ECE2023 Poster Presentations Adrenal and Cardiovascular Endocrinology (72 abstracts)
Glucocorticoid-induced adrenal insufficiency: Identification of diagnostic and prognostic biomarkers based on two randomized controlled trials - REFINE
Simon Bøggild Hansen 1,2 , Anja Fenger Dreyer 3,4 , Stina Willemoes Borresen 5 , Hajir Al-Jorani 3,4 , Lise Sofie Bislev 1 , Victor Brun Boesen 5 , Louise Lehmann Christensen 3 , Dorte Glintborg 3 , Richard Christian Jensen 3 , Nanna Thurmann Jørgensen 5,6 , Marianne Klose 5 , Marie Louise Lund 5 , Jelena Stankovic 1,2 , Randi Tei 1 , Torquil Watt 5,6 , Paul M Stewart 7 , Marianne Andersen 3,4 , Ulla Feldt-Rasmussen 5,6 & Jens Otto Jørgensen 1,2
1Aarhus University Hospital, Department of Endocrinology and Internal Medicine, Aarhus N, Denmark; 2Aarhus University, Department of Clinical Medicine, Aarhus N, Denmark; 3Odense University Hospital, Department of Endocrinology, Odense C, Denmark; 4University of Southern Denmark, Department of Clinical Research, Odense C, Denmark; 5Copenhagen University Hospital, Rigshospitalet, Department of Endocrinology and Metabolism, Copenhagen, Denmark; 6University of Copenhagen, Department of Clinical Medicine, Copenhagen, Denmark; 7University of Leeds, Faculty of Medicine & Health, Leeds, United Kingdom
Background: The risk and course of glucocorticoid-induced adrenal insufficiency (GIA) are unclear and current evidence is retrospective and based on small and selected study populations. However, the prevalence of glucocorticoid use is at least 3 %, which underscores the need for unbiased and prospective assessment of the prevalence and clinical consequences of GIA.
Objectives: To identify biomarkers of GIA as regards diagnosis, prognosis and responsiveness to hydrocortisone replacement.
Patients and Methods: The study (REFINE) is nested in two ongoing randomized controlled trials, RESCUE and REPLACE (Table 1). Both studies screen potential participants by an ACTH test with GIA defined as a stimulated 30 minute plasma cortisol concentration <420 nmol/l. We aim to prospectively screen 2.800 and enroll 555 patients in the two studies. Patients contribute blood samples at the baseline visits and after completion of the RCTs. Demographics, lifestyle factors, disease characteristics, co-morbidities, medication and patient reported outcomes (PROs) are recorded at baseline and at study end. We aim to generate diagnostic, prognostic and predictive GIA biomarkers with a stepwise analysis. First step involves univariate analyses to identify single biomarkers and generating an outline of variables for the proceeding analyses. Further analyses will proceed in two directions, prediction and explanatory associations. Selection of candidate variables for our prediction models will be based on findings in our univariate analyses and published literature and include among others a broad spectrum of clinical, biochemical, genetic as well as patient-, disease- and treatment-related variables. Our approach to establish multivariate predictions models will adhere to current guidelines.
| Study | Population | Other inclusion criteria | Grouping based on ACTH-test: ACTH-stimulated cortisol at inclusion | Intervention (RCT groups) | Study length |
| RESCUE n=325 | Patients with giant cell arteritis and/or polymyalgia rheumatica Age ≥50 years Prednisolone treatment ≥12 weeks | Ongoing prednisolone treatment ≥0 mg/day and ≤ 5 mg/day | RCT: <420 nmol/l (n=250) Control: ≥420 nmol/l (n=75) | Hydrocortisone vs placebo during stress | 6 months |
| REPLACE n=230 | Planned cessation of prednisolone treatment ≥2 weeks and ≤ 12 weeks ago | RCT: 100-419 nmol/l (n=150) Control 1: <100 nmol/l (n=20) Control 2: ≥420 nmol/l (n=60) | Hydrocortisone vs placebo | 12 months |
Perspectives: This study, together with the results of RESCUE and REPLACE, will support clinical decision-making as regards predicting, diagnosing and managing GIA.
Funding: Achieved from the Novo Nordisk Foundation as part of a collaborative grant entitled “DOUBLE EDGE – Characterization and mitigation of adverse effects of glucocorticoid treatment” (NNF20OC0063280).
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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