{Reference Type}: Comparative Study
{Title}: A randomized trial comparing 4.8 vs. 2.4 g/day of oral mesalazine for maintenance of remission in ulcerative colitis.
{Author}: Pica R;Cassieri C;Cocco A;Zippi M;Marcheggiano A;De Nitto D;Avallone EV;Crispino P;Occhigrossi G;Paoluzi P;
{Journal}: Dig Liver Dis
{Volume}: 47
{Issue}: 11
{Year}: Nov 2015
{Factor}: 5.165
{DOI}: 10.1016/j.dld.2015.07.011
{Abstract}: <B>BACKGROUND: </B>Mesalazine is used as maintenance therapy in ulcerative colitis but the optimal dosage is still controversial.<BR><B>OBJECTIVE: </B>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.<BR><B>METHODS: </B>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).<BR><B>RESULTS: </B>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).<BR><B>CONCLUSIONS: </B>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.