Endocrine Abstracts

Background: Previous studies have yielded conflicting results on biochemical control with medical therapy in patients with or without prior pituitary surgery. The LANTERN study (NCT02493517) demonstrated that lanreotide autogel (LAN ATG) was non-inferior to lanreotide prolonged release (LAN PR) in Chinese patients with active acromegaly. This post hoc analysis of the LANTERN study aimed to explore the efficacy of LAN ATG in patients with or without prior pituitary surgery....

Background: The LANTERN study (NCT02493517) has demonstrated that lanreotide autogel (LAN ATG) was non-inferior to lanreotide prolonged release (LAN PR) in Chinese patients with active acromegaly. This post hoc analysis of the LANTERN study assessed the impact of tumor size on treatment effect.Design: In the LANTERN study, LAN ATG was started at 90 mg and subsequently titrated according to GH and IGF-1 levels for 32 weeks. Tumor diameters > 10 mm wer...

Introduction: Around 20–30% of patients with acromegaly have hyperprolactinemia, which is associated with infertility and gonadal/sexual dysfunction. Current therapy involves somatostatin analogues for GH/IGF1 excess and a dopamine agonist to decrease prolactin levels. The objectives of this analysis were to assess treatment with pasireotide LAR or octreotide LAR alone in patients with acromegaly and hyperprolactinemia.Methods: Patients with acromeg...

Octreotide LAR (SMS-LAR) is available in 10, 20 and 30 mg dosing. The relation-ship between SMS-LAR starting dose and GH, IGF-I and symptoms was exam-ined. The Observational Acromegaly Study on Impact of Sandostatin LAR (OASIS) collects data on GH, IGF-I, symptoms, safety and tolerability in recently diagnosed acromegalic patients. Data are collected under normal practice conditions over 12 mos. Eight hundred and sixty patients from 138 centers in 23 countries are enrolled; 35...

Background: Pasireotide has proven efficacy in acromegaly and CD, although pasireotide-associated hyperglycaemia occurs in some patients. This Phase IV, randomized, open-label study investigated optimal management of pasireotide-associated hyperglycaemia uncontrolled by metformin/oral antidiabetic therapy (OAD) [NCT02060383].Methods: Adults with acromegaly or CD were enrolled and treated with long-acting pasireotide 40 mg/28 days or subcutaneous pasireot...

Introduction: High affinity binding of pasireotide for both sst2 and sst5 leads to its enhanced efficacy in treatment of acromegaly but results in decreased secretion of insulin, incretins (GLP-1 and GIP) and, to a lesser extent, glucagon. Metformin may be a good option in patients with acromegaly experiencing hyperglycaemia with pasireotide as it improves GLP-1 secretion. We analysed data from a 12-month, Phase III, randomised study in medically naï...

Introduction: Pasireotide normalized or reduced UFC in patients with Cushing’s disease in a large, 12-month study. This analysis evaluates the effects of pasireotide on the signs/symptoms of Cushing’s disease according to the degree of UFC control.Methods: Adult patients (n=162) with persistent/recurrent or de novo Cushing’s disease were randomized to pasireotide 600/900 μg s.c. bid. Dose titration (max: 1200 μg...

Introduction: Osilodrosat is a potent oral 11β-hydroxylase inhibitor. During the 24-week, single-arm, open-label period of the Phase III LINC 3 study (NCT02180217), osilodrostat treatment demonstrated rapid, sustained reduction in mean urinary free cortisol (mUFC) in most Cushing disease (CD) patients. In the subsequent 8-week, double-blind, randomized-withdrawal phase, a significantly higher proportion of patients receiving osilodrostat maintained normal mUFC at week (W)...

Introduction: In a Phase II study, osilodrostat, a potent oral 11β-hydroxylase inhibitor, normalized mean urinary free cortisol (mUFC) in most patients with CD. We report the efficacy and safety of osilodrostat in a large CD patient population (NCT02180217).Methods: In this study, open-label osilodrostat was initiated at 2 mg bid in 137 adults with CD and mUFC > 1.5 × ULN, with dose adjustments every 2 weeks (range 1–30 mg bid) up to ...

Introduction: In a Phase III trial, pasireotide LAR was significantly superior (P=0.007) to octreotide LAR at providing biochemical control at 12 months in medically naïve acromegaly patients (post-pituitary surgery or de novo). Inadequately controlled patients (GH≥2.5 μg/l and/or IGF-1>ULN) at the end of core study were eligible for switching therapy (crossover extension). Reported here are efficacy results up to 12 months and safety resu...