Searchable abstracts of presentations at key conferences in endocrinology

ea0031oc5.2 | Pituitary and neoplasia | SFEBES2013

The role of microRNA miR-34a in the regulation of aryl hydrocarbon receptor interacting protein

Denes Judit , Kasuki Leandro , Trivellin Giampaolo , Gadelha Monica , Korbonits Marta

Germline mutations in the aryl hydrocarbon receptor interacting protein (AIP) gene predispose to early onset pituitary adenoma, with a preponderance of somatotrophinomas. Patients harbouring an AIP mutation respond poorly to somatostatin analogue (SSA) treatment. On the other hand, a subset of sporadic somatotrophinomas with no AIP mutations show low AIP protein expression and exhibit a decreased response to SSA treatment as well. microRNAs are small...

ea0063gp57 | Acromegaly and GH | ECE2019

Biochemical control was sustained with long-acting pasireotide in patients with uncontrolled acromegaly over continued treatment with first-generation somatostatin analogues (SSAs): Results from the extension of phase 3b, open-label study

Gadelha Monica , Colao Annamaria , Bex Marie , Mukherjee Rishav , Bourad Catherine , Maamari Ricardo , Raverot Gerald

Background: In a phase 3b, open-label study (NCT02354508) assessing efficacy and safety of long-acting pasireotide in patients with uncontrolled acromegaly after ≥3 months of treatment with first-generation SSAs, 18/123 (15%) patients achieved the primary endpoint of mean growth hormone (mGH) <1.0 μg/l and insulin-like growth factor-1 (IGF-1) <ULN (upper limit of normal) at week 36. Here, we present the results from the extension phase of this study.<p c...

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...

ea0032p867 | Pituitary – Clinical (<emphasis role="italic">Generously supported by IPSEN</emphasis>) | ECE2013

Real world data in acromegaly – a retrospective chart audit

Ferone Diego , Forsythe Anna , Ludlam William , Rondena Roberta , Thomas Cherry , Gadelha Monica

Introduction: The ideal strategy and the role of the different therapeutic options in acromegaly remain unclear. This research focuses on observing treatment options, and the respective level of disease control in acromegaly.Methods: A retrospective chart audit was conducted in US, France, Italy, and Brazil (September 2012). 97 endocrinologists completed structured case report forms for the 4 most recently-seen patients (two with somatostatin analogues (...

ea0081p432 | Pituitary and Neuroendocrinology | ECE2022

A systematic literature review to evaluate extended dosing intervals in the pharmacological management of acromegaly

Fleseriu Maria , Zhang Zhaoyun , Hanman Kate , Haria Keval , Houchard Aude , Khawaja Sheila , Ribeiro-Oliveira Antonio , Gadelha Monica

Background: Acromegaly is a rare disorder characterized by excess growth hormone (GH) and insulin-like growth factor 1 (IGF-1). Extended dosing intervals (EDIs) of pharmacological treatments may reduce patient burden and costs compared with standard dosing. This systematic literature review (SLR) investigated treatment of acromegaly at EDIs.Methods: MEDLINE/Embase/the Cochrane Library (2001–June 2021) and key congresses (2018–2021) were searche...

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...

ea0035p905 | Pituitary Clinical (<emphasis role="italic">Generously supported by IPSEN</emphasis>) | ECE2014

Effect of pasireotide on GH, IGF1, IGFBP2, IGFBP3, HbA1C and glucose in patients with inadequately controlled acromegaly: exploratory results from a multicentre, randomized, 24-week study (PAOLA)

Schmid Herbert , Brue Thierry , Colao Annamaria , Gadelha Monica , Shimon Ilan , Kapur Karen , D'Amato Lisa , Pedroncelli Alberto , Fleseriu Maria

Background: The PAOLA study assessed the efficacy/safety of pasireotide LAR vs continued treatment with octreotide LAR/lanreotide Autogel in patients with inadequately controlled acromegaly. An exploratory objective was to measure changes in various associated biomarkers, including IGF1 and IGFBP2 (released from white fat cells and known to prevent insulin resistance), glucose and HbA1c.Methods: Adult patients (GH >2.5 μg/l and IGF1 >1.3&#21...

ea0081rc7.6 | Rapid Communications 7: Pituitary and Neuroendocrinology 2 | ECE2022

Long-term results from the Phase III LINC 4 study: Osilodrostat maintained normal mean urinary free cortisol in patients with Cushing’s disease, with a favourable safety profile

Gadelha Monica , Snyder Peter J , Witek Przemysław , Bex Marie , Belaya Zhanna , Turcu Adina F , Feelders Richard , Heaney Anthony , Paul Michaela , Pedroncelli Alberto , Auchus Richard

Background: Osilodrostat (potent oral 11β-hydroxylase inhibitor) provided rapid normalisation of mean urinary free cortisol (mUFC) in Cushing’s disease (CD) patients during the 48-week (W) core period of LINC 4 (NCT02697734) and was well tolerated. We report long-term efficacy and safety results from the LINC 4 core and extension phases.Methods: 73 adults with CD and mUFC >1.3 upper limit of normal (ULN) were enrolled. LINC 4 comprised a 12...