SFEBES2022 Oral Communications Adrenal and Cardiovascular (6 abstracts)
1University Hospital Wales, Cardiff, United Kingdom; 2NIH, Bethesda, United state of America; 3University of Birmingham, Birmingham, United Kingdom; 4Hopital Louis Pradel, Bron, France; 5Karolinska, Stockholm, Sweden; 6Rigshospitalet, Copenhagen, United Kingdom; 7University of Sheffield, Sheffield, United Kingdom; 8Queen Elizabeth University Hospital, Glasgow, United Kingdom; 9Medizinische Klinik und Poliklinik IV, Klinikum der Universität München, Munich, Germany; 1010Radboud Univ Nijmegen Med Ctr, Nijmegen, Netherlands; 11GH Pitie Salpetriere, Paris, France; 12Diurnal, Cardiff, United Kingdom
Introduction: First-line treatment for congenital adrenal hyperplasia (CAH) is hydrocortisone1. When adequate control is not achieved, prednisolone (or its prodrug prednisone) are often used. However, there has been no formal comparison of disease control in CAH comparing prednis(ol)one vs hydrocortisone and patients are often on a glucocorticoid dose that exceeds the guideline recommended dose of hydrocortisone (≤25 mg/day)1,2. We report an interim analysis of CAH control in patients switched from prednis(ol)one to Modified-Release Hydrocortisone (MRHC) capsules, (Efmody, Diurnal Ltd, Cardiff UK), in an open label safety extension study.
Methods: Patients who completed the phase 3 MRHC study3, were invited to join an open label extension study. We analysed results from patients with a complete dataset at Phase 3 baseline on prednis(ol)one and a minimum of 18 months follow up in the extension study (n=30). Control of CAH was defined as 9am 17-OHP <36 nmol/l and dose was reported according to whether it exceeded 25 mg/day hydrocortisone dose equivalent (prednis(ol)one dose x 5)1,3. Quadrant analysis was performed and Fishers exact test applied.
Results: More patients had controlled 17-OHP on a physiological glucocorticoid dose on MRHC than prednis(ol)one, 57% vs 27% P=0.04.
Dose | |||
Prednis(ol)one | ≤25 mg/day | >25 mg/day | |
Androgen control | >36nmol/l 17-OHP | 8/30 (27%) | 5/30 (16%) |
<36nmol/l 17-OHP | 8/30 (27%) | 9/30 (30%) | |
Dose | |||
MRHC | ≤25 mg/day | >25 mg/day | |
Androgen control | >36nmol/l 17-OHP | 5/30 (16%) | 0/30 (0%) |
<36nmol/l 17-OHP | 17/30 (57%) | 8/30 (27%) |
Conclusions: Patients who are poorly controlled on prednis(ol)one and/or taking a dose above the recommended dose for adrenal replacement can benefit from a switch to MRHC capsules.
References: 1. Speiser PW. JCEM 2018 103(11):40434088. 2. Arlt W. JCEM 2010 95(11): 511051213. 3. Merke DP. JCEM 2021(106):e2063-e2077.