Long-term outcomes in patients with congenital adrenal hyperplasia treated with hydrocortisone modified-release hard capsules
Authors' conclusion
Modified-release hard capsule treatment resulted in hydrocortisone dose reduction followed by a stable dose with improved biochemical control associated with fertility. Biochemical control could be reliably monitored by a single blood sample taken between 09:00 and 13:00 h. The incidence of adrenal crises was below that reported previously in patients with CAH.
Study context
- Population
- Patients with classic CAH, mean age 37 years, 68% female22 discontinued
- Participants
- 91 patients
- Outcome
- Long-term efficacy: hydrocortisone dose and biochemical control
- Follow-up
- Median treatment 4 years (range 0.2-5.8)
Methodological detailssingle-arm
- Single-arm
Main finding
As reported in the abstract
- Median hydrocortisone dose at entry
- 30 mg/day
- Median hydrocortisone dose after 24 weeks, stable to 48 months
- 20 mg/day (P < .0001)
- Improved 17OHP
- P < .03
- Improved A4
- P < .002
- 17OHP < 4-fold upper limit of normal (ULN) after 4 years
- 71%
- A4 <ULN after 4 years
- 90%
Further findings
17OHP and A4 sampling time
- Measurement at 09:00 h and 13:00 h gave similar results
Fertility
- Pregnancies in women <50 years not on contraceptives (n=37)
- 5 (13.5%)
- Men with partner pregnancy
- 13.8% (4/29)
Safety
- Patients with adrenal crisis
- 7
- One patient reported
- 8 crises
- Incidence
- 3.9 crises per 100 patient years
Original publication
Long-term outcomes in patients with congenital adrenal hyperplasia treated with hydrocortisone modified-release hard capsules. Eur J Endocrinol. Published 17 June 2025. doi:10.
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