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Oral budesonide versus prednisolone in patients with extensive and left sided ulcerative colitis

Löfberg, Robert ; Danielsson, Åke ; Suhr, Ole ; Nilsson, Åke LU ; Schiöler, R ; Nyberg, A ; Hultcrantz, Rolf ; Kollberg, Bo ; Gillberg, Rolf and Willén, Roger , et al. (1996) In Gastroenterology 110(6). p.1713-1718
Abstract
BACKGROUND & AIMS:

Systemic glucocorticosteroids (GCSs) have proven efficacy in active ulcerative colitis but cause undesired systemic side effects. Therefore, new GCSs with high topical activity and a high rate 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 acting GCS budesonide in an oral controlled-release formulation in extensive or left-sided, mild to moderately active ulcerative colitis.

METHODS:

A 9-week, randomized, double-blind, controlled trial was performed, and treatments with 10 mg budesonide or 40 mg prednisolone daily, both gradually tapered, were compared. Endoscopic improvement and effect on endogenous... (More)
BACKGROUND & AIMS:

Systemic glucocorticosteroids (GCSs) have proven efficacy in active ulcerative colitis but cause undesired systemic side effects. Therefore, new GCSs with high topical activity and a high rate 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 acting GCS budesonide in an oral controlled-release formulation in extensive or left-sided, mild to moderately active ulcerative colitis.

METHODS:

A 9-week, randomized, double-blind, controlled trial was performed, and treatments with 10 mg budesonide or 40 mg prednisolone daily, both gradually tapered, were compared. Endoscopic improvement and effect on endogenous plasma cortisol were assessed.

RESULTS:

Thirty-four patients were administered budesonide, and 38 patients were administered prednisolone. Mean endoscopic scores improved significantly in both groups 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 Five patients in the budesonide group and 7 patients in the prednisolone group deteriorated and were withdrawn from the study.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 were suppressed in the prednisolone group (entry, 449 nmol/L; 2 weeks, 116 nmol/L; 4 weeks, 195 nmol/L) but were unchanged in the budesonide group.

CONCLUSIONS:

The GCS budesonide administered in an oral controlled-release formulation seems to give an overall treatment result in active ulcerative colitis approaching that of prednisolone but without suppression of plasma cortisol levels. This concept merits further evaluation. (Less)
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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Gastroenterology
volume
110
issue
6
pages
1713 - 1718
publisher
Elsevier
external identifiers
  • scopus:9344230405
ISSN
1528-0012
DOI
10.1053/gast.1996.v110.pm8964395
language
English
LU publication?
yes
id
2e5ff1b3-f8ef-4b87-868c-a3cd3671d850
date added to LUP
2019-05-25 08:50:49
date last changed
2024-01-04 22:26:56
@article{2e5ff1b3-f8ef-4b87-868c-a3cd3671d850,
  abstract     = {{BACKGROUND &amp; AIMS: <br>
<br>
Systemic glucocorticosteroids (GCSs) have proven efficacy in active ulcerative colitis but cause undesired systemic side effects. Therefore, new GCSs with high topical activity and a high rate 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 acting GCS budesonide in an oral controlled-release formulation in extensive or left-sided, mild to moderately active ulcerative colitis.<br>
<br>
METHODS: <br>
<br>
A 9-week, randomized, double-blind, controlled trial was performed, and treatments with 10 mg budesonide or 40 mg prednisolone daily, both gradually tapered, were compared. Endoscopic improvement and effect on endogenous plasma cortisol were assessed.<br>
<br>
RESULTS: <br>
<br>
Thirty-four patients were administered budesonide, and 38 patients were administered prednisolone. Mean endoscopic scores improved significantly in both groups 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 were suppressed in the prednisolone group (entry, 449 nmol/L; 2 weeks, 116 nmol/L; 4 weeks, 195 nmol/L) but were unchanged in the budesonide group.<br>
<br>
CONCLUSIONS: <br>
<br>
The GCS budesonide administered in an oral controlled-release formulation seems to give an overall treatment result in active ulcerative colitis approaching that of prednisolone but without suppression of plasma cortisol levels. This concept merits further evaluation.}},
  author       = {{Löfberg, Robert and Danielsson, Åke and Suhr, Ole and Nilsson, Åke and Schiöler, R and Nyberg, A and Hultcrantz, Rolf and Kollberg, Bo and Gillberg, Rolf and Willén, Roger and Persson, T and Salde, Lars}},
  issn         = {{1528-0012}},
  language     = {{eng}},
  month        = {{06}},
  number       = {{6}},
  pages        = {{1713--1718}},
  publisher    = {{Elsevier}},
  series       = {{Gastroenterology}},
  title        = {{Oral budesonide versus prednisolone in patients with extensive and left sided ulcerative colitis}},
  url          = {{http://dx.doi.org/10.1053/gast.1996.v110.pm8964395}},
  doi          = {{10.1053/gast.1996.v110.pm8964395}},
  volume       = {{110}},
  year         = {{1996}},
}