Objectives: To determine the therapeutic equivalence and safety of once daily (OD) versus three times daily (TID) dosing of a total daily dose of 3 g Salofalk (mesalazine) granules in patients with active ulcerative colitis. Design: A randomised, double-blind, double-dummy, parallel group, multicentre, international, phase III noninferiority study. Setting: 54 centres in 13 countries. Patients: 380 patients with confirmed diagnosis of established or first attack of ulcerative colitis (clinical activity index (CAI).4 and endoscopic index >4 at baseline) were randomised and treated. Interventions: 8-week treatment with either 3 g OD or 1 g TID mesalazine granules. Main outcome measures: Clinical remission (CAI(4) at study end. Results: 380 patients were evaluable for efficacy and safety by intention-to-treat (ITT); 345 for per protocol (PP) analysis. In the ITT population, 79.1% in the OD group (n = 191) and 75.7% in the TID group (n = 189) achieved clinical remission (p,0.0001 for non-inferiority). Significantly more patients with proctosigmoiditis achieved clinical remission in the OD group (86%; n = 97) versus the TID group (73%; n = 100; p = 0.0298). About 70% of patients in both treatment groups achieved endoscopic remission, and 35% in the OD group and 41% in the TID group achieved histological remission. About 80% of all patients preferred OD dosing. Similar numbers of adverse events occurred in 55 patients (28.8%) in the OD group and in 61 patients (32.3%) in the TID group, indicating that the two dosing regimens were equally safe and well tolerated. Conclusions: OD 3 g mesalazine granules are as effective and safe as a TID 1 g schedule. With respect to the best possible adherence of patients to the treatment, OD dosing of mesalazine should be the preferred application mode in active ulcerative colitis. ClinicalTrials.gov Identifier: NCT00449722Aminosalicylates (mesalazine, sulfasalazine, olsalazine, balsalazide) have been the mainstay of inflammatory bowel disease treatment for over 60 years.1 These drugs are prescribed for active disease as well as for relapse prevention in both ulcerative colitis and in Crohn's disease. Aminosalicylates are the undisputed ''gold standard'' for maintaining remission in ulcerative colitis.2-4 Furthermore, they may have chemopreventive properties against colorectal cancer. 5Conventionally, a multiple daily dosing regimen of aminosalicylates is established. This is a demanding drug regimen, which can interfere with the everyday life of a patient, and can therefore reduce the quality of life. Moreover, the inconvenience of this dosing regimen can have a negative impact on adherence to the drugs, and thus, can lead to a poorer long-term prognosis. Adherence rates in prospective, community-based studies range from 40 to 60%, 6 7 and are particularly poor among patients in remission. [8][9][10][11] Three times per day (TID) dosing of mesalazine was the most significant risk factor for partial non-compliance. A total of 57% of patients who were prescribed mesalazine TID...

SUMMARY BackgroundComparative data regarding different regimens of oral mesalazine (mesalamine) for maintaining remission in ulcerative colitis are limited.

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SUMMARYBackground: Mesalazine as the treatment standard for ulcerative colitis can be applied in different galenical preparations. Aim: A novel formulation of mesalazine pellets with delayed and prolonged release characteristics was compared with conventional Eudragit L-coated tablets. Furthermore, the effect of mesalazine dose escalation on nonresponders was evaluated in both treatment groups. Methods: A total of 233 patients with mild to moderately active ulcerative colitis were randomized to receive either mesalazine (1.5 g/day in three doses) as pellets