Oral budesonide therapy for steroid-dependent ulcerative colitis: a pilot trial.
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.
Keller
R
R
Department of Medicine B, University of Münster, Germany.
Stoll
R
R
Foerster
E C
EC
Gutsche
N
N
Domschke
W
W
D000284:Administration, Oral; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D019819:Budesonide / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D005260:Female; D005938:Glucocorticoids; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D013256:Steroids / Q000009:adverse effects*; D019966:Substance-Related Disorders
D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D013256:Steroids; D019819:Budesonide