Endocrine Abstracts

Background: Somapacitan is a reversible albumin-binding growth hormone (GH) derivative developed for once-weekly administration. Non-covalent binding to endogenous albumin delays somapacitan elimination, prolonging its half-life and duration of action. Somapacitan is not cleared by a specific organ, but impaired hepatic function may affect its pharmacokinetics. We report data from an open-label, parallel group, phase I trial (NCT03212131) investigating the pharmacokinetic and ...

Background: Somapacitan is a reversible albumin-binding growth hormone (GH) derivative developed for once-weekly administration that acts directly or indirectly via insulin-like growth factor I (IGF-I). As renal impairment may affect drug metabolism and excretion, we report data from an open-label, parallel group, phase I trial (NCT03186495) investigating the pharmacokinetic and pharmacodynamic properties, and safety of somapacitan in individuals with varying degrees of impair...

Background: Secondary adrenal insufficiency is usually treated with hydrocortisone replacement therapy twice or thrice daily in varying doses to mimic the physiological rhythm of cortisol release. However, despite efforts to optimize treatment regimens patients report impaired quality of life (QoL), including important aspects such as fatigue. A possible explanation is a suboptimal imitation of cortisol release resulting in an inadequate substitution at certain times during th...

Background: Patients with adrenal insufficiency (AI) exhibit increased morbidity, mortality and impaired quality of life (QoL) and conventional hydrocortisone replacement does not mimic the endogenous circadian pattern and may compromise adherence. A modified – release hydrocortisone formulation (Plenadren) for once-daily use is licensed in order to meet these needs.Objective: To audit the effects of treatment change from HC to Plenadren in an out-p...

Introduction: Subarachnoid haemorrhage (SAH) is associated with a mortality rate of 30% and the survivors face significant morbidity including fatigue, isolation, depression and sleep disorders; factors affecting general health related quality of life (QoL). QoL is also known to be decreased in pituitary-hypothalamic insufficiency and tends to improve after treatment. SAH has been suggested to be a common cause of hypopituitarism by some whereas not by others. We aimed to inve...

Introduction: Acromegaly is a rare disease caused by GH hypersecretion from a pituitary adenoma. However, accurate estimates of incidence and prevalence are scarce and not based on nationwide populations. It is well known that surgical cure may normalize mortality and improve morbidity but similar data are not available for patients receiving medical treatment.Method: We first validated the ICD-8 and ICD-10 diagnosis codes for acromegaly in The National ...

Somapacitan is a long-acting, reversible albumin-binding growth hormone (GH) derivative. The objective of this trial was to evaluate the safety, efficacy and treatment satisfaction of onceweekly somapacitan versus daily GH (Norditropin) over 52 weeks in Japanese patients with adult GH deficiency (AGHD). This was a phase 3, multicentre, randomised, open-label, parallel-group, active-controlled trial (NCT03075644). Patients previously treated with GH were randomised 1:3 to daily...

Background: Replicating the physiological cortisol secretion is key in treatment of glucocorticoid insufficient individuals. A sub-optimal replication may explain the impaired quality of life experienced by these individuals. The study investigates fatigue measured by ecological momentary assessments in patients treated with conventional hydrocortisone compared with a once-daily dual-release formula of hydrocortisone (Plenadren) that follows the cortisol physiology more closel...

In patients with adult growth hormone deficiency (AGHD), the dose of growth hormone (GH) replacement is individualised based on clinical outcome, insulin-like growth factor-I (IGF-I) levels and adverse reactions. The aim of this analysis was to characterise dose–IGFI–response for somapacitan, a long-acting reversible albumin-binding GH derivative, and to derive expected IGF-I levels for various starting doses. Somapacitan dose–IGF-I–response analysis wa...

Somapacitan is a long-acting growth hormone (GH) derivative designed for once-weekly subcutaneous administration. Correct assessment of insulin-like growth factor-I (IGF-I) levels is essential during treatment of GH deficiency (GHD) and must account for fluctuations over a dosing interval. We evaluated whether reliable estimates of weekly mean and peak IGF-I could be obtained from a single IGF-I sample. A population pharmacokinetic/pharmacodynamic model was available from phar...