Pharmacokinetics of oral hydrocortisone - Results and implications from a randomized controlled trial

Metabolism: Clinical and Experimental
Jorien Werumeus BuningAndré P van Beek

Abstract

This study aimed at comparing pharmacokinetics of two different doses of hydrocortisone (HC) in patients with secondary adrenal insufficiency (SAI). Forty-six patients with SAI participated in this randomized double-blind crossover study. Patients received two different doses of HC (0.2-0.3mg HC/kg body weight/day and 0.4-0.6mg HC/kg body weight/day). One- and two-compartment population models for plasma free cortisol, plasma total cortisol and salivary cortisol were parameterized. The individual pharmacokinetic parameters clearance (CL), volume of distribution (Vd), elimination half-life (t1/2), maximum concentration (Cmax), and area under the curve (AUC) were calculated. The one-compartment models gave a better description of the data compared to the two-compartment models. Weight-adjusted dosing reduced variability in cortisol exposure with comparable AUCs between weight groups. However, there was large inter-individual variation in CL and Vdof plasma free cortisol, plasma total cortisol and salivary cortisol. As a consequence, AUC24hvaried more than 10 fold. Cortisol exposure was increased with the higher dose, but this was dose proportional only for free cortisol concentrations and not for total cortisol. Cortisol concentr...Continue Reading

Associated Clinical Trials

Citations

Jan 31, 2020·The Journal of Clinical Endocrinology and Metabolism·Baha M Arafah
May 7, 2019·Clinical Endocrinology·Annet VultoAndré P van Beek
Aug 29, 2019·The New England Journal of Medicine·R Louise RushworthHenrik Falhammar
Jun 20, 2020·The Lancet. Diabetes & Endocrinology·Ruth L RushworthHenrik Falhammar
Nov 28, 2017·Women and Birth : Journal of the Australian College of Midwives·Sharon M YoungDaniel C Benyshek
Jun 20, 2021·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Jennifer J BonnerRichard J Ross
Nov 18, 2021·The Journal of Clinical Endocrinology and Metabolism·Mariska A M SchröderHedi L Claahsen van der Grinten

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