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Absorption and tolerability of taste‐masked hydrocortisone granules in neonates, infants and children under 6 years of age with adrenal insufficiency
Author(s) -
Neumann Uta,
Whitaker Martin J.,
Wiegand Susanna,
Krude Heiko,
Porter John,
Davies Madhu,
Digweed Dena,
Voet Bernard,
Ross Richard J.,
Blankenstein Oliver
Publication year - 2018
Publication title -
clinical endocrinology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.055
H-Index - 147
eISSN - 1365-2265
pISSN - 0300-0664
DOI - 10.1111/cen.13447
Subject(s) - medicine , tolerability , cohort , hydrocortisone , adverse effect , primary adrenal insufficiency , palatability , adrenal insufficiency , pediatrics , anesthesia , physiology , pathology
Summary Objectives There is no licensed, dose‐appropriate formulation of hydrocortisone for children with adrenal insufficiency ( AI ) and patients rely on compounded adult medication. The aim of this study was to evaluate the absorption, palatability and safety of Infacort ® , an immediate‐release, granule formulation of hydrocortisone with taste masking. Study design Single site with satellites attended by a “flying” doctor from investigator site. Open‐label, single‐dose study in three consecutive child cohorts (n = 24) with AI ; Cohort 1, children aged 2 to <6 years (n = 12); Cohort 2, infants aged 28 days to <2 years (n = 6); Cohort 3, neonates aged 1 to <28 days (n = 6). Methods Fasted children were given a single dose of Infacort ® as dry granules administered directly from a capsule or spoon followed by a drink. The primary end‐point was the maximum serum cortisol concentration up to 240 minutes after Infacort ® administration. Secondary end‐points were palatability and adverse events ( AE s). Results All children showed an increase in cortisol above baseline after Infacort ® ( P < .0001), with geometric mean ± SD cortisol concentration at 60 minutes of 575.8 ± 299.5 nmol L −1 . There was no failure in administration of Infacort ® , and 95.5% of parents/carers preferred Infacort ® to their child's current medication. In 7 children who completed the palatability questionnaire, 80% of responses were very good or neutral, and 20% were adverse. No serious or severe treatment‐emergent AE s were reported. Conclusions Infacort ® is well tolerated, easy to administer to neonates, infants and children and shows good absorption, with cortisol levels at 60 minutes after administration similar to physiological cortisol levels in healthy children.