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A Phase 2 Study of Chronocort, a Modified-Release Formulation of Hydrocortisone, in the Treatment of Adults With Classic Congenital Adrenal Hyperplasia
Open accessAbstract
CONTEXT: Treatment of congenital adrenal hyperplasia (CAH) is suboptimal. Inadequate suppression of androgens and glucocorticoid excess are common and current glucocorticoid formulations cannot replace the cortisol circadian rhythm. OBJECTIVES: The primary objective was to characterize the pharmacokinetic profile of Chronocort, a modified-release hydrocortisone formulation, in adults with CAH. Secondary objectives included examining disease control following 6 months of Chronocort with dose titration. DESIGN, SETTING, AND PATIENTS: Sixteen adults (eight females) with classic CAH participated in an open-label, nonrandomized, Phase 2 study at the National Institutes of Health Clinical Center. Twenty-four-hour blood sampling was performed on conventional glucocorticoids and following 6 months of Chronocort. Chronocort was initiated at 10 mg (0700 h) and 20 mg (2300 h). Dose titration was performed based on androstenedione and 17-hydroxyprogresterone (17-OHP) levels and clinical symptomatology. MAIN OUTCOME MEASURES: The primary outcome was cortisol pharmacokinetics of Chronocort and secondary outcomes included biomarkers of CAH control (androstenedione and 17-OHP). RESULTS: In patients with CAH, Chronocort cortisol profiles were similar to physiologic cortisol secretion. Compared with conventional therapy, 6 months of Chronocort resulted in a decrease in hydrocortisone dose equivalent (28 ± 11.8 vs 25.9 ± 7.1 mg/d), with lower 24-hour (P = .004), morning (0700-1500 h; P = .002), and afternoon (1500-2300 h; P = .011) androstenedione area under the curve (AUC) and lower 24-hour (P = .023) and morning (0700-1500 h; P = .02) 17-OHP AUC. CONCLUSIONS: Twice-daily Chronocort approximates physiologic cortisol secretion, and was well tolerated and effective in controlling androgen excess in adults with CAH. This novel hydrocortisone formulation represents a new treatment approach for patients with CAH.
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“Both the once-daily (56) and twice-daily (57) modified-released versions have been shown to be a closer mimic of the physiological circadian rhythm, compared to the conventional multiple-dose regimen.”
From Hypoglycaemia in adrenal insufficiency (2023) · cites this paper as [57]
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In the citing paper
“Infants prenatally exposed to betamethasone have altered responses of the HPA axis and a higher incidence of mental and behavioral disorders (490,491).”
From Congenital Adrenal Hyperplasia—Current Insights in Pathophysiology, Diagnostics, and Management (2022) · cites this paper as [490]
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“Continuous subcutaneous hydrocortisone infusion via an insulin pump mimicking cortisol circadian rhythm, has similarly shown adequate ACTH suppression with lower total hydrocortisone dose compared to conventional treatment, 139-142”
From Congenital adrenal hyperplasia (2017) · cites this paper as [140]
In the citing paper
“A modified-release oral hydrocortisone preparation, Chronocort ® , was successful in achieving lower androgen levels while decreasing the hydrocortisone equivalent dose using a twice-daily regimen in a Phase 2 study of 16 patients with classic 21OH deficiency.140”
From Congenital adrenal hyperplasia (2017) · cites this paper as [140]
In the citing paper
“Chronocort capsules demonstrated control of adrenal androgens throughout the day despite down-titration, with no serious adverse events109.”
From Management challenges and therapeutic advances in congenital adrenal hyperplasia (2022) · cites this paper as [109]
In the citing paper
“Compared with various forms of conventional therapy prior to entry, this approach yielded decreased 17OHP and androstenedione values throughout the day, despite a reduced HC dose equivalent (28 6 11.8 vs 25.9 6 7.1 mg/d).”
From Congenital Adrenal Hyperplasia Due to Steroid 21-Hydroxylase Deficiency: An Endocrine Society* Clinical Practice Guideline (2018) · cites this paper as [312]
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Metadata
- Authors
- Mallappa, A., Sinaii, N., Kumar, P., Whitaker, M. J., Daley, L.-A., Digweed, D., Eckland, D. J. A., Van Ryzin, C., Nieman, L. K., Arlt, W., Ross, R. J., & Merke, D. P.
- Affiliations
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (US)
- National Institutes of Health (US)
- Diurnal (United Kingdom) (GB)
- Corresponding author
- Mallappa, Ashwini
- Ross, Richard J.
- ORCID
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2015-03
- Volume
- 100
- Issue
- 3
- Pages
- 1137-1145
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- PMC
- PMC5393506
- OpenAlex
- W1976145935
- Cited by
- 167
- References
- 36
- Citations by year
- 2026: 11 · 2025: 16 · 2024: 17 · 2023: 11 · 2022: 16 · 2021: 10 · 2020: 11 · 2019: 16 · 2018: 18 · 2017: 17 · 2016: 19 · 2015: 5
- FWCI
- 5.61
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion, other-oa)
- Spiral (Imperial College London) (submittedVersion)
- Funders
- National Institutes of Health
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Sexual Differentiation and Disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal Regulation and Hypertension
- Keywords
- congenital adrenal hyperplasia, cortisol, modified-release formulation, diurnal cortisol rhythm, androstenedione, 17-hydroxyprogesterone, hyperandrogenism, treatment tolerability
- MeSH terms
- Adolescent, Adrenal Hyperplasia, Congenital, Adult, Capsules, Circadian Rhythm, Delayed-Action Preparations, Drug Administration Schedule, Female, Humans, Hydrocortisone, Male, Middle Aged, Quality of Life, Young Adult
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