Abstract
BACKGROUND AND AIMS: To evaluate the efficacy and safety of the topical corticosteroid budesonide, given in an oral controlled release formulation for maintenance of remission in patients with ileal and ileocaecal Crohn's disease (CD). PATIENTS AND METHODS: Out of 176 patients with active CD who had achieved remission (CD activity index score < or = 150) after 10 weeks' treatment with either budesonide or prednisolone, 90 were randomised to continue with once daily treatment of 6 mg budesonide, or 3 mg budesonide or placebo for up to 12 months in a double blind, multicentre trial. Time to symptomatic relapse was calculated using Kaplan-Meier estimates. Morning plasma cortisol was measured at clinic visits and a corticotropin stimulation test was performed after three months of treatment. RESULTS: Thirty two patients were allocated to the 6 mg budesonide group, 31 to the 3 mg group, and 27 to the placebo group. After three months, 19 per cent of the patients in the 6 mg group had relapsed, compared with 45 per cent in the 3 mg group and 44 per cent in the placebo group (p = 0.047). The corresponding results after 12 months was 59 per cent in the 6 mg budesonide group, 74 per cent in the 3 mg group, and 63 per cent in the placebo group (p = 0.44). The median time to relapse or discontinuation was 258 days in the 6 mg group, 139 days in the 3 mg group, and 92 days in the placebo group (p = 0.021). Mean morning plasma cortisol values increased from entry in all three groups with no statistically significant differences at 12 months. All 13 patients remaining in the placebo group after three months had a normal corticotropin stimulation response, compared with 18 of 23 patients in the 6 mg, and 19 of 21 in the 3 mg budesonide groups (p = 0.14). Acne and moon face were slightly more common in the budesonide groups. CONCLUSION: 6 mg budesonide once daily is significantly more efficacious than placebo in prolonging time to relapse in CD, and causes only minor systemic side effects.
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- Christy N. P. Pituitary-adrenal function during corticosteroid therapy. Learning to live with uncertainty. N Engl J Med. 1992 Jan 23;326(4):266–267. doi: 10.1056/NEJM199201233260410. [DOI] [PubMed] [Google Scholar]
- Greenberg G. R., Feagan B. G., Martin F., Sutherland L. R., Thomson A. B., Williams C. N., Nilsson L. G., Persson T. Oral budesonide for active Crohn's disease. Canadian Inflammatory Bowel Disease Study Group. N Engl J Med. 1994 Sep 29;331(13):836–841. doi: 10.1056/NEJM199409293311303. [DOI] [PubMed] [Google Scholar]
- Löfberg R., Ostergaard Thomsen O., Langholz E., Schiöler R., Danielsson A., Suhr O., Graffner H., Påhlman L., Matzen P., Møller-Petersen J. F. Budesonide versus prednisolone retention enemas in active distal ulcerative colitis. Aliment Pharmacol Ther. 1994 Dec;8(6):623–629. doi: 10.1111/j.1365-2036.1994.tb00340.x. [DOI] [PubMed] [Google Scholar]
- Malchow H., Ewe K., Brandes J. W., Goebell H., Ehms H., Sommer H., Jesdinsky H. European Cooperative Crohn's Disease Study (ECCDS): results of drug treatment. Gastroenterology. 1984 Feb;86(2):249–266. [PubMed] [Google Scholar]
- Meyers S., Sachar D. B. Medical management of Crohn's disease. Hepatogastroenterology. 1990 Feb;37(1):42–55. [PubMed] [Google Scholar]
- Munkholm P., Langholz E., Davidsen M., Binder V. Frequency of glucocorticoid resistance and dependency in Crohn's disease. Gut. 1994 Mar;35(3):360–362. doi: 10.1136/gut.35.3.360. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Rutgeerts P., Löfberg R., Malchow H., Lamers C., Olaison G., Jewell D., Danielsson A., Goebell H., Thomsen O. O., Lorenz-Meyer H. A comparison of budesonide with prednisolone for active Crohn's disease. N Engl J Med. 1994 Sep 29;331(13):842–845. doi: 10.1056/NEJM199409293311304. [DOI] [PubMed] [Google Scholar]
- Summers R. W., Switz D. M., Sessions J. T., Jr, Becktel J. M., Best W. R., Kern F., Jr, Singleton J. W. National Cooperative Crohn's Disease Study: results of drug treatment. Gastroenterology. 1979 Oct;77(4 Pt 2):847–869. [PubMed] [Google Scholar]
- van den Berg J. H., Mol C. R., Deelder R. S., Thijssen J. H. A quantitative assay of cortisol in human plasma by high performance liquid chromatography using a selective chemically bonded stationary phase. Clin Chim Acta. 1977 Jul 15;78(2):165–172. doi: 10.1016/0009-8981(77)90303-5. [DOI] [PubMed] [Google Scholar]