June 22, 2014
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Modified-release hydrocortisone improved androgen biomarkers in congenital adrenal hyperplasia

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CHICAGO — A modified-release hydrocortisone formulation could improve biochemical control for patients with congenital adrenal hyperplasia, according to research presented at the joint meeting of the International Congress of Endocrinology and the Endocrine Society.

Perspective from Antoine Tabarin, MD

“Chronocort (hydrocortisone, Diurnal, Ltd.) twice-daily, novel modified hydrocortisone capsule formation approximates physiological cortisol secretion and replaces the overnight rise in cortisol,” Ashwini Mallappa, MD, of the National Institutes of Health, Bethesda, Md., said during her presentation.

Ashwini Mallappa, MD

Ashwini Mallappa, MD

In a phase 2, open-label, non-randomized trial, Mallappa and colleagues enrolled 16 adults (50% female; aged 29±13 years) with classic congenital adrenal hyperplasia (CAH) to evaluate disease control after 6 months of Chronocort therapy compared to conventional therapy. Prior to Chronocort treatment, patients were on varied conventional glucocorticoid therapies Mallappa said. 

The researchers obtained hormone profiling at baseline (conventional glucocorticoid) and every 2 months. Patients were started on a standard Chronocort dose of, 20 mg at 23:00 and 10 mg at 07:00 hours. Dose titrations were made based on clinical status and optimal hormonal ranges Chronocort cortisol pharmacokinetic profile approximated physiological cortisol secretion, according to Mallappa. This phase 2 study demonstrated significant control of the disease biomarkers as measured by 24-hr levels of the androgens, 17-hydroxyprogesterone and androstenedione which were brought into their optimal ranges after 6-months treatment with titrated Chronocort as compared to the conventional therapy, Mallappa told Endocrine Today

“Further studies — including children — are necessary to determine the long-term effects of Chronocort therapy and planning is underway,” Mallappa said. — by Allegra Tiver

For More Information: Mallappa A. Abstract OR02-5. Presented at: The joint meeting of the International Congress of Endocrinology and the Endocrine Society; June 21-23, 2014; Chicago.

Disclosures: Mallappa reports no relevant disclosures.