Subcutaneous hydrocortisone administration for emergency use in adrenal insufficiency

Abstract

Objective: Evaluation of the pharmacokinetics and safety of s.c. hydrocortisone injection for use in adrenal emergency. Design: Single-center, open-label, sequence-randomized, crossover study in a tertiary care center. Patients and methods: Twelve patients with chronic Addison's disease. Comparison of hydrocortisone pharmacokinetics after s.c. and i.m. injection (100 mg) and after s.c. administration of sodium chloride (0.9%) respectively at three different visits. Main outcome measure: maximum serum cortisol (Cmax), time to Cmax (tmax), and time to serum cortisolO36 mg/dl (tserum cortisol O36 mg/dl) after s.c. administration compared with i.m. administration, safety, and patient preference. Results: Serum cortisol increased rapidly and substantially after both i.m. and s.c. injections (Cmax: 110G29 vs 97G28 mg/dl, PZ0.27, tmax: 66G51 vs 91G34 min, PZ0.17, and tserum cortisol O 36 mg/dl: 11G5 vs 22G11 min, PZ0.004 respectively). Both i.m. and s.c. injections were well tolerated. Eleven (91.7%) patients preferred s.c. injection, whereas one patient did not have any preference. Conclusions: S.c. administration of 100 mg hydrocortisone shows excellent pharmacokinetics for emergency use with only a short delay in cortisol increase compared with i.m. injection. It has a good safety profile and is preferred by patients over i.m. injection. © 2013 European Society of Endocrinology.