Oral budesonide is as effective as oral prednisolone in active Crohn's disease. The Global Budesonide Study Group.
BACKGROUND
The use of corticosteroids in active Crohn's disease often becomes limited by side effects. Budesonide is a potent corticosteroid with low systemic bioavailability due to an extensive first pass liver metabolism.


OBJECTIVE
To compare the efficacy and safety of two dosage regimens of budesonide and prednisolone in patients with active Crohn's disease affecting the ileum and/or the ascending colon.


METHODS
One hundred and seventy eight patients were randomised to receive budesonide controlled ileal release (CIR) capsules 9 mg once daily or 4.5 mg twice daily, or prednisolone tablets 40 mg once daily. The treatment period was 12 weeks. The primary efficacy variable was clinical remission, defined as a Crohn's Disease Activity Index (CDAI) of 150 or less.


RESULTS
After eight weeks of treatment, remission occurred in 60% of patients receiving budesonide once daily or prednisolone and in 42% of those receiving budesonide twice daily (p = 0.062). The presence of glucocorticoid associated side effects was similar in all groups; however, moon face was more common in the prednisolone group (p = 0.0005). The highest frequency of impaired adrenal function, as measured by a short ACTH test, was found in the prednisolone group (p = 0.0023).


CONCLUSIONS
Budesonide CIR, administered at 9 mg once daily or 4.5 mg twice daily, is comparable to prednisolone in inducing remission in active Crohn's disease. The single dose administration is as promptly effective as prednisolone and represents a simpler and safer therapeutic approach, with a considerable reduction in side effects.
Campieri
M
M
Medical and Gastroenterological Clinic, University of Bologna, Italy.
Ferguson
A
A
Doe
W
W
Persson
T
T
Nilsson
L G
LG
D000208:Acute Disease; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D019819:Budesonide; D003092:Colitis / Q000188:drug therapy; D003424:Crohn Disease / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D007079:Ileitis / Q000188:drug therapy; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000009:adverse effects / Q000627:therapeutic use*; D011282:Pregnenediones / Q000009:adverse effects / Q000627:therapeutic use*
D000893:Anti-Inflammatory Agents; D003692:Delayed-Action Preparations; D011282:Pregnenediones; D019819:Budesonide; D011239:Prednisolone; D006854:Hydrocortisone