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| |  Granulated Mesalamine Maintains Remission in Ulcerative Colitis: Presented at ACG By Deborah Brauser ORLANDO, Fla -- October 10, 2008 -- A once-daily 1.5-g dose of granulated mesalamine is effective in maintaining remission of ulcerative colitis (UC), according to results from a phase 3 trial presented here at the American College of Gastroenterology (ACG) 73rd Annual Scientific Meeting. Lead investigator Glenn Gordon, MD, Center for Digestive and Liver Diseases, Inc., Mexico, Missouri, presented the study results here in a poster session on October 5. Test subjects were made up of approximately 300 patients with documented remission of UC, as defined by the revised Sutherland Disease Activity Index (DAI) subscores of 0 for rectal bleeding and <2 for mucosal appearance. Patients were randomised to receive a daily 1.5-g (4 x 375 mg) dose of granulated mesalamine capsules or matching placebo capsules for 6 months. A total of 144 patients on mesalamine and 49 on placebo completed the study. The study's primary endpoint was the proportion of relapse-free patients after 6 months of treatment, based on the revised Sutherland DAI subscores. Patients who reported a UC flare or who required initiation of medication to treat UC were considered treatment failures. At the trial's conclusion, results showed that a significantly greater percentage of the mesalamine patients maintained long-term UC remission than those in the placebo group (79% vs 58%; P < .001). By month 6, patients treated with mesalamine had a clinically favourable change from baseline in physician-rated disease activity compared with placebo (78% vs 64%; P = .005), and a higher probability of remaining relapse-free (77%; 95% confidence interval [CI], 0.71-0.83) compared with placebo (56%; 95% CI, 0.46-0.67; P < .001). Percentages of patients per adverse event were identical in the 2 treatment groups at 64%, and most events were mild or moderate in intensity. Among patients treated with mesalamine, 11% experienced an adverse event of UC flare compared with 27% in the placebo group. "I think the main thing you see from these results is that this single, once-a-day dosing product -- a truly indicated one, not like the others that are really not indicated -- maintains [UC] remission by giving sustained release with a dual action modality and long-lasting results," Dr. Gordon said. "And for a subset of this population, they do very, very well with it." Funding for this study was provided by Salix Pharmaceuticals.
[Presentation title: Once-Daily 1.5-g Granulated Mesalamine Is Effective and Safe in Maintenance of Remission in Mild-to-Moderate Ulcerative Colitis. Abstract P-279]
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