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ea0070aep833 | Reproductive and Developmental Endocrinology | ECE2020

First in man study of oral native testosterone in hypogonadal men shows physiological testosterone levels in fed and fasted state

Newell-Price John , Porter John , Quirke Jo , Daniel Eleni , Mumdzic Enis , Ross Richard

Introduction: Current testosterone replacement therapies have limited acceptability: gels can be messy and risk inadvertent dosing of others; injections are painful; and oral testosterone undecanoate (TU) delivers variable testosterone levels, requires concurrent ingestion of a fatty meal and may produce supraphysiological dihydrotestosterone (DHT) levels1. We present the first human trial of an oral native testosterone preparation formulated to deliver testosterone...

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ea0099rc3.1 | Rapid Communications 3: Adrenal and Cardiovascular Endocrinology | Part I | ECE2024

Biochemical control with dose reduction in chronic glucocorticoid therapy over 4 years: A phase III extension study of Chronocort (Efmody) in the treatment of Congenital Adrenal Hyperplasia (CAH)

John M. Ross Richard , Merke Deborah P. , Arlt Wiebke , De La Perriere Aude Brac , Hirschberg Angelica , Newell-Price John D.C. , Prete Alessandro , Rees Aled , Reisch Nicole , Quinkler Marcus , Touraine Philippe A. , Maltby Kerry , Quirke Jo , Aslam Naila , Coope Helen , Porter John

Background: Management of CAH involves replacing cortisol deficiency and reducing raised adrenal androgens, however the supraphysiological glucocorticoid doses often required to treat hyperandrogenism are associated with poor long-term health outcomes. Modified-release hydrocortisone (MRHC) capsules, Efmody, replicate cortisol diurnal rhythm and improve control of CAH compared to standard glucocorticoid therapy. Here we report changes in glucocorticoid daily dose and 9am 17-hy...

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ea0099rc3.4 | Rapid Communications 3: Adrenal and Cardiovascular Endocrinology | Part I | ECE2024

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

Prete Alessandro , Theiler-Schwetz Verena , Arlt Wiebke , Chifu Irina-Oana , Harbeck Birgit , Napier Catherine , Newell-Price John D.C. , Rees Aled , Reisch Nicole , Stalla Gunter K. , Aslam Naila , Coope Helen , Maltby Kerry , Porter John , Quirke Jo , John M. Ross Richard

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) wh...

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ea0099p13 | Adrenal and Cardiovascular Endocrinology | ECE2024

Morning cortisol levels in patients with established primary adrenal insufficiency

Prete Alessandro , Theiler-Schwetz Verena , Arlt Wiebke , Chifu Irina-Oana , Harbeck Birgit , Napier Catherine , Newell-Price John D.C. , Rees Aled , Reisch Nicole , Stalla Gunter K. , Aslam Naila , Coope Helen , Maltby Kerry , Porter John , Quirke Jo , Ross Richard John M.

Background: Primary adrenal insufficiency (PAI) is rare: prevalence ~100140/million and incidence 4:1 000 000/year in Western societies 1. The diagnosis of PAI is suggested by an early-morning cortisol <140 nmol/l (5 μg/dl) 1. The commonest cause in adults is autoimmunity (~90% in Western countries) and it is generally considered progressive once the diagnosis is made, although it has been reported that residual cortis...

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ea0099p215 | Adrenal and Cardiovascular Endocrinology | ECE2024

Incidence of adrenal crisis in Congenital Adrenal Hyperplasia (CAH) patients during a prospective monitored long-term study of modified-release hydrocortisone (MRHC) capsules, (Efmody)

John M. Ross Richard , Merke Deborah P , Mallappa Ashwini , Arlt Wiebke , DeLaPerriere AudeBrac , Hirschberg Angelica , Newell-Price John DC , Prete Alessandro , Rees Aled , Reisch Nicole , Quinkler Marcus , Touraine Philippe A , Maltby Kerry , Quirke Jo , Aslam Naila , Coope Helen , Porter John

Background: Adrenal crisis is the leading cause of excess mortality in patients with CAH1. Retrospective studies report an adrenal crisis incidence of 5-10/100 patient years (PY), with mortality 0.5/100 PY2. Modified-release hydrocortisone (MRHC) capsules, (Efmody), replicate cortisol diurnal rhythm and improve androgen control in CAH compared to standard glucocorticoid therapy2. Here, we report the incidence of adrenal crisis in CAH patients f...