Change search
ReferencesLink to record
Permanent link

Direct link
Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomised, placebo-controlled, 12-month trial
Linkoping Univ, Fac Hlth Sci, Dept Clin & Expt Med, Div Gastroenterol & Hepatol, S-58185 Linkoping, Sweden..
Univ Orebro, Orebro Univ Hosp, Dept Gastroenterol, SE-70182 Orebro, Sweden.;Univ Orebro, Sch Hlth & Med Sci, SE-70182 Orebro, Sweden..
Ctr Digest Dis, Hamburg, Germany..
Univ Hosp, Dept Gastroenterol, Malmo, Sweden..
Show others and affiliations
2016 (English)In: Gut, ISSN 0017-5749, E-ISSN 1468-3288, Vol. 65, no 1, 47-56 p.Article in journal (Refereed) PublishedText
Abstract [en]

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.

Place, publisher, year, edition, pages
2016. Vol. 65, no 1, 47-56 p.
National Category
Gastroenterology and Hepatology
URN: urn:nbn:se:uu:diva-274273DOI: 10.1136/gutjnl-2014-308363ISI: 000366400500010OAI: diva2:912697
Available from: 2016-03-17 Created: 2016-01-20 Last updated: 2016-03-17Bibliographically approved

Open Access in DiVA

fulltext(898 kB)44 downloads
File information
File name FULLTEXT01.pdfFile size 898 kBChecksum SHA-512
Type fulltextMimetype application/pdf

Other links

Publisher's full text

Search in DiVA

By author/editor
Hellström, Per M.
By organisation
In the same journal
Gastroenterology and Hepatology

Search outside of DiVA

GoogleGoogle Scholar
Total: 44 downloads
The number of downloads is the sum of all downloads of full texts. It may include eg previous versions that are now no longer available

Altmetric score

Total: 57 hits
ReferencesLink to record
Permanent link

Direct link