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Low-dose budesonide for maintenance of clinical remission in collagenous colitis : a randomised, placebo-controlled, 12-month trial

Münch, Andreas (författare)
Östergötlands 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.
Bohr, Johan, 1957- (författare)
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.
Miehlke, Stephan (författare)
Centre for Digestive Disease, Hamburg, Germany,Ctr Digest Dis, Hamburg, Germany.
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Benoni, Cecilia (författare)
Lund 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.
Olesen, Martin (författare)
Department of Pathology, University Hospital, Malmö, Sweden,Univ Hosp, Dept Pathol, Malmo, Sweden.
Öst, Åke (författare)
Department of Pathology and Cytology, Aleris Medilab, Täby, Sweden,Aleris Medilab, Dept Pathol & Cytol, Taby, Sweden.
Strandberg, Lars (författare)
Regional Hospital, Falun, Sweden,Reg Hosp, Falun, Sweden.
Hellström, Per M. (författare)
Uppsala universitet,Gastroenterologi/hepatologi
Hertervig, Erik (författare)
Lund 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.
Armerding, Peter (författare)
Gastroenterology, Private Practice, Berlin, Germany
Stehlik, Jiri (författare)
Department of Gastroenterology, Regional Hospital, Usti nad Labem, Czech Republic,Reg Hosp, Dept Gastroenterol, Usti Nad Labem, Czech Republic.
Lindberg, Greger (författare)
Karolinska Institutet,Karolinska University Hospital Huddinge, Stockholm, Sweden,Karolinska Univ Hosp Huddinge, Ctr Digest Dis, Stockholm, Sweden.
Björk, Jan (författare)
Karolinska Institutet,Karolinska University Hospital Solna, Stockholm, Sweden,Karolinska Univ Hosp Solna, Ctr Digest Dis, Stockholm, Sweden.
Lapidus, Annika (författare)
Department of Gastroenterology, Ersta Hospital, Stockholm, Sweden,Ersta Hosp, Dept Gastroenterol, Stockholm, Sweden.
Löfberg, Robert (författare)
IBD Unit, Department of Gastroenterology, Sophiahemmet, Stockholm, Sweden,Sophiahemmet, Dept Gastroenterol, IBD Unit, Stockholm, Sweden.
Bonderup, Ole (författare)
Department of Gastroenterology, Regional Hospital, Silkeborg, Denmark,Reg Hosp, Dept Gastroenterol, Silkeborg, Denmark.
Avnström, Sören (författare)
Department of Gastroenterology, Amager Hospital, Copenhagen, Denmark,Amager Hosp, Dept Gastroenterol, Copenhagen, Denmark.
Rössle, Martin (författare)
Gastroenterology, Private Practice, Freiburg, Germany
Dilger, Karin (författare)
Dr Falk, Pharma GmBH, Freiburg, Germany
Mueller, Ralph (författare)
Dr Falk, Pharma GmBH, Freiburg, Germany
Greinwald, Roland (författare)
Dr Falk, Pharma GmBH, Freiburg, Germany
Tysk, Curt, 1949- (författare)
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.
Ström, Magnus (författare)
Linköpings 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.
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 (creator_code:org_t)
2014-11-25
2016
Engelska.
Ingår i: Gut. - : BMJ Publishing Group. - 0017-5749 .- 1468-3288. ; 65:1, s. 47-56
Relaterad länk:
https://doi.org/10.1...
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http://www.ncbi.nlm....
http://dx.doi.org/10...
https://uu.diva-port... (primary) (Raw object)
https://urn.kb.se/re...
https://doi.org/10.1...
https://lup.lub.lu.s...
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  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
Stäng  
  • 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

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Gastroenterologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Gastroenterology and Hepatology (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine (hsv//eng)

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