Searchable abstracts of presentations at key conferences in endocrinology

ea0037ep54 | Adrenal cortex | ECE2015

A phase 1, randomised, open-label, four-period crossover, single-dose study to evaluate the pharmacokinetics of hydrocortisone modified release tablets

Johannsson Gudmundur , Lennernas Hans , Marelli Claudio , Rockich Kevin , Skrtic Stanko

Novel biopharmaceutical techniques have allowed the development of a hydrocortisone modified release (MR) tablet (once-daily administration for replacement therapy in adrenal insufficiency) mimicking more closely the physiological serum cortisol profile. Robust bioavailability is needed to secure this new treatment safety.Aims: To compare single-dose pharmacokinetics (PK) of MR tablets manufactured at two different sites by assessing intra-subject variab...

ea0032p24 | Adrenal cortex | ECE2013

Management of Addison's disease patients using dual release hydrocortisone during periods of intercurrent illness

Simonsson Ulrika SH , Skrtic Stanko , Lennernas Hans , Marelli Claudio , Johannsson Gudmundur

Introduction: Current management of intercurrent illness (ICI) in adrenal insufficiency (AI) is inadequate. We attempted to optimise ICI regimens with pharmacokinetic simulations of a dual-release (DR) hydrocortisone (HC) and tested them in a formal clinical trial.Methods: This work consisted of: i) dosing recommendations in episodes of mild ICI with DR-HC using simulations with a population pharmacokinetic model, ii) collection of ICI episodes with incr...

ea0014oc8.6 | Neuroendocrinology clinical | ECE2007

Improved glucocorticoid replacement therapy by a novel oral hydrocortisone modified-release tablet

Skrtic Stanko , Lennernäs Hans , Nilsson Anna , Bergthorsdottir Ragnhildur , Hedner Thomas , Johannsson Gudmundur

Background: Mortality rate in patients with primary and secondary adrenal insufficiency is increased. A contributing factor could be the dose and the pattern of glucocorticoid replacement therapy. Hydrocortisone administered twice or thrice daily produces high serum peaks and low trough values in-between. A novel, once daily, hydrocortisone modified release tablet with combined immediate and extended release characteristics was developed.Purpose: The aim...

ea0041gp14 | Adrenal (1) | ECE2016

A Phase 3b, open-label, extension study to evaluate the long-term safety of once-daily, dual-release hydrocortisone (DR-HC) in patients with adrenal insufficiency (AI)

Nilsson Anna , Bergthorsdottir Ragnhildur , Burman Pia , Dahlqvist Per , Ekman Bertil , Eden Engstrom Britt , Ragnarsson Oskar , Skrtic Stanko , Wahlberg Jeanette , Achenbach Heinrich , Uddin Sharif , Marelli Claudio , Johannsson Gudmundur

Introduction: Glucocorticoid replacement for adrenal insufficiency (AI) remains inadequate, resulting in high morbidity, premature mortality and quality-of-life (QoL) impairment. This study investigated the long-term safety of dual-release hydrocortisone (DR-HC) in patients with primary AI.Methods: AI patients who completed a randomized, 3-month crossover study of once-daily DR-HC versus thrice-daily conventional immediate-release hydrocortisone plus a 6...

ea0056gp30 | Adrenal clinical | ECE2018

The urinary cortisol metabolome in patients with adrenal insufficiency: dual-release hydrocortisone is less deleterious than conventional hydrocortisone therapy

Espiard Stephanie , McQueen Johanna , Sherlock Mark , Ragnarsson Oskar , Bergthorsdottir Ragnhildur , Burman Pia , Dahlqvist Per , Ekman Bertil , Engstrom Britt Eden , Nilsson Anna G , Skrtic Stanko , Wahlberg Jeanette , Stewart Paul M , Johannsson Gudmundur

Introduction: Oral once-daily dual-release hydrocortisone (DR-HC) therapy provides a more physiological cortisol profile than conventional thrice-daily (TID) replacement therapy and has demonstrated improved metabolic profile among patients with adrenal insufficiency (AI). The mechanisms by which this metabolic improvement occurs may be due to less total exposure, changed cortisol time exposure profile, but also modified metabolism of cortisol.Objective:...

ea0056p160 | Steroid metabolism + action | ECE2018

Urinary steroid profile in patients with primary adrenal insufficiency under conventional glucocorticoid replacement: a case control study

Espiard Stephanie , McQueen Johanna , Ragnarsson Oskar , Bergthorsdottir Ragnhildur , Burman Pia , Dahlqvist Per , Ekman Bertil , Eden Engstrom Britt , Nilsson Anna G. , Skrtic Stanko , Wahlberg Jeanette , Sherlock Mark , Stewart Paul M. , Johannsson Gudmundur

Introduction: Primary adrenal insufficiency (PAI) leads to a drastically reduced production of steroids from the adrenal cortex, but a few patients may keep some residual adrenal steroid secretion that may simplify replacement therapy and prevent adrenal crisis. Irrespectively, the conventional glucocorticoid (GC) replacement therapy, using thrice-daily oral hydrocortisone, does not restore the patients’ physiological cortisol profile.Objective: The...