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Mesalamine Once Daily As Good As Twice Daily in Mild to Moderate Ulcerative Proctitis: Presented at WCOG By Danny Kucharsky MONTREAL, CANADA -- September 15, 2005 -- Mesalamine is equally effective in once-a-day or twice-a-day formulations for the treatment of patients with mild to moderate ulcerative proctitis, a study presented here on September 14th at the World Congress of Gastroenterology (WCOG) finds. Conducted in 18 centres in 3 countries, the goal of the randomised therapeutic equivalency trial was to compare the efficacy of 2 types of mesalamine dosages -- 1-g HS at night or 2 times a day (500-mg BID) -- after 6 weeks of treatment. Both dosages have been previously found to be safe and effective treatments for 3 weeks in ulcerative proctitis, said study leader Mark Lamet, MD, gastroenterologist, Center for Gastrointestinal Disorders in Hollywood, Florida, United States. The study, which was also published in the July issue of the Journal of Inflammatory Bowel Disease (2005 Jul;11[7]:625-30), enrolled 99 adults who were confirmed positive for ulcerative proctitis by endoscopy and a disease activity index (DAI) value between 4 and 9. Results showed no significant difference in disease activity index (DAI) at 6 weeks (P = .73) or 3 weeks (P = .87) between treatments adjusted for baseline DAI. At baseline, the mean DAI was 6.6 among the 48 patients in the 500-mg BID group. At 6 weeks, it declined to 1.6 among the 46 patients who remained in that group. In the 1-g HS group, the mean DAI was 6.1 at baseline for 39 patients, declining to 1.3 at week 6 for the 36 patients who completed treatment. Both groups showed significant improvement (P < .001) in DAI scores following both 3 and 6 weeks of treatment. There were adverse events related to treatment in 17% of patients (11 events) in the 500-mg BID group and 20% of patients (18 events) in the 1-g HS group. There was no difference in compliance, with both groups averaging more than 95%. Comparisons of DAI between 3 and 6 weeks showed significant improvement, Dr. Lamet said, which established that more patients reached complete response with additional treatment. As well, the once-a-day formulation should lead to better patient compliance and ease of use, he said. The study received support from Axcan Pharma in Canada. [Presentation title: Efficacy and Safety of Mesalamine 500 mg BID vs. Ig HS Suppositories in Mild to Moderate Ulcerative Proctitis. Abstract R.0465] E-mail this page to a friend or colleague! To print, use this version