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Low-dose budesonide...
Low-dose budesonide for maintenance of clinical remission in collagenous colitis : a randomised, placebo-controlled, 12-month trial
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- Münch, Andreas (author)
- 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.
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- Bohr, Johan, 1957- (author)
- 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.
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- Miehlke, Stephan (author)
- Centre for Digestive Disease, Hamburg, Germany,Ctr Digest Dis, Hamburg, Germany.
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- Benoni, Cecilia (author)
- 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.
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- Olesen, Martin (author)
- Department of Pathology, University Hospital, Malmö, Sweden,Univ Hosp, Dept Pathol, Malmo, Sweden.
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- Öst, Åke (author)
- Department of Pathology and Cytology, Aleris Medilab, Täby, Sweden,Aleris Medilab, Dept Pathol & Cytol, Taby, Sweden.
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- Strandberg, Lars (author)
- Regional Hospital, Falun, Sweden,Reg Hosp, Falun, Sweden.
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- Hellström, Per M. (author)
- Uppsala universitet,Gastroenterologi/hepatologi
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- Hertervig, Erik (author)
- 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.
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- Armerding, Peter (author)
- Gastroenterology, Private Practice, Berlin, Germany
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- Stehlik, Jiri (author)
- Department of Gastroenterology, Regional Hospital, Usti nad Labem, Czech Republic,Reg Hosp, Dept Gastroenterol, Usti Nad Labem, Czech Republic.
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- Lindberg, Greger (author)
- Karolinska Institutet,Karolinska University Hospital Huddinge, Stockholm, Sweden,Karolinska Univ Hosp Huddinge, Ctr Digest Dis, Stockholm, Sweden.
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- Björk, Jan (author)
- Karolinska Institutet,Karolinska University Hospital Solna, Stockholm, Sweden,Karolinska Univ Hosp Solna, Ctr Digest Dis, Stockholm, Sweden.
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- Lapidus, Annika (author)
- Department of Gastroenterology, Ersta Hospital, Stockholm, Sweden,Ersta Hosp, Dept Gastroenterol, Stockholm, Sweden.
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- Löfberg, Robert (author)
- IBD Unit, Department of Gastroenterology, Sophiahemmet, Stockholm, Sweden,Sophiahemmet, Dept Gastroenterol, IBD Unit, Stockholm, Sweden.
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- Bonderup, Ole (author)
- Department of Gastroenterology, Regional Hospital, Silkeborg, Denmark,Reg Hosp, Dept Gastroenterol, Silkeborg, Denmark.
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- Avnström, Sören (author)
- Department of Gastroenterology, Amager Hospital, Copenhagen, Denmark,Amager Hosp, Dept Gastroenterol, Copenhagen, Denmark.
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- Rössle, Martin (author)
- Gastroenterology, Private Practice, Freiburg, Germany
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- Dilger, Karin (author)
- Dr Falk, Pharma GmBH, Freiburg, Germany
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- Mueller, Ralph (author)
- Dr Falk, Pharma GmBH, Freiburg, Germany
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- Greinwald, Roland (author)
- Dr Falk, Pharma GmBH, Freiburg, Germany
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- Tysk, Curt, 1949- (author)
- 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.
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- Ström, Magnus (author)
- 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
- English.
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In: Gut. - : BMJ Publishing Group. - 0017-5749 .- 1468-3288. ; 65:1, s. 47-56
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Abstract
Subject headings
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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.
Subject headings
- 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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- art (subject category)
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Gut
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- By the author/editor
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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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show more...
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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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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Gastroenterology ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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Gut
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Örebro University
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Lund University
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Karolinska Institutet
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Linköping University
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Uppsala University