PMID- 28815660
OWN - NLM
STAT- MEDLINE
DCOM- 20180815
LR  - 20220408
IS  - 1365-2265 (Electronic)
IS  - 0300-0664 (Linking)
VI  - 88
IP  - 1
DP  - 2018 Jan
TI  - Absorption and tolerability of taste-masked hydrocortisone granules in neonates, 
      infants and children under 6 years of age with adrenal insufficiency.
PG  - 21-29
LID - 10.1111/cen.13447 [doi]
AB  - 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((R)) , 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((R)) 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((R)) 
      administration. Secondary end-points were palatability and adverse events (AEs). 
      RESULTS: All children showed an increase in cortisol above baseline after 
      Infacort((R)) (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((R)) , and 95.5% of parents/carers preferred Infacort((R)) 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 AEs were reported. CONCLUSIONS: 
      Infacort((R)) 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.
CI  - (c) 2017 The Authors. Clinical Endocrinology Published by John Wiley & Sons Ltd.
FAU - Neumann, Uta
AU  - Neumann U
AUID- ORCID: 0000-0003-3892-0577
AD  - Charite Universitatsmedizin Berlin, Berlin, Germany.
FAU - Whitaker, Martin J
AU  - Whitaker MJ
AD  - Diurnal Limited, Cardiff, UK.
FAU - Wiegand, Susanna
AU  - Wiegand S
AD  - Charite Universitatsmedizin Berlin, Berlin, Germany.
FAU - Krude, Heiko
AU  - Krude H
AD  - Charite Universitatsmedizin Berlin, Berlin, Germany.
FAU - Porter, John
AU  - Porter J
AD  - Diurnal Limited, Cardiff, UK.
FAU - Davies, Madhu
AU  - Davies M
AD  - Diurnal Limited, Cardiff, UK.
FAU - Digweed, Dena
AU  - Digweed D
AD  - Diurnal Limited, Cardiff, UK.
FAU - Voet, Bernard
AU  - Voet B
AD  - Diurnal Limited, Cardiff, UK.
FAU - Ross, Richard J
AU  - Ross RJ
AD  - The University of Sheffield, Sheffield, UK.
FAU - Blankenstein, Oliver
AU  - Blankenstein O
AD  - Charite Universitatsmedizin Berlin, Berlin, Germany.
LA  - eng
PT  - Journal Article
DEP - 20170907
PL  - England
TA  - Clin Endocrinol (Oxf)
JT  - Clinical endocrinology
JID - 0346653
RN  - WI4X0X7BPJ (Hydrocortisone)
SB  - IM
MH  - Adrenal Insufficiency/*drug therapy
MH  - Age Factors
MH  - Child, Preschool
MH  - Humans
MH  - Hydrocortisone/*administration & dosage/blood/therapeutic use
MH  - Infant
MH  - Infant, Newborn
MH  - Parents/psychology
MH  - Surveys and Questionnaires
MH  - *Taste
OTO - NOTNLM
OT  - adrenal insufficiency
OT  - congenital adrenal hyperplasia
OT  - infants
OT  - neonates
OT  - oral hydrocortisone granules
EDAT- 2017/08/18 06:00
MHDA- 2018/08/16 06:00
CRDT- 2017/08/18 06:00
PHST- 2017/06/14 00:00 [received]
PHST- 2017/08/10 00:00 [revised]
PHST- 2017/08/10 00:00 [accepted]
PHST- 2017/08/18 06:00 [pubmed]
PHST- 2018/08/16 06:00 [medline]
PHST- 2017/08/18 06:00 [entrez]
AID - 10.1111/cen.13447 [doi]
PST - ppublish
SO  - Clin Endocrinol (Oxf). 2018 Jan;88(1):21-29. doi: 10.1111/cen.13447. Epub 2017 
      Sep 7.