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A randomized controlled assessment of the effects of different dosing regimens of budesonide on the HPA‐axis in healthy subjects
Author(s) -
Andersson Norma,
Källén Anders,
Thorsson Lars
Publication year - 2001
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1046/j.1365-2125.2001.01353.x
Subject(s) - evening , morning , budesonide , placebo , medicine , crossover study , dosing , corticosteroid , anesthesia , alternative medicine , pathology , physics , astronomy
Aims To investigate the effect on the hypothalamo‐pituitary‐adrenal (HPA) axis of treatment with budesonide, 400 µg once daily, morning or evening, or 200 µg twice daily, and 800 µg twice daily via Turbuhaler in a randomized, placebo‐controlled, double‐blind, double‐dummy crossover study. Methods Healthy men received budesonide, 400 µg in the morning (08.00–09.00 h) or evening (20.00–21.00 h), budesonide, 200 µg twice daily, 800 µg twice daily, and placebo twice daily, for 1 week each. Plasma and urine samples were obtained over 24 h on day 7 for cortisol determination. Twenty‐five subjects completed all treatments, and 27 were included in the analysis. Results The 24 h plasma cortisol concentrations vs placebo (95% CI) were 98% (89, 108) for 400 µg in the morning, 92% (83, 100) for 400 µg in the evening, 95% (86, 104) for 200 µg twice daily, and 76% (70, 84) for 800 µg twice daily. Conclusions Budesonide at a dose of 400 µg day −1 via Turbuhaler had no statistically significant effect on 24 h cortisol production, irrespective of whether treatment is given once or twice daily, whereas a dose of 800 µg twice daily resulted in a statistically significant suppression vs placebo. Neither could a significant difference be found between morning and evening dosing.