Evaluation of the pharmacokinetics and safety of s.c. hydrocortisone injection for use in adrenal emergency.
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 (C max), time to C max (t max), and time to serum cortisol >36 μg/dl (t serum cortisol >36 μg/dl) after s.c. administration compared with i.m. administration, safety, and patient preference.
Serum cortisol increased rapidly and substantially after both i.m. and s.c. injections (C max: 110±29 vs 97±28 μg/dl, P=0.27, t max: 66±51 vs 91±34 min, P=0.17, and t serum cortisol >36 μg/dl: 11±5 vs 22±11 min, P=0.004 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.
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.