A randomized trial comparing 4.8 vs. 2.4 g/day of oral mesalazine for maintenance of remission in ulcerative colitis. Issue 11 (November 2015)

• Record Type: Journal Article
• Authors: Pica, Roberta; Cassieri, Claudio; Cocco, Andrea; Zippi, Maddalena; Marcheggiano, Adriana; De Nitto, Daniela; Avallone, Eleonora Veronica; Crispino, Pietro; Occhigrossi, Giuseppe; Paoluzi, Paolo
• Is Part Of: Digestive and liver disease. Volume 47:Issue 11(2015)
• Page Start: 933
• Page End: 937
• Publication Date: 2015-11
• Subjects: Digestive organs -- Diseases -- Periodicals; Liver -- Diseases -- Periodicals; 616.33005
• DOI: 10.1016/j.dld.2015.07.011
• Languages: English
• ISSNs: 1590-8658

Abstract

<abstract abstract-type="author" id="abs0005"> <title id="sect0005">Abstract</title> <sec> <title id="sect0010">Background</title> <p id="spar0005">Mesalazine is used as maintenance therapy in ulcerative colitis but the optimal dosage is still controversial.</p> </sec> <sec> <title id="sect0015">Aim</title> <p id="spar0010">To compare the remission-maintenance efficacy and tolerability of two daily doses of oral mesalazine (4.8 g and 2.4 g) in patients with ulcerative colitis with frequent relapses in a randomized controlled trial.</p> </sec> <sec> <title id="sect0020">Methods</title> <p id="spar0015">112 ulcerative colitis patients in remission were enrolled and randomly allocated to treatment for 1 year with oral mesalazine at a daily dose of 4.8 g (<italic>n</italic> = 56, Group A) or 2.4 g (<italic>n</italic> = 56, Group B).</p> </sec> <sec> <title id="sect0025">Results</title> <p id="spar0020">At the end of the 12 months, intention to treat analysis revealed persistent remission in 42 (75%) in Group A and 36 (64.2%) in Group B (<italic>p</italic> = 0.3). The higher daily dose (4.8 g) proved to be significantly more effective for maintaining remission in patients under 40 years of age (90.5% Group A vs. 50% Group B; Fisher's exact test, <italic>p</italic> = 0.0095) and in those with extensive disease (90.9% Group A vs. 46.7% Group B; Fisher's exact test, <italic>p</italic> = 0.0064).</p> </sec> <sec> <title id="sect0030">Conclusions</title> <p id="spar0025">In ulcerative colitis patients younger than 40 years and/or with extensive disease, a daily dose of 4.8 g oral mesalazine results in increased rates and duration of remission compared to 2.4 g.</p> </sec> </abstract>