day mesalamine and at 6 weeks in 80 percent of these patients. In the lower dose group, mucosal healing occurred in 58 percent of patients at 3 weeks and in 68 percent by 6 weeks. Mucosal healing was defined as an endoscopy subscore of 0 or 1.

Patients had moderately active ulcerative colitis at baseline (defined as a Physician's Global Assessment score of 2) and a baseline endoscopy subscore >e;2. The two studies included 423 evaluable patients, 391 of whom were included in this analysis.

Asacol is indicated for the treatment of mild-to-moderate active UC (two 400 mg tablets tid for 6 weeks) and for the maintenance of remission of UC (1.6 g/day in divided doses).

— A. Techman