Stefanie Hahner1, Stephanie Burger-Stritt, Bruno Allolio. 1. Endocrinology and Diabetes Unit, Department of Medicine I, University Hospital Wuerzburg, Oberdürrbacher Strasse 6, D-97080 Wuerzburg, Germany. hahner_s@medizin.uni-wuerzburg.de
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 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.
RCT Entities:
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.
Authors: Hanna Nowotny; S Faisal Ahmed; Sophie Bensing; Johan G Beun; Manuela Brösamle; Irina Chifu; Hedi Claahsen van der Grinten; Maria Clemente; Henrik Falhammar; Stefanie Hahner; Eystein Husebye; Jette Kristensen; Paola Loli; Svetlana Lajic; Nicole Reisch Journal: Endocrine Date: 2021-03-04 Impact factor: 3.633
Authors: Leo Turner; Lam P Ly; Reena Desai; Gurmeet K S Singh; Timothy D Handelsman; Sasha Savkovic; Carolyn Fennell; Veena Jayadev; Ann Conway; David J Handelsman Journal: J Endocr Soc Date: 2019-06-28
Authors: Stefan R Bornstein; Bruno Allolio; Wiebke Arlt; Andreas Barthel; Andrew Don-Wauchope; Gary D Hammer; Eystein S Husebye; Deborah P Merke; M Hassan Murad; Constantine A Stratakis; David J Torpy Journal: J Clin Endocrinol Metab Date: 2016-01-13 Impact factor: 5.958