Once daily versus three times daily mesalazine granules in active ulcerative colitis : A double-blind, double-dummy, randomised, non-inferiority trial

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dc.contributor.authorKruis, W.
dc.contributor.authorKiudelis, G.
dc.contributor.authorRácz, I.
dc.contributor.authorGorelov, A.
dc.contributor.authorPokrotnieks, J.
dc.contributor.authorHorynski, M.
dc.contributor.authorBatovsky, M.
dc.contributor.authorKykal, J.
dc.contributor.authorBoehm, S.
dc.contributor.authorGreinwald, R.
dc.contributor.authorMueller, R.
dc.date.accessioned2021-12-14T09:20:03Z
dc.date.available2021-12-14T09:20:03Z
dc.date.issued2009-02
dc.descriptionA list of investigators of the International Salofalk OD Study Group is given in the appendix. Investigators from Latvia are: Jelena Derova, Aleksejs Derovs, Juris Pokrotnieks, Aldis Pukitis, Mairita Ergle.
dc.description.abstractObjectives: 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: NCT00449722.en
dc.description.statusPeer reviewed
dc.format.extent8
dc.format.extent330457
dc.identifier.citationKruis, W, Kiudelis, G, Rácz, I, Gorelov, A, Pokrotnieks, J, Horynski, M, Batovsky, M, Kykal, J, Boehm, S, Greinwald, R & Mueller, R 2009, 'Once daily versus three times daily mesalazine granules in active ulcerative colitis : A double-blind, double-dummy, randomised, non-inferiority trial', Gut, vol. 58, no. 2, pp. 233-240. https://doi.org/10.1136/gut.2008.154302
dc.identifier.doi10.1136/gut.2008.154302
dc.identifier.issn0017-5749
dc.identifier.urihttps://dspace.rsu.lv/jspui/handle/123456789/7042
dc.identifier.urlhttp://www.scopus.com/inward/record.url?scp=58849136710&partnerID=8YFLogxK
dc.language.isoeng
dc.relation.ispartofGut
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subject3.2 Clinical medicine
dc.subject1.1. Scientific article indexed in Web of Science and/or Scopus database
dc.subjectGastroenterology
dc.titleOnce daily versus three times daily mesalazine granules in active ulcerative colitis : A double-blind, double-dummy, randomised, non-inferiority trialen
dc.type/dk/atira/pure/researchoutput/researchoutputtypes/contributiontojournal/article

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