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

Löfberg, Robert (author)
Karolinska Institutet
Danielsson, Åke (author)
Umeå University
Suhr, Ole (author)
Umeå University
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Nilsson, Åke (author)
Lund University,Lunds universitet,Medicin, Lund,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Gastro,Forskargrupper vid Lunds universitet,Medicine, Lund,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Lund University Research Groups
Schiöler, R (author)
Nyberg, A (author)
Hultcrantz, Rolf (author)
Karolinska Institutet,Karolinska University Hospital
Kollberg, Bo (author)
Gillberg, Rolf (author)
Willén, Roger (author)
Persson, T (author)
Salde, Lars (author)
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 (creator_code:org_t)
Elsevier BV, 1996
1996
English.
In: Gastroenterology. - : Elsevier BV. - 1528-0012 .- 0016-5085. ; 110:6, s. 1713-1718
  • Journal article (peer-reviewed)
Abstract Subject headings
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  • 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 Five patients in the budesonide group and 7 patients in the prednisolone group deteriorated and were withdrawn from the study.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.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Gastroenterologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Gastroenterology and Hepatology (hsv//eng)

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