Low-dose budesonide for maintenance of clinical remission in collagenous colitis [Elektronisk resurs] a randomised, placebo-controlled, 12-month trial
-
Munch, Andreas (författare)
-
Bohr, Johan (författare)
-
Miehlke, Stephan (författare)
-
Benoni, Cecilia (författare)
-
Olesen, Martin (författare)
-
Ost, Ake (författare)
-
Strandberg, Lars (författare)
-
Hellström, Per M. (författare)
-
Hertervig, Erik (författare)
-
Armerding, Peter (författare)
-
Stehlik, Jiri (författare)
-
Lindberg, Greger (författare)
-
Bjork, Jan (författare)
-
Lapidus, Annika (författare)
-
Lofberg, Robert (författare)
-
Bonderup, Ole (författare)
-
Avnstrom, Soren (författare)
-
Rossle, Martin (författare)
-
Dilger, Karin (författare)
-
Mueller, Ralph (författare)
-
Greinwald, Roland (författare)
-
Tysk, Curt (författare)
-
Strom, Magnus (författare)
-
Uppsala universitet Medicinska och farmaceutiska vetenskapsområdet (utgivare)
- 2016
- Engelska.
-
Ingår i: Gut. - 0017-5749. ; 65:1, 47-56
-
Läs hela texten
-
Läs hela texten
-
Läs hela texten
Sammanfattning
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
- Medical and Health Sciences (hsv)
- Clinical Medicine (hsv)
- Gastroenterology and Hepatology (hsv)
- Medicin och hälsovetenskap (hsv)
- Klinisk medicin (hsv)
- Gastroenterologi (hsv)
Inställningar
Hjälp
Beståndsinformation saknas