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Subcutaneous hydrocortisone administration for emergency use in adrenal insufficiency
Stefanie Hahner1, Stephanie Burger-Stritt, Bruno Allolio
1Endocrinology and Diabetes Unit, Department of Medicine I, University Hospital Wuerzburg, Oberdürrbacher Strasse 6, D-97080 Wuerzburg, Germany. hahner_s@medizin.uni-wuerzburg.de
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 cortisol >36 μg/dl (tserum cortisol >36 μg/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: 110±29 vs 97±28 μg/dl, P=0.27, tmax: 66±51 vs 91±34 min, P=0.17, and tserum 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.
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.
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