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Oral budesonide therapy for steroid‐dependent ulcerative colitis: a pilot trial
Author(s) -
KELLER R.,
STOLL R.,
FOERSTER E. C.,
GUTSCHE N.,
DOMSCHKE W.
Publication year - 1997
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 - 10.1046/j.1365-2036.1997.00263.x
Subject(s) - budesonide , medicine , ulcerative colitis , corticosteroid , gastroenterology , colitis , disease
Background: Budesonide, a corticosteroid with high topical anti‐inflammatory activity and low systemic activity, has been shown to prolong time to relapse in Crohn's disease. In the present study, the efficacy of budesonide in an oral pH‐modified‐release formulation was evaluated for maintenance treatment in patients with steroid‐dependent ulcerative colitis. Methods: Fourteen patients with steroid‐dependent ulcerative colitis in the reduction phase of conventional glucocorticosteroids (c‐GCS) following a severe attack, were treated with budesonide 3 mg t.d.s. for 6 months. The primary investigation parameters were changes in the clinical activity index (CAI) and in the daily dose of c‐GCS. Results: In 11 cases the CAI improved significantly and treatment with c‐GCS could be terminated. Three patients experienced relapse and needed further c‐GCS treatment. The average daily dose of c‐GCS and the average value of the CAI before treatment with budesonide were significantly higher in the relapse group than in the remission group. Conclusions: In patients with c‐GCS‐dependent ulcerative colitis, a dose of 9 mg budesonide daily in an oral pH‐modified‐release formulation was well tolerated, significantly decreased the CAI, and rendered c‐GCS unnecessary in the majority of cases.