Endocrine Abstracts

Introduction: Osilodrostat is a potent oral 11β-hydroxylase inhibitor currently in Phase III clinical development for the treatment of Cushing’s syndrome (CS). The key pharmacokinetic (PK) properties, drug–drug interactions (DDIs), and population PK findings for osilodrostat in humans are summarized.Methods: Osilodrostat PK has been characterized in nine Phase I studies (healthy subjects and subjects with hepatic or renal impairment), two ...

Introduction: The present study is designed to evaluate the efficacy and safety of pasireotide-long-acting release (LAR) in patients with acromegaly inadequately controlled after ≧3 mo treatment with the maximal approved doses of first-generation SSAs.Methods: Phase IIIb, multicentre, single-arm, open-label study.Patients: Adults (N~112) with inadequately controlled acromegaly (mean GH>1 μg/l and IGF-1>1.3xULN) desp...

Background: The Phase III PAOLA study assessed the efficacy and safety of pasireotide LAR versus continued treatment with octreotide LAR or lanreotide Autogel in patients with uncontrolled acromegaly. The current analysis investigated overall baseline characteristics and response rates to pasireotide according to co-morbidities.Methods: Patients were classified into five groups of co-morbidities related to acromegaly: glucose- (n=104), endocrine...

Introduction: In PAOLA study, pasireotide showed superior efficacy over continued treatment with octreotide/lanreotide in patients with inadequately-controlled acromegaly; 64% of patients receiving pasireotide long-acting release (LAR) reported hyperglycaemia-related adverse events. Pasireotide has been shown to inhibit insulin secretion. The aim of this exploratory analysis was to investigate the effect of timing of antidiabetic medication (ADM) intervention on the fasting pl...

Introduction: Acromegaly is associated with significant morbidity and reduced quality of life. A robust clinical programme (14 trials) established pasireotide as an effective second-generation somatostatin receptor ligand for the treatment of various endocrine conditions, including acromegaly. Patients who completed a previous pasireotide trial and continued to receive clinical benefit, according to the parent study investigator, could continue treatment in the B2412 rollover ...

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...

Background: Pasireotide (Signifor®), a multireceptor-targeted somatostatin analogue, was initially approved in Europe and the USA in 2012 for treating adult patients with Cushing’s disease for whom surgery is not an option/has failed. This ‘expanded-access’ study allowed patients to receive pasireotide until regulatory approval was obtained in their country, and collected further safety/efficacy data. Here we report an interim analysis of this on...

Introduction: The PAOLA study in patients with inadequately-controlled acromegaly (n=198) demonstrated superior efficacy of pasireotide long-acting release (LAR; 40 mg/60 mg) in biochemical control (GH <2.5 μg/l and normalized IGF-1) vs continued treatment with octreotide LAR 30 mg/lanreotide Autogel 120 mg (15.4% and 20.0% vs 0%). Here we report preliminary data from the extension phase of PAOLA at wk28.Methods: Pasireotide-LAR (40 mg/...

Acromegaly is a disorder characterized by overproduction of growth hormones (GH), which causes tissue growth in the body and comorbidities and symptoms. While prior studies examined comorbidities commonly associated with acromegaly, few have long follow-up periods necessary to characterize the long-term comorbidity profile of patients with acromegaly. There is limited literature on real-world treatment patterns of patients with acromegaly. This study describes the long-term pr...

Acromegaly is a rare disorder characterized by the overproduction of growth hormone (GH) and elevated insulin-like growth factor-1 (IGF1). While some studies have investigated the potential associations between biochemical control (i.e., normalization of IGF-1 and/or GH) and comorbidities/symptoms, few studies have long-term follow-up. This study assessed the association between biochemical control and selected comorbidities/symptoms in patients with acromegaly using real worl...