Efficacy & Safety Of Mesalamine 2.4 G/D In The Treatment Of Mild To Moderate Uc: Combined Analysis From Ascend I & Ii

Mesalamine delayed-release tablets (Asacol) have been a mainstay in the treatment of ulcerative colitis (UC) for almost 15 years. An earlier study demonstrated the superior efficacy of Asacol 2.4 g/day vs placebo in mildly to moderately active UC, including patients with pancolitis, left-sided disease, and proctitis. To report the efficacy and safety of Asacol 2.4 g/day observed in two recent, large clinical studies. Two, prospective, 6-week, double-blind, randomized, multi-center, activecontrol studies (ASCEND I & II) were conducted to evaluate the efficacy and safety of Asacol in the treatment of mildly to moderately active UC. To be included in the studies, patients had to have a baseline score in either or both the rectal bleeding and stool frequency clinical assessments of at least 1 (based on 4 point scale, 0-4). This analysis includes data from the 2.4 g/day active control arms of these two studies. The hallmark symptom of active UC is bloody diarrhea; thus, clinically significant endpoints of interest were improvement in rectal bleeding and stool frequency. Improvement in rectal bleeding and stool frequency was defined as a decrease from baseline of at least 1 point/grade. Adverse events and changes in laboratory parameters were also assessed. A total of 687 patients were randomized in the two studies, of which 349 received Asacol 2.4 g/day. Based on patient diary data, the median time to total symptom resolution was 10 days for rectal bleeding and 11 days for stool frequency. In addition, as early as 3 weeks, 64% and 55% of patients experienced improvement in rectal bleeding and stool frequency, respectively, and this increased to 77% and 70% at 6 weeks. Asacol was effective in patients with pancolitis, left-sided disease, and proctitis (Table): Asacol 2.4 g/day: Efficacy Throughout the Colon Asacol 2.4 g/day: Efficacy Throughout the Colon Asacol 2.4 g/day was well-tolerated, with adverse events and laboratory findings consistent with those described in previoustrials and the current prescribing information. This is the largest clinical study program of delayed-release mesalamine and confirms previous results that Asacol is an effective therapy for mildly to moderately active UC, with an excellent safety profile. The analysis also confirms the use of Asacol in patients with all extents of mildly to moderately active UC, from proctitis to pancolitis.