Endocrine Abstracts

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...

Background: In a large 12-month Phase III study, pasireotide led to rapid and sustained decreases in UFC and provided clinical benefit in patients with Cushing’s disease. Here, we report data following an open-label, open-ended extension.Methods: 162 patients with persistent/recurrent or de novo Cushing’s disease were randomized in the core study. 58 patients with mean UFC≤ULN or clinical benefit at month 12 entered the extension...

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: 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...

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/...