Effect of budesonide enema on remission and relapse rate in distal ulcerative colitis and proctitis.
BACKGROUND
Glucocorticosteroid enemas are equally effective as 5-ASA enemas in the treatment of active distal ulcerative colitis (UC). With the introduction of budesonide, the risk of systemic side effects may be reduced. We investigated whether budesonide enema, 2 mg/100 ml, administered twice daily (b.i.d.) could increase the remission rate in comparison with the once daily (o.d.) standard regimen. Furthermore, we evaluated whether 2 mg budesonide enema, given twice weekly, could have a relapse preventing effect.


METHODS
149 patients with active distal UC were treated in a controlled, double-blind multicentre study with two parallel groups: placebo enema in the morning and budesonide enema in the evening (i.e. 2 mg/day) or budesonide enema b.i.d. (i.e. 4 mg/day) until remission (absence of clinical symptoms and endoscopic healing) or at most 8 weeks. Patients in remission were randomized to either budesonide enema or placebo enema twice weekly for 24 weeks or until relapse.


RESULTS
The remission rates at 4 weeks were 33% for o.d. and 41% for b.i.d. regimens (NS) and correspondingly 51% and 54% at 8 weeks (NS). The b.i.d. group had an increased frequency of impaired adrenal function, 32% versus 4.8% (P = 0.001). The relapse rates during maintenance treatment with budesonide enema and placebo were 15% versus 24% after 8 weeks, 31% versus 27% after 16 weeks and 41% versus 51% after 24 weeks (NS).


CONCLUSIONS
Budesonide enema 2 mg o.d. appears to be the optimal dosage in active distal UC. We could not show that budesonide enema twice weekly is sufficient to maintain remission.
Dept. of Medicine of University Hospital MAS, Malmö, Stockholm, Sweden. Stefan.Lindgren@medfork.mas.lu.se
S
S
Lindgren
R
R
Löfberg
L
L
Bergholm
M
M
Hellblom
L
L
Carling
K A
KA
Ung
R
R
Schiöler
P
P
Unge
C
C
Wallin
M
M
Ström
T
T
Persson
O B
OB
Suhr
D000293:Adolescent; D000328:Adult; D000368:Aged; D001707:Biopsy, Needle; D019819:Budesonide / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004733:Enema / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011349:Proctitis / Q000188:drug therapy* / Q000473:pathology; D012008:Recurrence; D012720:Severity of Illness Index; D016896:Treatment Outcome
D019819:Budesonide