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A cortisol suppression dose–response comparison of budesonide in controlled ileal release capsules with prednisolone
Author(s) -
Staffan Edsbäcker,
Maj-Inger Nilsson,
Petter Larsson
Publication year - 1999
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.1999.00472.x
Subject(s) - budesonide , prednisolone , medicine , urine , placebo , endocrinology , corticosteroid , crossover study , hydrocortisone , area under the curve , glucocorticoid , excretion , alternative medicine , pathology
Aim: To assess the systemic effect of oral budesonide, given as Entocort controlled ileal release capsules, over a dose range of 3–15 mg/day, compared with that of a moderate dose (20 mg/day) of prednisolone. Methods: Twenty four healthy subjects were given 3, 9 or 15 mg budesonide or 20 mg prednisolone once daily, or 4.5 mg budesonide b.d., or placebo for 5 days in a randomized, double‐blind crossover study. The area under the curve ( AUC ) of plasma cortisol concentration and the amount of cortisol excreted in the urine were monitored. Results: Both plasma and urine cortisol suppression showed a dose‐response for the daily doses of budesonide. Prednisolone, 20 mg, suppressed plasma cortisol ( AUC ) statistically significantly more than 15 mg budesonide ( P = 0.014), and 3 mg budesonide statistically significantly more than placebo ( P = 0.010). No difference in AUC was detected between 9 mg and 4.5 mg budesonide b.d. Similar results for budesonide vs. placebo were obtained from urine cortisol excretion data. However, prednisolone affected urine cortisol less than it affected plasma cortisol. Conclusion After 5 days of administration, budesonide controlled ileal release capsules, in both clinical (9 mg/day) and high doses (15 mg/day), affected plasma cortisol less than a moderate (20 mg/day) dose of prednisolone.