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- W2000396029 abstract "Objectives Budesonide is a corticosteroid with low systemic bioavailability because of its high first-pass metabolism in the liver. In this paediatric, randomized, double-blind, double-dummy, controlled, multicentre trial, the safety and efficacy of budesonide versus prednisolone were evaluated in children with active Crohn's disease. Methods Forty-eight children, aged 6–16 years, with active Crohn's disease (Crohn's Disease Activity Index > 200) involving ileum and/or ascending colon were randomized to receive budesonide (9 mg/day for 8 weeks, 6 mg/day for 4 weeks) or prednisolone (1 mg/kg/day for 4 weeks, tapering for 8 weeks). Results The groups were comparable for age, sex, pubertal stage, disease activity and disease duration. Mean morning plasma cortisol concentration was significantly higher in the budesonide group (200 nmol/l) than in the prednisolone group (98 nmol/l) after 8 weeks, reflecting less adrenal suppression by budesonide (difference −102 nmol/l; 95% CI −226, −52; P = 0.0028). Glucocorticosteroid side effects such as moon face and acne occurred significantly less frequently in the budesonide group. Remission (Crohn's Disease Activity Index ≤ 150) was seen at 8 weeks in 12/22 (55%) patients treated with budesonide and in 17/24 (71%) patients receiving prednisolone (difference −16%; 95% CI −45, 13; P = 0.25). Conclusions Significantly fewer side effects and less adrenal suppression were observed in the children receiving budesonide. Remission rates were not significantly different in the two groups. However, there was a trend for prednisolone to be more effective for inducing remission." @default.
- W2000396029 created "2016-06-24" @default.
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- W2000396029 date "2004-01-01" @default.
- W2000396029 modified "2023-10-18" @default.
- W2000396029 title "Budesonide versus prednisolone for the treatment of active Crohn's disease in children" @default.
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- W2000396029 doi "https://doi.org/10.1097/00042737-200401000-00008" @default.
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