Searchable abstracts of presentations at key conferences in endocrinology

ea0037ep804 | Pituitary: clinical | ECE2015

Pharmacokinetic and pharmacodynamic analyses of pasireotide LAR from a randomised, phase III study in patients with inadequately controlled acromegaly

Shen Guoxiang , Darstein Christelle , Resendiz Karina Hermosillo , Hu Ke

Introduction: A 24-week, PhIII, randomised study (PAOLA) demonstrated superior efficacy of pasireotide long-acting release (PAS-LAR; 40 and 60 mg) vs continued treatment with octreotide LAR 30 mg or lanreotide Autogel 120 mg (15.4%, 20.0% vs 0%) at providing biochemical control (GH<2.5 μg/l and normalized IGF-1) in patients with acromegaly inadequately controlled on first-generation somatostatin analogues. Results from PK/PD analyses of PAS-LAR are reported here.<...

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 &gE;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...

ea0035p918 | Pituitary Clinical (<emphasis role="italic">Generously supported by IPSEN</emphasis>) | ECE2014

Pharmacokinetic (PK) and pharmacodynamic (PD) analyses of pasireotide LAR and octreotide LAR: Randomized, double-blind Phase III study in patients with medically naive acromegaly

Shen George , Darstein Christelle , Resendiz Karina Hermosillo , Wang Yanfeng , Hu Ke

Introduction: A recent 12-month randomized, double-blind study showed that pasireotide LAR was superior to octreotide LAR at providing biochemical control (GH and IGF1) in medically naïve patients with acromegaly. This analysis evaluates the PK/PD of pasireotide and octreotide in these patients.Methods: Patients received pasireotide LAR 40 mg/28 day (n=176) or octreotide LAR 20 mg/28 day (n=182) for 12 m. The relationship between p...

ea0032p906 | Pituitary – Clinical (<emphasis role="italic">Generously supported by IPSEN</emphasis>) | ECE2013

Treatment with pasireotide LAR normalizes prolactin levels in patients with acromegaly and hyperprolactinemia: randomized, double-blind, 12-month, phase III study

Colao Annamaria , Freda Pamela , Gu Feng , Resendiz Karina Hermosillo , Ruffin Matthieu , Chen YinMiao , Bronstein Marcello

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...

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...