Impact of dual-release hydrocortisone on disease control and metabolism in congenital adrenal hyperplasia: a retrospective cohort study.

Dual-release hydrocortisone was associated with a tendency toward worse hormonal control in CAH patients despite an overall increase in daily hydrocortisone equivalent dose.

• Study included 17 patients (10 males and 7 females) with classic CAH due to 21-OH-hydroxylase deficiency switched to DR-HC.
• Data were assessed at baseline, at six months, and at the last available visit.
• A trend of increase in androstenedione and 17-OHP levels was observed after switching to DR-HC.
• The proportion of patients with good disease control decreased from 5/17 (29%) at baseline to 1/17 (6%) at last available visit (p = 0.07).

Androstenedione to total testosterone ratio significantly deteriorated in male patients on DR-HC.

• The androstenedione to total testosterone ratio in males increased from 1.37 at baseline to 2.10 at follow-up (p = 0.04).
• This finding indicates a significant deterioration in androgen control specifically among male patients.
• The change was statistically significant at p = 0.04.

Total and LDL cholesterol levels significantly improved following the switch to DR-HC compared to prior conventional glucocorticoid regimens.

• Total cholesterol decreased from 178 mg/dL to 156 mg/dL (p = 0.015).
• LDL cholesterol decreased from 101 mg/dL to 83 mg/dL (p = 0.027).
• There were no significant changes in glucose profile.
• These metabolic improvements are consistent with previously reported benefits of DR-HC in adrenal insufficiency.

No adrenal crises were recorded during follow-up, indicating DR-HC is safe in terms of adrenal crisis prevention.

• Zero adrenal crises were recorded during the entire follow-up period across all 17 patients.
• Unsatisfactory disease control was the primary reason for discontinuation in 11/17 patients.
• The median duration of DR-HC treatment before discontinuation was 26 months.

Dual-release hydrocortisone may be unsuitable for CAH patients requiring tight regulation of androgen excess.

• 11 out of 17 patients discontinued DR-HC primarily due to unsatisfactory disease control.
• The once-daily modified-release formulation, while mimicking the circadian rhythm of cortisol, appears to provide insufficient suppression of adrenal androgen production in CAH.
• Data on DR-HC use specifically in CAH patients are described as 'scant' prior to this study.
• The study was retrospective with a cohort of only 17 patients, which is noted as a limitation.

The study population consisted of adults with classic CAH due to 21-hydroxylase deficiency who had previously been managed on conventional glucocorticoid regimens.

• 17 patients total: 10 males and 7 females.
• All patients had classic CAH due to 21-OH-hydroxylase deficiency.
• Patients were switched from conventional glucocorticoid treatment to DR-HC.
• This was a retrospective cohort study design.