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1: Gut. 2008 Oct 2. [Epub ahead of print]
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Once-daily versus three-times-daily mesalazine granules in active ulcerative colitis: A double-blind, double-dummy, randomised non-inferiority trial.

Kruis W, Kiudelis G, Racz I, Gorelov IA, Pokrotnieks J, Horynski M, Batovsky M, Kykal J, Böhm SK, Greinwald R, Müller R.

Germany.

OBJECTIVES: To determine the therapeutic equivalence and safety of once daily (OD) versus three times daily (TID) dosing of a total daily dose of 3g Salofalk(R) (mesalazine) granules in patients with active ulcerative colitis (UC). DESIGN: A randomised, double-blind, double-dummy, parallel group, multicentre, international, Phase III non-inferiority study. SETTING: 54 centers in 13 countries. PATIENTS: 380 patients with confirmed diagnosis of established or first attack of UC (Clinical Activity Index [CAI] > 4 and Endoscopical Index >/= 4 at baseline) were randomized and treated. INTERVENTIONS: 8-week treatment with either 3g OD or 1g TID mesalazine granules. MAIN OUTCOME MEASURES: Clinical remission (CAI pound 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 PP population, 83% in the OD group (N=171) and 78% in the TID group (N=174) achieved clinical remission (p<0.0001 for non-inferiority). Significantly more patients (ITT) 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 (ITT) achieved endoscopical remission, and 41% in the OD group and 47% in the TID group achieved histological remission (ITT). About 80% of all patients preferred a OD dosing. The two dosing regimens were equally safe and well-tolerated. CONCLUSIONS: OD 3g mesalazine granules are as effective and safe as a TID 1g schedule. With respect to the best possible adherence of the patients to the treatment, OD dosing of mesalazine should be the preferred application mode in active UC.

PMID: 18832520 [PubMed - as supplied by publisher]