Real-World Outcomes with Modified-Release Hydrocortisone in Classic Congenital Adrenal Hyperplasia
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ID: 314253
2026
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Abstract
OBJECTIVE: To evaluate outcomes after switching from conventional glucocorticoids to modified-release hydrocortisone (MR-HC; Efmody®) in adults with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency under real-life conditions. DESIGN: Prospective, observational cohort study at a tertiary endocrine center. METHODS: Sixty-two adults with classic CAH (25 male; 42 salt-wasting) were switched to MR-HC and followed up for at least 12 months and up to four visits or until termination of treatment (median 23.5 months; visit four not yet completed in 6/62). Outcomes included hormonal control, metabolic parameters and menstrual patterns. RESULTS: At baseline, 42/62 patients had androstenedione (A4) within the reference range, 13/62 showed elevated concentrations and 7/62 had suppressed concentrations. At the last available visit, 11/13 of patients with elevated A4 normalized. Salivary 17-hydroxyprogesterone decreased significantly in the early morning (p=0.025), 12 pm (p=0.036) and 4 pm (p=0.042). Median hydrocortisone-equivalent dose declined from 30 mg (IQR 25-37.5) to 25 mg (IQR 20-30) (p<0.001). HOMA-IR improved (2.15 to 1.67; p=0.023), while other metabolic parameters remained stable. Daytime blood systolic and diastolic pressure decreased by ∼5 mmHg (p=0.007 and p=0.003). Fludrocortisone was reduced in 12/41 (29.3%) salt-wasting patients. Among women with menstrual disturbances (12/42), 6/12 normalized and 1/12 conceived; among women with regular cycles, 3/12 developed irregular cycles or amenorrhea. The adrenal crisis rate was 5.0 per 100 patient-years. CONCLUSION: MR-HC enabled stable biochemical control with reduced glucocorticoid exposure and was associated with improvements in insulin sensitivity, blood pressure, and menstrual regularity, supporting its role as a safe and physiological treatment option in adults with CAH.
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| Authors | Matthias K. Auer, Kathrin Bayer, H. Nowotny, Lea Tschaidse, Orsela Dervishi, Ann-Christin Welp, Christian Lottspeich, Martin Bidlingmaier, Sonja Kunz, Nicole Reisch |
| Journal | european journal of endocrinology |
| Year | 2026 |
| DOI |
10.1093/ejendo/lvag087
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| URL | |
| Keywords | Keywords not found |
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