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10.1093/ecco-jcc/jjac081
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DC Field | Value | Language |
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dc.contributor.author | Kruis, Wolfgang | - |
dc.contributor.author | Siegmund, Britta | - |
dc.contributor.author | Lesniakowski, Konrad | - |
dc.contributor.author | Simanenkov, Vladimir | - |
dc.contributor.author | Khimion, Ludmila | - |
dc.contributor.author | Sobon, Marcin | - |
dc.contributor.author | Delmans, Glebs | - |
dc.contributor.author | Maksyashina, Svetlana V. | - |
dc.contributor.author | Sablin, Oleg A. | - |
dc.contributor.author | Pokrotnieks, Juris | - |
dc.contributor.author | Mostovoy, Yuriy | - |
dc.contributor.author | Datsenko, Olena | - |
dc.contributor.author | Abdulkhakov, Sayar | - |
dc.contributor.author | Dorofeyev, Andriy | - |
dc.contributor.author | Levchenko, Olena | - |
dc.contributor.author | Alexeeva, Olga | - |
dc.contributor.author | Andreev, Pavel | - |
dc.contributor.author | Kolesnik, Ivan P. | - |
dc.contributor.author | Mihaly, Emese | - |
dc.contributor.author | Abrahamovych, Orest | - |
dc.contributor.author | Baluta, Malgorzata | - |
dc.contributor.author | Kharchenko, Nataliia | - |
dc.contributor.author | Viacheslav, Neshta | - |
dc.contributor.author | Uspenskiy, Yury | - |
dc.contributor.author | Vieth, Michael | - |
dc.contributor.author | Mohrbacher, Ralf | - |
dc.contributor.author | Mueller, Ralph | - |
dc.contributor.author | Greinwald, Roland | - |
dc.date.accessioned | 2022-12-13T11:40:02Z | - |
dc.date.available | 2022-12-13T11:40:02Z | - |
dc.date.issued | 2022-11-23 | - |
dc.identifier.citation | Kruis , W , Siegmund , B , Lesniakowski , K , Simanenkov , V , Khimion , L , Sobon , M , Delmans , G , Maksyashina , S V , Sablin , O A , Pokrotnieks , J , Mostovoy , Y , Datsenko , O , Abdulkhakov , S , Dorofeyev , A , Levchenko , O , Alexeeva , O , Andreev , P , Kolesnik , I P , Mihaly , E , Abrahamovych , O , Baluta , M , Kharchenko , N , Viacheslav , N , Uspenskiy , Y , Vieth , M , Mohrbacher , R , Mueller , R & Greinwald , R 2022 , ' Novel Budesonide Suppository and Standard Budesonide Rectal Foam Induce High Rates of Clinical Remission and Mucosal Healing in Active Ulcerative Proctitis : a Randomised, Controlled, Non-inferiority Trial ' , Journal of Crohn's & Colitis , vol. 16 , no. 11 , pp. 1714-1724 . https://doi.org/10.1093/ecco-jcc/jjac081 | - |
dc.identifier.issn | 1873-9946 | - |
dc.identifier.uri | https://dspace.rsu.lv/jspui/handle/123456789/9838 | - |
dc.description | Publisher Copyright: © The Author(s) 2022. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. | - |
dc.description.abstract | BACKGROUND AND AIMS: Proctitis is the least extensive type of ulcerative colitis, for which rectal therapy is rarely studied and is underused. This study evaluated the efficacy, safety, and patient's preference of a novel formulation of budesonide suppository 4 mg, compared with a commercially available budesonide rectal foam 2 mg, for the treatment of mild to moderate ulcerative proctitis. METHODS: This was a randomised, double-blind, double-dummy, active-controlled trial. Patients were randomly assigned in a 1:1 ratio to receive either budesonide 4 mg suppository or budesonide 2 mg foam once daily for 8 weeks. The co-primary endpoints were changes from baseline to Week 8 in clinical symptoms, for which clinical remission was defined as having a modified Ulcerative Colitis-Disease Activity Index [UC-DAI] subscore for stool frequency of 0 or 1 and a subscore for rectal bleeding of 0, and mucosal healing, defined as having a modified UC-DAI subscore for mucosal appearance of 0 or 1. Using a more stringent criterion, we additionally analysed deepened mucosal healing, which was defined as a mucosal appearance subscore of 0. Patient's preference, physician's global assessment, and quality of life were also assessed and analysed. RESULTS: Overall, 286 and 291 patients were included in the 4 mg suppository and 2 mg foam groups, respectively. Budesonide 4 mg suppository met the prespecified criterion for non-inferiority to the 2 mg foam in both co-primary endpoints of clinical remission and mucosal healing. Secondary endpoints consistently supported the non-inferiority of the suppository. Trends in favour of the suppository were observed in the subgroup of mesalazine non-responders. More patients reported a preference for the suppository over rectal foam. CONCLUSIONS: In patients with ulcerative proctitis, budesonide 4 mg suppository was non-inferior to budesonide 2 mg foam in efficacy, and both were safe and well tolerated. | en |
dc.format.extent | 11 | - |
dc.format.extent | 346096 | - |
dc.language.iso | eng | - |
dc.relation.ispartof | Journal of Crohn's & Colitis | - |
dc.rights | info:eu-repo/semantics/openAccess | - |
dc.subject | budesonide | - |
dc.subject | Clinical trials | - |
dc.subject | rectal foam | - |
dc.subject | rectal suppository | - |
dc.subject | ulcerative proctitis | - |
dc.subject | 3.2 Clinical medicine | - |
dc.subject | 1.1. Scientific article indexed in Web of Science and/or Scopus database | - |
dc.subject | Gastroenterology | - |
dc.title | Novel Budesonide Suppository and Standard Budesonide Rectal Foam Induce High Rates of Clinical Remission and Mucosal Healing in Active Ulcerative Proctitis : a Randomised, Controlled, Non-inferiority Trial | en |
dc.type | /dk/atira/pure/researchoutput/researchoutputtypes/contributiontojournal/article | - |
dc.identifier.doi | 10.1093/ecco-jcc/jjac081 | - |
dc.identifier.url | http://www.scopus.com/inward/record.url?scp=85142940215&partnerID=8YFLogxK | - |
dc.description.status | Peer reviewed | - |
Appears in Collections: | Research outputs from Pure / Zinātniskās darbības rezultāti no ZDIS Pure |
Files in This Item:
File | Size | Format | |
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Novel_Budesonide_Suppository.pdf | 337.98 kB | Adobe PDF | View/Open |
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