Searchable abstracts of presentations at key conferences in endocrinology

ea0037ep808 | Pituitary: clinical | ECE2015

Trial design of phase IIIb, open-label, single arm study to evaluate efficacy and safety of pasireotide LAR in patients with inadequately-controlled acromegaly despite treatment with first-generation somatostatin analogues

Gadelha Monica R , Pedroncelli Alberto M , Kandra Albert , Resendiz Karina Hermosillo , Colao Anna Maria

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...

ea0041ep901 | Pituitary - Clinical | ECE2016

High burden of illness at baseline in patients with uncontrolled acromegaly participating in the PAOLA study

Shimon Ilan , Raverot Gerald , Coculescu Mihail , Bolanowski Marek , Colao Annamaria , Kandra Albert , Resendiz Karina Hermosillo , Pedroncelli Alberto M , Gadelha Monica

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...

ea0037gp.19.09 | Pituitary–Acromegaly | ECE2015

Management of pasireotide-induced hyperglycaemia with proactive monitoring and early intervention: key learnings from the phase III, 24-week PAOLA study

Gadelha Monica R , Brue Thierry , Fleseriu Maria , Shimon Ilan , Resendiz Karina Hermosillo , Kandra Albert , Pedroncelli Alberto M , Colao AnnaMaria

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...

ea0037gp.22.04 | Pituitary–Therapy of Cushing's disease | ECE2015

Long-term (5 years) treatment of Cushing's disease with pasireotide

Petersenn Stephan , Salgado Luiz R , Schopohl Jochen , Portocarrero-Ortiz Lesly , Arnaldi Giorgio , Lacroix Andre , Ravichandran Shoba , Kandra Albert , Bagulho Teresa , Biller Beverly MK

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...

ea0037ep811 | Pituitary: clinical | ECE2015

Ongoing, open-label, multicenter, expanded-access study demonstrating the safety and efficacy of pasireotide sc in patients with Cushing's disease

Salgado Luiz R , Stalla Gunter K , Mazzuco Tania Longo , Geer Eliza B , Pedroncelli Alberto M , Ye Moncy , Kandra Albert , Limumpornpetch Padiporn

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...

ea0041ep887 | Pituitary - Clinical | ECE2016

Long-term (19-month) control of urinary free cortisol with osilodrostat in patients with Cushing’s disease: results from an extension to the LINC-2 study

Pivonello Rosario , Hatipoglu Betul , Bertagna Xavier , Fleseriu Maria , Molitch Mark E , Shimizu Chikara , Tanaka Tomoaki , Shimatsu Akira , Biller Beverly M K , Ravichandran Shoba , Kandra Albert , Sauter Nicholas , Young Jacques

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...

ea0037ep810 | Pituitary: clinical | ECE2015

Pasireotide long-acting release maintains biochemical control in patients with acromegaly: results from the extension of randomised, Phase III, PAOLA study

Colao Anna Maria , Bronstein Marcello D , Brue Thierry , Coculescu Mihail , Marinis Laura De , Fleseriu Maria , Guitelman Mirtha A , Pronin Vyacheslav , Raverot Gerald , Shimon Ilan , Fleck Juergen , Kandra Albert , Pedroncelli Alberto M , Gadelha Monica R

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/...