Budesonide versus prednisolone retention enemas in active distal ulcerative colitis

TY - JOUR

T1 - Budesonide versus prednisolone retention enemas in active distal ulcerative colitis

AU - Löfberg, R

AU - Ostergaard Thomsen, O

AU - Langholz, E

AU - Schiöler, R

AU - Danielsson, A

AU - Suhr, O

AU - Graffner, H

AU - Påhlman, L

AU - Matzen, P

AU - Møller-Petersen, J F

PY - 1994/12

Y1 - 1994/12

N2 - METHODS: Efficacy and safety of the topically acting glucocorticosteroid budesonide retention enema (2.3 mg/115 mL) were compared with prednisolone disodium phosphate enema (31.25 mg/125 mL) in patients with active distal ulcerative colitis. The study was a randomized, multicentre trial, with two parallel groups and single-blind to the investigator. One hundred patients with active ulcerative colitis, not reaching beyond the splenic flexure as determined by endoscopy, were treated for up to 8 weeks.RESULTS: Forty-five patients were randomized to receive budesonide and 55 to prednisolone. Both treatment groups improved significantly in terms of endoscopic and histological scoring during the study, but there were no statistically significant differences between the two groups. Clinical remission, defined as no more than three daily bowel movements without blood and endoscopically non-inflamed mucosa, was achieved in 16% of the patients in the budesonide group after four weeks and in 24% in the prednisolone group (N.S.). After 8 weeks treatment the clinical remission rate in the groups had increased to 36% for budesonide and 47% for prednisolone (N.S.). Mean morning plasma cortisol levels were unchanged in the budesonide group, whereas they were significantly suppressed in the prednisolone group after 2, 4 and 8 weeks (P < 0.0001). Side effects were mild and rare in both groups.CONCLUSIONS: Treatment with budesonide enema in active distal ulcerative colitis was comparable, regarding efficacy, to treatment with conventional prednisolone enema. A prolongation of the treatment time from 4 to 8 weeks doubled the clinical remission rate in both groups. However, budesonide may be preferable to prednisolone since it causes less systemic effects as reflected by a lack of plasma cortisol suppression.

AB - METHODS: Efficacy and safety of the topically acting glucocorticosteroid budesonide retention enema (2.3 mg/115 mL) were compared with prednisolone disodium phosphate enema (31.25 mg/125 mL) in patients with active distal ulcerative colitis. The study was a randomized, multicentre trial, with two parallel groups and single-blind to the investigator. One hundred patients with active ulcerative colitis, not reaching beyond the splenic flexure as determined by endoscopy, were treated for up to 8 weeks.RESULTS: Forty-five patients were randomized to receive budesonide and 55 to prednisolone. Both treatment groups improved significantly in terms of endoscopic and histological scoring during the study, but there were no statistically significant differences between the two groups. Clinical remission, defined as no more than three daily bowel movements without blood and endoscopically non-inflamed mucosa, was achieved in 16% of the patients in the budesonide group after four weeks and in 24% in the prednisolone group (N.S.). After 8 weeks treatment the clinical remission rate in the groups had increased to 36% for budesonide and 47% for prednisolone (N.S.). Mean morning plasma cortisol levels were unchanged in the budesonide group, whereas they were significantly suppressed in the prednisolone group after 2, 4 and 8 weeks (P < 0.0001). Side effects were mild and rare in both groups.CONCLUSIONS: Treatment with budesonide enema in active distal ulcerative colitis was comparable, regarding efficacy, to treatment with conventional prednisolone enema. A prolongation of the treatment time from 4 to 8 weeks doubled the clinical remission rate in both groups. However, budesonide may be preferable to prednisolone since it causes less systemic effects as reflected by a lack of plasma cortisol suppression.

KW - Adult

KW - Anti-Inflammatory Agents/therapeutic use

KW - Budesonide

KW - Colitis, Ulcerative/drug therapy

KW - Endoscopy

KW - Enema

KW - Female

KW - Humans

KW - Hydrocortisone/blood

KW - Male

KW - Middle Aged

KW - Prednisolone/therapeutic use

KW - Pregnenediones/administration & dosage

KW - Remission Induction

M3 - Journal article

C2 - 7696452

SN - 0953-0673

VL - 8

SP - 623

EP - 629

JO - Alimentary Pharmacology and Therapeutics, Supplement

JF - Alimentary Pharmacology and Therapeutics, Supplement

IS - 6

ER -