ORAL BUDESONIDE VERSUS PREDNISOLONE IN PATIENTS WITH ACTIVE EXTENSIVEAND LEFT-SIDED ULCERATIVE-COLITIS

Background & Aims: Systemic glucocorticosteroids (GCSs) have proven ef ficacy in active ulcerative colitis but cause undesired systemic side effects, Therefore, new GCSs with high topical activity and a high rat e of metabolism may be of clinical value in this condition, The aim of this study was to explore the efficacy and safety of the topically ac ting GCS budesonide in an oral controlled-release formulation in exten sive or left-sided, mild to moderately active ulcerative colitis. Meth ods: A 9-week, randomized, double-blind, controlled trial was performe d, and treatments with 10 mg budesonide or 40 mg prednisolone daily, b oth gradually tapered, were compared, Endoscopic improvement and effec t on endogenous plasma cortisol were assessed. Results: Thirty-four pa tients were administered budesonide, and 38 patients were administered prednisolone, Mean endoscopic scores improved significantly in both g roups but without difference between the groups. Five patients in the budesonide group and 7 patients in the prednisolone group deteriorated and were withdrawn from the study, Morning plasma cortisol levels wer e suppressed in the prednisolone group (entry, 449 nmol/L; 2 weeks, 11 6 nmol/L; 4 weeks, 195 nmol/L) but were unchanged in the budesonide gr oup. Conclusions: The GCS budesonide administered in an oral controlle d-release formulation seems to give an overall treatment result in act ive ulcerative colitis approaching that of prednisolone but without su ppression of plasma cortisol levels, This concept merits further evalu ation.