Mesalazine 4 g daily given as prolonged-release granules twice daily and four times daily is at least as effective as prolonged-release tablets four times daily in patients with ulcerative colitis

Background: High doses of mesalazine usually result in an inconvenient dosa ge schedule and reduced compliance. The goal of this trial was to compare t he effects of mesalazine 4 daily given as prolonged-release granules in pac kets of I with that of prolonged-release tablets of 0.5 g. Methods: Two hun dred twenty-seven patients with mild-to-moderate ulcerative colitis were ra ndomized to treatment with two packets twice daily (Gr-b.i.d.), I packet fo ur times daily (Gr-q.i.d.) or 2 tablets four times daily (Ta-q.i.d.) for 8 weeks. A disease activity index (ulcerative colitis disease activity index; UC-DAI) was calculated, and the granules were defined as noninferior to th e tablets if the lower limit of the 95% CI for the differences was more tha n -1 UC-DAI score unit. Results: Noninferiority of the granules compared wi th the tablets was demonstrated. The mean improvement in the UC-DAI in the treatment groups Gr-b.i.d., Gr-q.i.d., and Ta-q.i.d. were 3.2, 2.9, and 2.4 , respectively; the proportion of complete responders in the three groups 3 9%, 37%, and 31%, respectively. There were no differences in side effects. Conclusion: Mesalazine 4 g daily given as prolonged-release granules twice and four times daily is at least as effective as prolonged-release tablets four times daily in patients with mild to moderate ulcerative colitis. The patients preferred the twice daily closing.