TY - JOUR T1 - Randomised trial of once- or twice-daily MMX mesalazine for maintenance of remission in ulcerative colitis JF - Gut JO - Gut SP - 893 LP - 902 DO - 10.1136/gut.2007.138248 VL - 57 IS - 7 AU - M A Kamm AU - G R Lichtenstein AU - W J Sandborn AU - S Schreiber AU - K Lees AU - K Barrett AU - R Joseph Y1 - 2008/07/01 UR - http://gut.bmj.com/content/57/7/893.abstract N2 - Aim: Maintenance treatment in ulcerative colitis should be as convenient as possible, to increase the chance of compliance. MMX mesalazine is a once-daily, high-strength (1.2 g/tablet) formulation of 5-aminosalicylic acid. This study evaluated the safety and efficacy of MMX mesalazine dosed once or twice daily as maintenance therapy in patients with ulcerative colitis.Methods: This multicentre, randomised, open-label trial enrolled patients with strictly defined clinical and endoscopic remission, immediately following an episode of mild to moderate ulcerative colitis. Patients were randomised to MMX mesalazine 2.4 g/day as a single (2×1.2 g tablet) or divided dose (1×1.2 g tablet twice daily) for 12 months.Results: 174 patients (37.9%; safety population n = 459) experienced 384 adverse events, the majority of which were mild or moderate in intensity. Eighteen patients (3.9%), nine in each group, experienced a total of 22 serious adverse events (10 in the once-daily and 12 in the twice-daily group). Most serious adverse events were gastrointestinal, experienced by 5 patients in the once-daily and 4 in the twice-daily group. At month 12, 64.4% (efficacy population, n = 451) of patients in the once-daily and 68.5% of patients in the twice-daily group were in clinical and endoscopic remission (p = 0.351). At month 12, 88.9% and 93.2% in each group, respectively, had maintained clinical remission (were relapse free).Conclusions: MMX mesalazine 2.4 g/day administered as a single or divided dose demonstrated a good safety profile, was well tolerated and was effective as maintenance treatment. High clinical and endoscopic remission rates can be achieved with once-daily dosing.Trial registration number: NCT00151944. ER -