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

A. Münch, J. Bohr, S. Miehlke, C. Benoni, M. Olesen, Å. Öst, L. Strandberg, PM. Hellström, E. Hertervig, P. Armerding, J. Stehlik, G. Lindberg, J. Björk, A. Lapidus, R. Löfberg, O. Bonderup, S. Avnström, M. Rössle, K. Dilger, R. Mueller, R....

. 2016 ; 65 (1) : 47-56. [pub] 20141125

Language English Country England, Great Britain

Document type Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc16021031
E-resources Online Full text

NLK ProQuest Central from 1960-03-01 to 6 months ago
Health & Medicine (ProQuest) from 1960-03-01 to 6 months ago

Links

PubMed 25425655
DOI 10.1136/gutjnl-2014-308363
Knihovny.cz E-resources

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. TRIAL REGISTRATION NUMBERS: http://www.clinicaltrials.gov (NCT01278082) and http://www.clinicaltrialsregister.eu (EudraCT: 2007-001315-31).

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$a Bohr, Johan $u Department of Gastroenterology, Örebro University Hospital, and School of Health and Medical Sciences, Örebro University, Örebro, Sweden.
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$a Lapidus, Annika $u Department of Gastroenterology, Ersta Hospital, Stockholm, Sweden.
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