Switching Patients With Congenital Adrenal Hyperplasia to Modified‐Release Hydrocortisone Capsules: Relative Bioavailability and Disease Control
Primary result · Cortisol AUC0-inf after 20 mgResult — go to the resultRatio 108% 90% CI 103%–113%Authors' conclusion
MRHC showed comparable bioavailability to IRHC based on cortisol AUC after 20 mg administration. Switching patients treated with IRHC to a twice daily MRHC regimen on the same daily dose (giving approximately two thirds of the dose at night) is an effective protocol for starting MRHC treatment.
Study context
- Population
- Healthy male participants (bioavailability study); Congenital adrenal hyperplasia (CAH) patients managed with immediate-release hydrocortisone (IRHC) alone at baseline in phase 3 modified-release hydrocortisone capsules (MRHC) studyhealthy males, crossover
- Participants
- 24 participants
- Comparison
- MRHC vs IRHC
- Primary endpoint
- Relative bioavailability of MRHC vs IRHC (cortisol AUC0-inf)
Primary result
Cortisol AUC0-inf after 20 mg
Ratio
108%
90% CI 103%–113%
By group
As reported in the abstract
Further findings
| Outcome | P value |
|---|---|
| Phase 3: reduction in 09:00 h 17-hydroxyprogesterone in CAH patients switched from IRHC (122 recruited; 63 on IRHC alone) · 4 weeksGreater reduction with MRHC · post hoc analysis | P < 0.001 |
| Phase 3: reduction in 09:00 h androstenedione · 4 weeksGreater reduction with MRHC · post hoc analysis | P = 0.01 |
- Phase 3: reduction in 09:00 h 17-hydroxyprogesterone in CAH patients switched from IRHC (122 recruited; 63 on IRHC alone): MRHC n=32, IRHC n=31
Original publication
Switching Patients With Congenital Adrenal Hyperplasia to Modified‐Release Hydrocortisone Capsules: Relative Bioavailability and Disease Control. Clin Endocrinol (Oxf). Published 16 May 2025. doi:10.
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