medwireNews: The Infacort® hydrocortisone preparation of taste-masked granules can be used in children of all ages, including neonates, report researchers.
Infacort® (Diurnal Limited, Cardiff, UK) has undergone an as yet unpublished phase III trial in Europe, and the manufacturer submitted it for European marketing authorisation at the end of last year. It is at phase II development in the USA.
The preparation can be taken on its own or mixed with a little food, followed by a drink. In the current study, 95.5% of the patients’ carers preferred Infacort® to their child’s usual hydrocortisone preparation, and would be happy to use it in future. Most (82.6%) said their child found it easy to swallow the preparation and 65.2% felt their child had reacted to it positively.
The researchers note that the preparation had a neutral taste, rather than being sugar-sweetened as is common with compounded hydrocortisone preparations. All six of the patients who were old enough to complete a survey reported the taste as good or neutral, and all but one were willing to take it again in future.
Oliver Blankenstein (Charité Universitätsmedizin Berlin, Germany) and co-researchers first tested Infacort® in 12 children aged from 2 to less than 6 years, and in six infants aged between 28 days and 2 years, before attempting it in six neonates. All the study participants had congenital adrenal hyperplasia, except for one child with hypopituitarism.
Infacort® was provided in capsules containing 0.5, 1.0, 2.0 or 5.0 mg hydrocortisone, and the patients were given a single dose that was equivalent to their usual hydrocortisone dose, at least 2 hours after last food (45 minutes in those younger than 1 year).
Average serum cortisol levels 60 minutes after administration were 575.77 nmol/L in the study cohort overall and 547.13, 450.10 and 815.71 nmol/L in the children, infants and neonates, respectively. All patients achieved levels that were significantly above baseline, and this remained true in 82.6% of patients 240 minutes after administration.
“There was no comparator hydrocortisone preparation in this study as there is no licensed dose-appropriate preparation of hydrocortisone and there is neither a standard method for compounding hydrocortisone nor for administering compounded hydrocortisone”, writes the team in Clinical Endocrinology.
However, they note that their study participants all achieved serum cortisol levels that were in line with physiological levels in healthy children.
A third of the children had treatment-emergent adverse events, all mild or moderate and most commonly gastrointestinal. None were judged to be related to treatment.
“Further studies are now needed to determine the optimum replacement regime in childhood using a therapy such as Infacort® which is available in a dose-appropriate form designed for children”, conclude the researchers.
Clin Endocrinol 2017; Advance online publication
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