Premium
Budesonide as maintenance treatment in Crohn's disease: a placebo‐controlled trial
Author(s) -
Hanauer S.,
Sandborn W. J.,
Persson A.,
Persson T.
Publication year - 2005
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2005.02338.x
Subject(s) - budesonide , medicine , placebo , crohn's disease , adverse effect , gastroenterology , clinical trial , surgery , corticosteroid , disease , alternative medicine , pathology
Summary Aim : To assess the efficacy and safety of budesonide capsules 6 mg daily for prolongation of time to relapse and maintenance of remission in patients with Crohn's disease (CD) affecting the ileum and/or ascending colon. Methods : In a double‐blind, placebo‐controlled, multicentre trial, 110 patients with CD, who had previously achieved remission in a placebo‐controlled trial of budesonide 9 mg daily, were randomly assigned to receive budesonide 6 mg once daily or placebo for 52 weeks. Primary outcome measure was time to relapse [CD activity index (CDAI) of >150 plus an increase of at least 60 points from study entry or withdrawal due to clinical deterioration]. Results : Median time to relapse was 360 days for budesonide patients; 169 days for placebo patients ( P = 0.132). No significant differences were seen between groups in relapse rates at 1 year. Budesonide was safe and well tolerated, with a similar adverse events profile to placebo. Conclusion : Patients treated with budesonide 6 mg once daily had a trend towards a prolonged time to relapse and lower CDAI scores compared with patients treated with placebo, but relapse rates were not significantly different at the 1‐year end point.