Please use this identifier to cite or link to this item:
10.1111/j.1365-2036.2010.04537.x
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DC Field | Value | Language |
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dc.contributor.author | Kruis, W. | - |
dc.contributor.author | Jonaitis, L. | - |
dc.contributor.author | Pokrotnieks, J. | - |
dc.contributor.author | Mikhailova, T. L. | - |
dc.contributor.author | Horynski, M. | - |
dc.contributor.author | Bátovskã, M. | - |
dc.contributor.author | Lozynsky, Y. S. | - |
dc.contributor.author | Zakharash, Y. | - |
dc.contributor.author | Rácz, I. | - |
dc.contributor.author | Kull, K. | - |
dc.contributor.author | Vcev, A. | - |
dc.contributor.author | Faszczyk, M. | - |
dc.contributor.author | Dilger, K. | - |
dc.contributor.author | Greinwald, R. | - |
dc.contributor.author | Mueller, R. | - |
dc.date.accessioned | 2021-11-15T14:00:01Z | - |
dc.date.available | 2021-11-15T14:00:01Z | - |
dc.date.issued | 2011-02 | - |
dc.identifier.citation | 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 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 | - |
dc.identifier.issn | 0269-2813 | - |
dc.identifier.uri | https://dspace.rsu.lv/jspui/handle/123456789/6825 | - |
dc.description.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. | en |
dc.format.extent | 10 | - |
dc.format.extent | 262324 | - |
dc.language.iso | eng | - |
dc.relation.ispartof | Alimentary Pharmacology and Therapeutics | - |
dc.rights | info:eu-repo/semantics/openAccess | - |
dc.subject | 3.2 Clinical medicine | - |
dc.subject | 3.1 Basic medicine | - |
dc.subject | 1.1. Scientific article indexed in Web of Science and/or Scopus database | - |
dc.subject | Hepatology | - |
dc.subject | Gastroenterology | - |
dc.subject | Pharmacology (medical) | - |
dc.title | Randomised clinical trial : A comparative dose-finding study of three arms of dual release mesalazine for maintaining remission in ulcerative colitis | en |
dc.type | /dk/atira/pure/researchoutput/researchoutputtypes/contributiontojournal/article | - |
dc.identifier.doi | 10.1111/j.1365-2036.2010.04537.x | - |
dc.identifier.url | http://www.scopus.com/inward/record.url?scp=78650879471&partnerID=8YFLogxK | - |
dc.description.status | Peer reviewed | - |
Appears in Collections: | Research outputs from Pure / Zinātniskās darbības rezultāti no ZDIS Pure |
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Randomised_clinical_trial.pdf | 256.18 kB | Adobe PDF | View/Open![]() |
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