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Low-dose budesonide...
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Münch, AndreasÖstergötlands Läns Landsting,Linköpings universitet,Avdelningen för inflammationsmedicin,Hälsouniversitetet,Magtarmmedicinska kliniken,Linkoping Univ, Fac Hlth Sci, Dept Clin & Expt Med, Div Gastroenterol & Hepatol, S-58185 Linkoping, Sweden.
(författare)
Low-dose budesonide for maintenance of clinical remission in collagenous colitis : a randomised, placebo-controlled, 12-month trial
- Artikel/kapitelEngelska2016
Förlag, utgivningsår, omfång ...
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2014-11-25
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BMJ Publishing Group,2016
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printrdacarrier
Nummerbeteckningar
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LIBRIS-ID:oai:DiVA.org:oru-47352
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https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-47352URI
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https://doi.org/10.1136/gutjnl-2014-308363DOI
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https://lup.lub.lu.se/record/4815949URI
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http://kipublications.ki.se/Default.aspx?queryparsed=id:132594617URI
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https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-112705URI
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https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-274273URI
Kompletterande språkuppgifter
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Språk:engelska
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Sammanfattning på:engelska
Ingår i deldatabas
Klassifikation
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Ämneskategori:ref swepub-contenttype
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Ämneskategori:art swepub-publicationtype
Anmärkningar
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Funding Agency:Dr Falk Pharma GmbH, Freiburg, Germany
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Funding agencies: Dr Falk Pharma GmbH, Freiburg, Germany
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Objective: This 1-year study aimed to assess low-dose budesonide therapy for maintenance of clinical remission in patients with collagenous colitis.Design: A prospective, randomised, placebo-controlled study beginning with an 8-week open-label induction phase in which patients with histologically confirmed active collagenous colitis received budesonide (Budenofalk, 9 mg/day initially, tapered to 4.5 mg/day), after which 92 patients in clinical remission were randomised to budesonide (mean dose 4.5 mg/day; Budenofalk 3 mg capsules, two or one capsule on alternate days) or placebo in a 12-month double-blind phase with 6 months treatment-free follow-up. Primary endpoint was clinical remission throughout the double-blind phase.Results: Clinical remission during open-label treatment was achieved by 84.5% (93/110 patients). The median time to remission was 10.5 days (95% CI (9.0 to 14.0 days)). The maintenance of clinical remission at 1 year was achieved by 61.4% (27/44 patients) in the budesonide group versus 16.7% (8/48 patients) receiving placebo (treatment difference 44.5% in favour of budesonide; 95% CI (26.9% to 62.7%), p<0.001). Health-related quality of life was maintained during the 12-month double-blind phase in budesonide-treated patients. During treatment-free follow-up, 82.1% (23/28 patients) formerly receiving budesonide relapsed after study drug discontinuation. Low-dose budesonide over 1 year resulted in few suspected adverse drug reactions (7/44 patients), all non-serious.Conclusions: Budesonide at a mean dose of 4.5 mg/day maintained clinical remission for at least 1 year in the majority of patients with collagenous colitis and preserved health-related quality of life without safety concerns. Treatment extension with low-dose budesonide beyond 1 year may be beneficial given the high relapse rate after budesonide discontinuation.
Ämnesord och genrebeteckningar
Biuppslag (personer, institutioner, konferenser, titlar ...)
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Bohr, Johan,1957-Region Örebro län,Department of Gastroenterology, Örebro University Hospital, Örebro, Sweden,Örebro University Hospital, and School of Health and Medical Sciences, Örebro University, Sweden,Univ Orebro, Orebro Univ Hosp, Dept Gastroenterol, SE-70182 Orebro, Sweden.;Univ Orebro, Sch Hlth & Med Sci, SE-70182 Orebro, Sweden.(Swepub:oru)jbr
(författare)
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Miehlke, StephanCentre for Digestive Disease, Hamburg, Germany,Ctr Digest Dis, Hamburg, Germany.
(författare)
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Benoni, CeciliaLund University,Lunds universitet,Anestesiologi och intensivvård,Forskargrupper vid Lunds universitet,Anaesthesiology and Intensive Care Medicine,Lund University Research Groups,University Hospital, Malmö, Sweden,Univ Hosp, Dept Gastroenterol, Malmo, Sweden.(Swepub:lu)medf-cbe
(författare)
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Olesen, MartinDepartment of Pathology, University Hospital, Malmö, Sweden,Univ Hosp, Dept Pathol, Malmo, Sweden.
(författare)
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Öst, ÅkeDepartment of Pathology and Cytology, Aleris Medilab, Täby, Sweden,Aleris Medilab, Dept Pathol & Cytol, Taby, Sweden.
(författare)
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Strandberg, LarsRegional Hospital, Falun, Sweden,Reg Hosp, Falun, Sweden.
(författare)
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Hellström, Per M.Uppsala universitet,Gastroenterologi/hepatologi(Swepub:uu)perhe742
(författare)
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Hertervig, ErikLund University,Lunds universitet,Medicin, Lund,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Medicine, Lund,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,University Hospital, Lund, Sweden,Univ Lund Hosp, Dept Gastroenterol, S-22185 Lund, Sweden.(Swepub:lu)med-ehe
(författare)
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Armerding, PeterGastroenterology, Private Practice, Berlin, Germany
(författare)
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Stehlik, JiriDepartment of Gastroenterology, Regional Hospital, Usti nad Labem, Czech Republic,Reg Hosp, Dept Gastroenterol, Usti Nad Labem, Czech Republic.
(författare)
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Lindberg, GregerKarolinska Institutet,Karolinska University Hospital Huddinge, Stockholm, Sweden,Karolinska Univ Hosp Huddinge, Ctr Digest Dis, Stockholm, Sweden.
(författare)
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Björk, JanKarolinska Institutet,Karolinska University Hospital Solna, Stockholm, Sweden,Karolinska Univ Hosp Solna, Ctr Digest Dis, Stockholm, Sweden.
(författare)
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Lapidus, AnnikaDepartment of Gastroenterology, Ersta Hospital, Stockholm, Sweden,Ersta Hosp, Dept Gastroenterol, Stockholm, Sweden.
(författare)
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Löfberg, RobertIBD Unit, Department of Gastroenterology, Sophiahemmet, Stockholm, Sweden,Sophiahemmet, Dept Gastroenterol, IBD Unit, Stockholm, Sweden.
(författare)
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Bonderup, OleDepartment of Gastroenterology, Regional Hospital, Silkeborg, Denmark,Reg Hosp, Dept Gastroenterol, Silkeborg, Denmark.
(författare)
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Avnström, SörenDepartment of Gastroenterology, Amager Hospital, Copenhagen, Denmark,Amager Hosp, Dept Gastroenterol, Copenhagen, Denmark.
(författare)
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Rössle, MartinGastroenterology, Private Practice, Freiburg, Germany
(författare)
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Dilger, KarinDr Falk, Pharma GmBH, Freiburg, Germany
(författare)
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Mueller, RalphDr Falk, Pharma GmBH, Freiburg, Germany
(författare)
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Greinwald, RolandDr Falk, Pharma GmBH, Freiburg, Germany
(författare)
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Tysk, Curt,1949-Region Örebro län,Department of Gastroenterology, Örebro University Hospital, Örebro, Sweden,Örebro University Hospital, and School of Health and Medical Sciences, Örebro University, Sweden,Univ Orebro, Orebro Univ Hosp, Dept Gastroenterol, SE-70182 Orebro, Sweden.;Univ Orebro, Sch Hlth & Med Sci, SE-70182 Orebro, Sweden.(Swepub:oru)ctk
(författare)
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Ström, MagnusLinköpings universitet,Östergötlands Läns Landsting,Magtarmmedicinska kliniken,Avdelningen för neuro- och inflammationsvetenskap,Medicinska fakulteten,Linkoping Univ, Fac Hlth Sci, Dept Clin & Expt Med, Div Gastroenterol & Hepatol, S-58185 Linkoping, Sweden.(Swepub:liu)magst47
(författare)
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Linköpings universitetAvdelningen för inflammationsmedicin
(creator_code:org_t)
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Ingår i:Gut: BMJ Publishing Group65:1, s. 47-560017-57491468-3288
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Münch, Andreas
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Bohr, Johan, 195 ...
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Miehlke, Stephan
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Benoni, Cecilia
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Olesen, Martin
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Öst, Åke
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visa fler...
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Strandberg, Lars
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Hellström, Per M ...
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Hertervig, Erik
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Armerding, Peter
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Stehlik, Jiri
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Lindberg, Greger
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Björk, Jan
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Lapidus, Annika
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Löfberg, Robert
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Bonderup, Ole
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Avnström, Sören
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Rössle, Martin
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Dilger, Karin
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Mueller, Ralph
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Greinwald, Rolan ...
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Tysk, Curt, 1949 ...
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Ström, Magnus
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