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Sökning: onr:"swepub:oai:DiVA.org:oru-47352" > Low-dose budesonide...

  • 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 ...

  • 2014-11-25
  • BMJ Publishing Group,2016
  • printrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:oru-47352
  • https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-47352URI
  • https://doi.org/10.1136/gutjnl-2014-308363DOI
  • https://lup.lub.lu.se/record/4815949URI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:132594617URI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-112705URI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-274273URI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • Funding Agency:Dr Falk Pharma GmbH, Freiburg, Germany 
  • Funding agencies: Dr Falk Pharma GmbH, Freiburg, Germany
  • 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 ...)

  • 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)
  • Miehlke, StephanCentre for Digestive Disease, Hamburg, Germany,Ctr Digest Dis, Hamburg, Germany. (författare)
  • 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)
  • Olesen, MartinDepartment of Pathology, University Hospital, Malmö, Sweden,Univ Hosp, Dept Pathol, Malmo, Sweden. (författare)
  • Öst, ÅkeDepartment of Pathology and Cytology, Aleris Medilab, Täby, Sweden,Aleris Medilab, Dept Pathol & Cytol, Taby, Sweden. (författare)
  • Strandberg, LarsRegional Hospital, Falun, Sweden,Reg Hosp, Falun, Sweden. (författare)
  • Hellström, Per M.Uppsala universitet,Gastroenterologi/hepatologi(Swepub:uu)perhe742 (författare)
  • 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)
  • Armerding, PeterGastroenterology, Private Practice, Berlin, Germany (författare)
  • Stehlik, JiriDepartment of Gastroenterology, Regional Hospital, Usti nad Labem, Czech Republic,Reg Hosp, Dept Gastroenterol, Usti Nad Labem, Czech Republic. (författare)
  • Lindberg, GregerKarolinska Institutet,Karolinska University Hospital Huddinge, Stockholm, Sweden,Karolinska Univ Hosp Huddinge, Ctr Digest Dis, Stockholm, Sweden. (författare)
  • Björk, JanKarolinska Institutet,Karolinska University Hospital Solna, Stockholm, Sweden,Karolinska Univ Hosp Solna, Ctr Digest Dis, Stockholm, Sweden. (författare)
  • Lapidus, AnnikaDepartment of Gastroenterology, Ersta Hospital, Stockholm, Sweden,Ersta Hosp, Dept Gastroenterol, Stockholm, Sweden. (författare)
  • Löfberg, RobertIBD Unit, Department of Gastroenterology, Sophiahemmet, Stockholm, Sweden,Sophiahemmet, Dept Gastroenterol, IBD Unit, Stockholm, Sweden. (författare)
  • Bonderup, OleDepartment of Gastroenterology, Regional Hospital, Silkeborg, Denmark,Reg Hosp, Dept Gastroenterol, Silkeborg, Denmark. (författare)
  • Avnström, SörenDepartment of Gastroenterology, Amager Hospital, Copenhagen, Denmark,Amager Hosp, Dept Gastroenterol, Copenhagen, Denmark. (författare)
  • Rössle, MartinGastroenterology, Private Practice, Freiburg, Germany (författare)
  • Dilger, KarinDr Falk, Pharma GmBH, Freiburg, Germany (författare)
  • Mueller, RalphDr Falk, Pharma GmBH, Freiburg, Germany (författare)
  • Greinwald, RolandDr Falk, Pharma GmBH, Freiburg, Germany (författare)
  • 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)
  • 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)
  • Linköpings universitetAvdelningen för inflammationsmedicin (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:Gut: BMJ Publishing Group65:1, s. 47-560017-57491468-3288

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