Post Details page

Low-dose Budosenide Helps in Maintenance of Clinical Remission in Collagenous Colitis

270 views View

4
shares
Share on Facebook
Share on Twitter
Share on Google+
Share on LinkedIn
Pin to Pinterest
Share on StumbleUpon
+
What's This?

Low-dose Budosenide Helps in Maintenance of Clinical Remission in Collagenous Colitis

OBJECTIVE:

To assess low-dose budesonide therapy on the 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.

REFERENCE:

Andreas Münch et al. Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomized, placebo-controlled, 12-month trial. 2016 Jan; 65(1):47-56

Available at: http://www.ncbi.nlm.nih.gov/pubmed/25425655/

Share on Facebook
Share on Twitter
Share on Google+
Share on LinkedIn
Pin to Pinterest
Share on StumbleUpon
+

Leave a Reply

Your email address will not be published. Required fields are marked *




Login


Username
Create an Account!
Password
Forgot Password? (close)

Create an Account!


Username
Email
Password
Confirm Password
Want to Login? (close)

forgot password?


Username or Email
(close)




or Sign in direct

Sign up for VideoCafe Account