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ey0017.8-8 | Clinical Trials - New Treatments | ESPEYB17

8.8. Efficacy and safety of levoketoconazole in the treatment of endogenous Cushing’s syndrome (SONICS): A phase 3, multicentre, open-label, single-arm trial

M Fleseriu , R Pivonello , A Elenkova , R Salvatori , RJ Auchus , RA Feelders , EB Geer , Y Greenman , P Witek , F Cohen , BMK Biller

To read the full abstract: Lancet Diabetes Endocrinol. 2019; 7(11): 855-865. PMID: 31542384A.Endogenous Cushings syndrome is a rare, serious endocrine condition characterized by chronic overproduction of cortisol (1). It is most often caused by a pituitary adenoma (i.e. Cushings disease), while other causes include ectopic ACTH secretion or primary adrenal neopl...

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ey0016.8-6 | Important for Clinical Practice | ESPEYB16

8.6. Circadian rhythm of glucocorticoid administration entrains clock genes in immune cells: A DREAM trial ancillary study

MA Venneri , V Hasenmajer , D Fiore , E Sbardella , R Pofi , C Graziadio , D Gianfrilli , C Pivonello , M Negri , F Naro , AB Grossman , A Lenzi , R Pivonello , AM Isidori

To read the full abstract: J Clin Endocrinol Metab. 2018; 103(8): 29983009.Conventional glucocorticoid (GC) therapy in adrenal insufficiency (AI) does not fully mimic the endogenous cortisol circadian rhythm, and this may adversely affect long-term health. In the recent DREAM trial (Dual Release Hydrocortisone vs. Conventional Glucocorticoid Replacement in H...

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ey0018.8-9 | Clinical Trials – New Treatments | ESPEYB18

8.9. Efficacy and safety of osilodrostat in patients with Cushing's disease (LINC 3): a multicentre phase III study with a double-blind, randomised withdrawal phase

R Pivonello , M Fleseriu , J Newell-Price , X Bertagna , J Findling , A Shimatsu , F Gu , R Auchus , R Leelawattana , EJ Lee , JH Kim , A Lacroix , A Laplanche , P O'Connell , L Tauchmanova , AM Pedroncelli , BMK Biller

Lancet Diabetes Endocrinol. 2020; 8(9): 748761.https://pubmed.ncbi.nlm.nih.gov/32730798/The authors report the outcomes from the pivotal phase 3 trial in patients with Cushings disease of osilodrostat (a potent oral inhibitor of cytochrome P450 11B1, [mitochondrial 11β-hydroxylase]). Twice-daily osilodrostat rapidly reduced mean 24-h urine free cortisol (UFC) and sustained ...

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ey0015.8-11 | Clinical Trials – New Treatments | ESPEYB15

8.11 Effect of once-daily, modified-release hydrocortisone versus standard glucocorticoid therapy on metabolism and innate immunity in patients with adrenal insufficiency (DREAM): a single-blind, randomised controlled trial

AM Isidori , MA Venneri , C Graziadio , C Simeoli , D Fiore , V Hasenmajer , E Sbardella , D Gianfrilli , C Pozza , P Pasqualetti , S Morrone , A Santoni , F Naro , A Colao , R Pivonello , A. Lenzi

To read the full abstract: Lancet Diabetes Endocrinol. 2018; 6(3): 173-185Adrenal insufficiency (AI), caused by adrenal failure (primary) or hypothalamo-pituitary failure (secondary), has a prevalence of 250–450 per 1 million (16). AI is potentially life-threatening and requires lifelong glucocorticoid replacement therapy. Modified-release hydrocortisone preparations have bee...

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ESPE Yearbook of Paediatric Endocrinology

8.8. Efficacy and safety of levoketoconazole in the treatment of endogenous Cushing’s syndrome (SONICS): A phase 3, multicentre, open-label, single-arm trial

8.6. Circadian rhythm of glucocorticoid administration entrains clock genes in immune cells: A DREAM trial ancillary study

8.9. Efficacy and safety of osilodrostat in patients with Cushing's disease (LINC 3): a multicentre phase III study with a double-blind, randomised withdrawal phase

8.11 Effect of once-daily, modified-release hydrocortisone versus standard glucocorticoid therapy on metabolism and innate immunity in patients with adrenal insufficiency (DREAM): a single-blind, randomised controlled trial

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