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A randomised trial comparing 4.8 vs 2.4 g/day of oral mesalazine for maintenance of remission in ulcerative colitis

Digestive and Liver Disease, In Press, Accepted Manuscript, Available online 28 July 2015, January 1970

Abstract

Background

Mesalazine is used as maintenance therapy in ulcerative colitis but the optimal dosage is still controversial.

Aim

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 randomised controlled trial.

Methods

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 (n = 56, Group A) or 2.4 g (n = 56, Group B).

Results

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 (p = 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, p = 0.0095) and in those with extensive disease (90.9% Group A vs. 46.7% Group B; Fisher's exact test, p = 0.0064).

Conclusions

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.

Keywords: ulcerative colitis, mesalazine, daily dosage, maintenance of remission..

Footnotes

a IBD Unit, Division of Gastroenterology and Digestive Endoscopy, Sandro Pertini Hospital, Rome, Italy

b Department of Internal Medicine and Medical Specialties, Gastroenterology Unit, “Sapienza”, University of Rome, Italy

Corresponding author. Unit of Gastroenterology and Digestive Endoscopy, Sandro Pertini Hospital, Via dei Monti Tiburtini n(385, 00157 Rome, Italy. Tel.: +39 06 41433310; fax: +39 06 41733847