ECE2024 Rapid Communications Rapid Communications 3: Adrenal and Cardiovascular Endocrinology | Part I (7 abstracts)
CHAMPAIN study: Initial results from a phase II study of efficacy, safety and tolerability of modified-release hydrocortisones: Chronocort® (Efmody®) versus Plenadren®, in primary adrenal insufficiency
Alessandro Prete 1,1 , Verena Theiler-Schwetz 1 , Wiebke Arlt 2 , Irina-Oana Chifu 3 , Birgit Harbeck 4,5 , Catherine Napier 6 , John D.C. Newell-Price 7 , Aled Rees 8 , Nicole Reisch 9 , Günter K. Stalla 10 , Naila Aslam 11 , Helen Coope 11 , Kerry Maltby 11 , John Porter 11 , Jo Quirke 11 & Richard John M. Ross 7
1University of Birmingham, United Kingdom; 2MRC Laboratory of Medical Sciences, United Kingdom; 3University Hospital Würzburg, Würzburg, Germany; 4amedes experts, Hamburg, Germany; 5University Medical Center Hamburg-Eppendorf, Hamburg, Germany; 6Newcastle University, United Kingdom; 7The University of Sheffield, United Kingdom; 8Cardiff University, United Kingdom; 9Endokrinologie, Nephrologie und weitere Sektionen, München, Germany, 10Ludwig Maximilian University of Munich, München, Germany, 11Diurnal, United Kingdom
Background: Current glucocorticoid replacement regimens for patients with primary adrenal insufficiency (PAI) mean patients wake with either low or undetectable cortisol levels1, associated with fatigue and a reduced quality of life (QoL)2. Plenadren® (Takeda, UK) is a once-daily modified-release formulation of hydrocortisone that replaces daytime cortisol levels whereas Chronocort® (modified-release hydrocortisone hard capsules, Diurnal, UK) when taken twice-daily, has been shown to replicate the normal overnight rise in serum cortisol concentration and provide physiological levels throughout the day. We have undertaken a double-blind, double-dummy, two-way cross-over, randomised, phase II study of efficacy, safety and tolerability of modified-release hydrocortisones: Chronocort® Versus Plenadren®.
Aim: To test the hypothesis that Chronocort® provides more physiological waking cortisol levels than Plenadren®.MethodologyThe study was conducted across 8 sites in the UK and Germany. Male and female patients, aged ≥18 with confirmed PAI (defined as morning pre-dose cortisol <50 nmol/l) on stable therapy over the preceding three months and not currently treated with Chronocort®/Plenadren®. Participants with congenital adrenal hyperplasia (CAH), secondary or tertiary AI were excluded. Each participant was randomised on a 1:1 basis to either; treatment sequence I (Chronocort® first) or treatment sequence II (Plenadren® first) taking a 25 mg total daily dose for 4 weeks; either Plenadren® 25 mg in the morning or Chronocort® 10 mg in the morning and 15 mg at night with the associated dummy preparation followed immediately by the other treatment. The pre-dose morning serum cortisol level was assayed at baseline and after each treatment period. A physiological morning cortisol level was defined as a pre-dose level of >140 nmol/l. Secondary measures included: morning fatigue measured using the Multidimensional Assessment of Fatigue (MAF) questionnaire and the PROMIS® 7b questionnaire; QoL was assessed using the EuroQol 5-level Standardised Health Questionnaire (EQ-5D-5L™); Health-related Quality of Life in Addison’s disease (AddiQoL) questionnaire and the 36-Item Short Form Health Survey (SF-36®) questionnaire.
Results: Of 49 evaluable participants with PAI, 45 achieved a physiological morning cortisol after four weeks of Chronocort® compared with 2 after four weeks of Plenadren® (P<0.0001). The mean (standard deviation) waking cortisol was 422.85 (203.50) vs 36.98 (113.87), respectively.Conclusion: Chronocort® provides more physiological waking cortisol levels than Plenadren®. Further analysis will test the hypothesis that waking with physiological cortisol levels improves fatigue and QoL in patients with PAI.
References: 1. Mah PM, et al. Clin Endocrinol (Oxf). 2004;61(3):367-75.
2. Wichers M, et al. Clin Endocrinol (Oxf). 1999;50(6):759-65.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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