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Gut. 2009 Feb;58(2):233-40. doi: 10.1136/gut.2008.154302. Epub 2008 Oct 2.

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

Collaborators (165)

Kozic M, Klarin I, Matas Z, Kasun D, Turcinov J, Marcelic R, Fixa B, Vanasek T, Gabalec L, Simon V, Kohout P, Kykal J, Vich T, Kull K, Salupere R, Remmel H, Koiva P, Labotkin K, Baniewicz W, Bonnet S, Vohmann B, Kruis W, Böhm S, Zeisler T, Zeus J, Banai J, Szamosi T, Czeglédi Z, Demeter P, Sike R, Penyige J, Bálint L, Sárdi K, Huoránszki F, Döbrönte Z, Lakner L, Jakab Z, Lakatos L, Mester G, Ferenc C, Rácz I, Szabó A, Pécsi G, Csöndes M, Saleh H, Kárász T, Tulassay Z, Herszényi L, Németh AM, Miheller P, Ujszászy L, Grenda A, Velösy B, Virányi Z, Dubravcsik Z, Bar-Meir S, Nadler M, Dotan I, Rosner G, Grenshpon R, Eliakim R, Chermesh I, Faszczyk M, Berezovsky A, Katz G, Keret D, Mindrul V, Lavy A, Keren D, Melzer E, Binder Y, Niv Y, Fraser GM, Zebeede E, Gal E, Derova J, Derovs A, Pokrotnieks J, Pukitis A, Ergle M, Acute G, Vainoriute V, Metrikis V, Cepulis A, Adamonis K, Modzeliauskas A, Buineviciute A, Samalavicius N, Radziunas G, Kiudelis G, Kupcinskas L, Jonaitis L, Simulionis G, Petrauskas S, Kuolas V, Vanagaitiene R, Jablonskis A, Navikiene A, Horynski M, Kleczkowski D, Kopon A, Kopon E, Marlicz K, Jaroszewicz-Heigelmann H, Binkowska I, Wasilewicz M, Sieron A, Latos W, Zieleznik W, Sieron-Stoltny K, Szczepanski L, Zwolak R, Chudzik D, Piotrowski M, Mazurek M, Wysokinski A, Grodzienski R, Kosikowski W, Drabko J, Forys A, Bakulin IG, Novozhenov VG, Ivanova MA, Ruseikin VM, Malabaev KD, Belousova EA, Mishurovskaya TS, Nikulina IV, Gorelov AI, Sishkova EA, Raspereza DV, Tinyakova TV, Grinevich VB, Gubonina IV, Pershko AM, Mikhailova TL, Golovenko OV, Mayat LA, Makarchuk PA, Malakhova NS, Yakovenko EP, Yakovenko AV, Agafonova NA, Pryanishnikova AS, Ivanov AN, Zhidkov KP, Bulavin ON, Albegova FD, Vasilukova MV, Barický B, Bátovský M, Pekárková B, Pekarek B, Stefanovic M, Tosovic Z, Ljepovic L, Dorofeyev A, Lynevskaya K, Rassokhina O, Lozynsky YS, Lozynska M, Golovchansky S, Zakharash MP, Zakharash Y, Kravchenko T.

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 3 g Salofalk (mesalazine) granules in patients with active ulcerative colitis.

DESIGN:

A randomised, double-blind, double-dummy, parallel group, multicentre, international, phase III non-inferiority 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 > or =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< or =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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00449722.

PMID:
18832520
[PubMed - indexed for MEDLINE]
PMCID:
PMC3269751
Free PMC Article
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