Randomised clinical trial: A comparative dose-finding study of three arms of dual release mesalazine for maintaining remission in ulcerative colitis

W. Kruis, L. Jonaitis, J. Pokrotnieks, T. L. Mikhailova, M. Horynski, M. Bátovskã, Y. S. Lozynsky, Y. Zakharash, I. Rácz, K. Kull, A. Vcev, M. Faszczyk, K. Dilger, R. Greinwald, R. Mueller

Research output: Contribution to journalArticle

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Abstract

Background Comparative data regarding different regimens of oral mesalazine (mesalamine) for maintaining remission in ulcerative colitis are limited. Aim To evaluate whether 3.0 g mesalazine once-daily (OD) is superior to the standard treatment of 0.5 g mesalazine three times daily (t.d.s.) and to prove the therapeutic equivalence of OD vs. t.d.s. dosing of total 1.5 g mesalazine for remission maintenance in patients with ulcerative colitis. Methods A 1-year, multicentre, double-blind, double-dummy study was undertaken in patients with endoscopically and histologically confirmed ulcerative colitis in remission. Patients were randomised to oral mesalazine 3.0 g OD, 1.5 g OD or 0.5 g t.d.s. The primary efficacy endpoint was the proportion of patients still in clinical remission at the final visit, with clinical relapse being defined as CAI score >4 and an increase of â¥3 from baseline. Results The primary efficacy endpoint occurred in 162/217 3.0 g OD patients (75%), 129/212 1.5 g OD patients (61%) and 150/218 0.5 g t.d.s. patients (69%) in the intention-to-treat population, and in 152/177 (86%), 121/182 (67%) and 144/185 (78%) in the per protocol population respectively; 3.0 g OD was superior to both low-dose regimens for the primary endpoint (i.e. P <0.001, 3.0 g OD vs. 1.5 g OD; P = 0.024, 3.0 g OD vs. 0.5 g t.d.s.; superiority test, per protocol population). Safety analysis, including comprehensive renal monitoring, revealed no concern in any treatment group. Conclusion Mesalazine 3.0 g once daily was the most effective dose for maintenance of remission in ulcerative colitis of the three regimens assessed, with no penalty in terms of safety.

Original languageEnglish
Pages (from-to)313-322
Number of pages10
JournalAlimentary Pharmacology and Therapeutics
Volume33
Issue number3
DOIs
Publication statusPublished - Feb 2011

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Mesalamine
Ulcerative Colitis
Randomized Controlled Trials
Maintenance
Population
Safety
Double-Blind Method
Therapeutics
Kidney
Recurrence

ASJC Scopus subject areas

  • Pharmacology (medical)

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Randomised clinical trial : A comparative dose-finding study of three arms of dual release mesalazine for maintaining remission in ulcerative colitis. / Kruis, W.; Jonaitis, L.; Pokrotnieks, J.; Mikhailova, T. L.; Horynski, M.; Bátovskã, M.; Lozynsky, Y. S.; Zakharash, Y.; Rácz, I.; Kull, K.; Vcev, A.; Faszczyk, M.; Dilger, K.; Greinwald, R.; Mueller, R.

In: Alimentary Pharmacology and Therapeutics, Vol. 33, No. 3, 02.2011, p. 313-322.

Research output: Contribution to journalArticle

Kruis, W, Jonaitis, L, Pokrotnieks, J, Mikhailova, TL, Horynski, M, Bátovskã, M, Lozynsky, YS, Zakharash, Y, Rácz, I, Kull, K, Vcev, A, Faszczyk, M, Dilger, K, Greinwald, R & Mueller, R 2011, 'Randomised clinical trial: A comparative dose-finding study of three arms of dual release mesalazine for maintaining remission in ulcerative colitis', Alimentary Pharmacology and Therapeutics, vol. 33, no. 3, pp. 313-322. https://doi.org/10.1111/j.1365-2036.2010.04537.x
Kruis, W. ; Jonaitis, L. ; Pokrotnieks, J. ; Mikhailova, T. L. ; Horynski, M. ; Bátovskã, M. ; Lozynsky, Y. S. ; Zakharash, Y. ; Rácz, I. ; Kull, K. ; Vcev, A. ; Faszczyk, M. ; Dilger, K. ; Greinwald, R. ; Mueller, R. / Randomised clinical trial : A comparative dose-finding study of three arms of dual release mesalazine for maintaining remission in ulcerative colitis. In: Alimentary Pharmacology and Therapeutics. 2011 ; Vol. 33, No. 3. pp. 313-322.
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abstract = "Background Comparative data regarding different regimens of oral mesalazine (mesalamine) for maintaining remission in ulcerative colitis are limited. Aim To evaluate whether 3.0 g mesalazine once-daily (OD) is superior to the standard treatment of 0.5 g mesalazine three times daily (t.d.s.) and to prove the therapeutic equivalence of OD vs. t.d.s. dosing of total 1.5 g mesalazine for remission maintenance in patients with ulcerative colitis. Methods A 1-year, multicentre, double-blind, double-dummy study was undertaken in patients with endoscopically and histologically confirmed ulcerative colitis in remission. Patients were randomised to oral mesalazine 3.0 g OD, 1.5 g OD or 0.5 g t.d.s. The primary efficacy endpoint was the proportion of patients still in clinical remission at the final visit, with clinical relapse being defined as CAI score >4 and an increase of {\^a}¥3 from baseline. Results The primary efficacy endpoint occurred in 162/217 3.0 g OD patients (75{\%}), 129/212 1.5 g OD patients (61{\%}) and 150/218 0.5 g t.d.s. patients (69{\%}) in the intention-to-treat population, and in 152/177 (86{\%}), 121/182 (67{\%}) and 144/185 (78{\%}) in the per protocol population respectively; 3.0 g OD was superior to both low-dose regimens for the primary endpoint (i.e. P <0.001, 3.0 g OD vs. 1.5 g OD; P = 0.024, 3.0 g OD vs. 0.5 g t.d.s.; superiority test, per protocol population). Safety analysis, including comprehensive renal monitoring, revealed no concern in any treatment group. Conclusion Mesalazine 3.0 g once daily was the most effective dose for maintenance of remission in ulcerative colitis of the three regimens assessed, with no penalty in terms of safety.",
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T2 - A comparative dose-finding study of three arms of dual release mesalazine for maintaining remission in ulcerative colitis

AU - Kruis, W.

AU - Jonaitis, L.

AU - Pokrotnieks, J.

AU - Mikhailova, T. L.

AU - Horynski, M.

AU - Bátovskã, M.

AU - Lozynsky, Y. S.

AU - Zakharash, Y.

AU - Rácz, I.

AU - Kull, K.

AU - Vcev, A.

AU - Faszczyk, M.

AU - Dilger, K.

AU - Greinwald, R.

AU - Mueller, R.

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N2 - Background Comparative data regarding different regimens of oral mesalazine (mesalamine) for maintaining remission in ulcerative colitis are limited. Aim To evaluate whether 3.0 g mesalazine once-daily (OD) is superior to the standard treatment of 0.5 g mesalazine three times daily (t.d.s.) and to prove the therapeutic equivalence of OD vs. t.d.s. dosing of total 1.5 g mesalazine for remission maintenance in patients with ulcerative colitis. Methods A 1-year, multicentre, double-blind, double-dummy study was undertaken in patients with endoscopically and histologically confirmed ulcerative colitis in remission. Patients were randomised to oral mesalazine 3.0 g OD, 1.5 g OD or 0.5 g t.d.s. The primary efficacy endpoint was the proportion of patients still in clinical remission at the final visit, with clinical relapse being defined as CAI score >4 and an increase of â¥3 from baseline. Results The primary efficacy endpoint occurred in 162/217 3.0 g OD patients (75%), 129/212 1.5 g OD patients (61%) and 150/218 0.5 g t.d.s. patients (69%) in the intention-to-treat population, and in 152/177 (86%), 121/182 (67%) and 144/185 (78%) in the per protocol population respectively; 3.0 g OD was superior to both low-dose regimens for the primary endpoint (i.e. P <0.001, 3.0 g OD vs. 1.5 g OD; P = 0.024, 3.0 g OD vs. 0.5 g t.d.s.; superiority test, per protocol population). Safety analysis, including comprehensive renal monitoring, revealed no concern in any treatment group. Conclusion Mesalazine 3.0 g once daily was the most effective dose for maintenance of remission in ulcerative colitis of the three regimens assessed, with no penalty in terms of safety.

AB - Background Comparative data regarding different regimens of oral mesalazine (mesalamine) for maintaining remission in ulcerative colitis are limited. Aim To evaluate whether 3.0 g mesalazine once-daily (OD) is superior to the standard treatment of 0.5 g mesalazine three times daily (t.d.s.) and to prove the therapeutic equivalence of OD vs. t.d.s. dosing of total 1.5 g mesalazine for remission maintenance in patients with ulcerative colitis. Methods A 1-year, multicentre, double-blind, double-dummy study was undertaken in patients with endoscopically and histologically confirmed ulcerative colitis in remission. Patients were randomised to oral mesalazine 3.0 g OD, 1.5 g OD or 0.5 g t.d.s. The primary efficacy endpoint was the proportion of patients still in clinical remission at the final visit, with clinical relapse being defined as CAI score >4 and an increase of â¥3 from baseline. Results The primary efficacy endpoint occurred in 162/217 3.0 g OD patients (75%), 129/212 1.5 g OD patients (61%) and 150/218 0.5 g t.d.s. patients (69%) in the intention-to-treat population, and in 152/177 (86%), 121/182 (67%) and 144/185 (78%) in the per protocol population respectively; 3.0 g OD was superior to both low-dose regimens for the primary endpoint (i.e. P <0.001, 3.0 g OD vs. 1.5 g OD; P = 0.024, 3.0 g OD vs. 0.5 g t.d.s.; superiority test, per protocol population). Safety analysis, including comprehensive renal monitoring, revealed no concern in any treatment group. Conclusion Mesalazine 3.0 g once daily was the most effective dose for maintenance of remission in ulcerative colitis of the three regimens assessed, with no penalty in terms of safety.

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