ECEESPE2025 Oral Communications Oral Communications 13: Adrenal and Cardiovascular Endocrinology Part 2 (6 abstracts)
A double-blind study of modified-release hydrocortisones, chronocort versus plenadren, in adrenal insufficiency (CHAMPAIN)
Alessandro Prete 1 , Verena Theiler-Schwetz 1 , Wiebke Arlt 2 , Irina-Oana Chifu 3 , Birgit Harbeck 4 , Catherine Napier 5 , John Newell-Price 6 , Aled Rees 7 , Nicole Reisch 8 , Gunter Stalla 9 , Helen Coope 10 , John Porter 10 , Jo Quirke 10 & Richard Ross 6
1University of Birmingham, Birmingham, United Kingdom; 2MRC Laboratory of Medical Sciences, London, United Kingdom; 3University Hospital of Würzburg, Germany, Wurzburg, Germany; 4Amedes MVZ Hamburg, Hamburg, Germany; 5Newcastle University, Newcastle, United Kingdom; 6University of Sheffield, Sheffield, United Kingdom; 7Cardiff University, Cardiff, United Kingdom; 8Ludwig-Maximilians-Universität München, Munchen, Germany; 9Ludwig-Maximilians-Universität, Munchen, Germany; 10Neurocrine UK, Cardiff, United Kingdom
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Background: Patients with adrenal insufficiency (AI) have impaired quality of life (QoL), low energy and increased mortality. Immediate-release hydrocortisone is first-line replacement therapy, however, fails to restore the physiologic diurnal cortisol rhythm. There are two modified-release hydrocortisone formulations: 1) Plenadren®, taken in a single morning dose, and 2) Chronocort® delayed release, taken twice daily in a toothbrush regimen (last thing at night, first thing in the morning). Chronocort but not Plenadren mimics the physiologic rise in early morning cortisol. We compared Plenadren to Chronocort to test the hypothesis that waking with physiological cortisol levels will reduce fatigue and improve QoL.
Methods: double-blind, double-dummy, two-way cross-over, randomised, study comparing Chronocort vs Plenadren, one month on each treatment at 25mg/24 hours. Inclusion criteria were primary AI with morning pre-dose cortisol <50 nmol/l (1.8 µg/dl). The primary endpoint was the difference in 07:00 h cortisol after 4 weeks of treatment. The key secondary outcome was the Multidimensional Assessment of Fatigue (MAF) score after 4 weeks. Other secondary outcomes included the disease specific questionnaire AddiQol, the fatigue questionnaire PROMIS 7b, and QoL as measured by SF36 and EQ-5D-5L.
Results: Of 49 evaluable participants, 45 achieved a physiological morning cortisol (>140 nmol/l, 5ug/dl) with Chronocort compared with 2 on Plenadren (median serum cortisol 417.0 (15) vs 6.04 (0.2) nmol/l (µg/dl), P<0.0001). The MAF score was not significantly different between the two treatments; however, a sensitivity analysis showed that in the first treatment period Chronocort reduced MAF Score (P=0.008) suggesting a carry-over effect from period 1 to 2. The majority of the other QoL measures in the secondary efficacy analysis showed significant benefit for Chronocort including: The disease specific questionnaire AddiQol (P=0.03), the fatigue questionnaire PROMIS 7b (P=0.02), SF36 physical functioning (P=0.03) and EQ-5D-5L (P=0.02). The sensitivity analysis for all these measures showed greater benefit for Chronocort and patients showed a preference for the Chronocort treatment period. The safety profiles were similar, as expected for patients with AI, with no new safety signals identified.
Conclusions: In adrenal insufficiency Chronocort provides physiological waking cortisol levels and is associated with reduced fatigue and improved QoL as compared to Plenadren.
Volume 110
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Endocrine Abstracts
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