Endocrine Abstracts

Background: Twice-daily formulation of pasireotide, a pituitary-directed therapy, is approved for treatment of Cushing’s disease. Here we present data from a phase III study designed to evaluate the more convenient once-monthly long-acting release (LAR) formulation of pasireotide (approved for acromegaly) in patients with Cushing’s disease.Methods: Patients with persistent, recurrent, or de novo Cushing’s disease (not candidates for surger...

Introduction: The clinical outcome of patients with adrenal insufficiency (AI) has been shown to be less favorable than previously thought. Clinical studies have shown increased mortality, reduced cardiovascular and skeletal health and compromised quality of life, but the impact of this upon healthcare burden is unknown. This research utilised real-world evidence to compare comorbidities, healthcare utilization and expenditures in patients with AI.Method...

Background: In the 22-week LINC-2 study, osilodrostat (LCI699), a potent oral 11β-hydroxylase inhibitor, normalized urinary free cortisol (UFC) levels in 15 of 19 patients with Cushing’s disease (CD). The most common AEs were nausea, diarrhea, asthenia, and adrenal insufficiency (n=6 each). Here, we report the 31-month efficacy and safety results from LINC-2 extension.Methods: Patients receiving clinical benefit at week 22 could enter ...

Background: Pituitary apoplexy (PitApo) has significant associated-morbidity and its management is not yet standardised.Aim: To describe prevalence and characteristics of PitApo patients in GH deficient (GHD) patients compared with two control populations.Patients and methods: Patients with ‘infarction-apoplexy’ GHD aetiology code were identified from Pfizer International Metabolic Database (KIMS). Baseline characteristic...

Background: Pasireotide is a multireceptor-targeted somatostatin analogue that predominantly binds to somatostatin receptor subtype 5 (SSTR5) and provides sustained control of urinary free cortisol (UFC) levels in some patients with Cushing’s disease (CD). Cabergoline is a dopamine D2 receptor agonist with efficacy in some patients with CD. Most corticotropinomas co-express SSTR5 and D2, providing rationale for combination treatment with pasireotide and cabergoline. Resul...

Introduction: Long-acting pasireotide reduced urinary free cortisol (UFC) in most patients with Cushing’s disease (CD) during a large Phase III study (Lacroix et al. Lancet Diabetes Endocrinol 2018). The analyses presented here explored the impact of baseline characteristics on response to long-acting pasireotide.Methods: 150 patients with persistent, recurrent or de novo CD and mean UFC (mUFC; from three 24-hour samples collected ...

Introduction: During the 22-week LINC-2 study, the potent oral 11β-hydroxylase inhibitor osilodrostat normalized UFC in 15/19 (78.9%) patients with Cushing’s disease. Most common AEs were nausea, diarrhoea, asthenia, and adrenal insufficiency. This report describes 19-month results following an extension.Methods: Patients who were receiving clinical benefit at week 22 could enter the extension. Efficacy/safety is reported for patients who enter...

Background: The phase 3, open-label SONICS study of levoketoconazole demonstrated sustained reduction in mean urinary free cortisol (mUFC) in adults with endogenous Cushing’s syndrome (CS). The extended evaluation phase (Ext) of SONICS reported here further assessed long-term safety, tolerability, and benefit/risk of this treatment.Methods: SONICS consisted of dose-titration (150 – 600 mg BID to attain maximally tolerated dose for mUFC normal...

Introduction: The 12-month results of a multicentre, double-blind, Phase III study showing the efficacy and safety of a monthly, long-acting formulation of pasireotide in Cushing’s disease (CD) patients have been reported previously (Lacroix et al. Lancet Diabetes Endocrinol 2018). The results of the extension phase of this study are reported here.Methods: Patients (n=150) with persistent/recurrent or de novo CD and mean u...