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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
  1. Wolfgang Kruis (gasser{at}evkk.de)
  1. Evangelisches Krankenhaus Kalk, Germany
    1. Gediminas Kiudelis
    1. Kaunas University of Medicine Hospital, Lithuania
      1. Istvan Racz
      1. Petz Aladar Megyei Korhaz I. Belgyogyaszat, Györ, Hungary
        1. Igorevich Aleksander Gorelov
        1. Central Medical-Sanitary Hospital #122, Moscow, Russian Federation
          1. Juris Pokrotnieks
          1. Latvian Gastroenterology Center - Paula Stradina University Hospital, Riga, Latvia
            1. Marek Horynski
            1. Centrum Medyczyne, Poland
              1. Marian Batovsky
              1. Derer's University Hospital, Bratislava, Slovakia
                1. Jan Kykal
                1. Hospital Ricany, Ricany, Czech Republic
                  1. Stephan K Böhm (boehm{at}evkk.de)
                  1. Evangelisches Krankenhaus Kalk, Germany
                    1. Roland Greinwald
                    1. Dr. Falk Pharma GmbH, Germany
                      1. Ralph Müller
                      1. Dr. Falk Pharma GmbH, Germany

                        Abstract

                        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® (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 £ 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.

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