Searchable abstracts of presentations at key conferences in endocrinology

ea0081p405 | Pituitary and Neuroendocrinology | ECE2022

Impact of urinary and late-night salivary cortisol levels on clinical signs of hypercortisolism and quality of life in patients with Cushing’s disease treated with osilodrostat

Newell-Price John , Fleseriu Maria , Pivonello Rosario , Feelders Richard , Lacroix Andre , Auchus Richard , Piacentini Andrea , Pedroncelli Alberto , M.K. Biller Beverly

Background: 24-h mean urinary free cortisol (mUFC) and late-night salivary cortisol (LNSC) levels are complementary parameters recommended for screening and monitoring treatment response in patients with Cushing’s disease (CD). In the published core period of the Phase III LINC 3 study (NCT02180217), therapy with osilodrostat (potent oral 11β-hydroxylase inhibitor) produced rapid, sustained reductions in mUFC and LNSC alongside improvements in clinical signs of hyper...

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...

ea0090p402 | Pituitary and Neuroendocrinology | ECE2023

Treatment Patterns in Acromegaly: Analysis of Real-World US Insurance Claims from the MarketScan® Database

Brue Thierry , Fleseriu Maria , Barkan Ariel , Duquesne Edouard , Houchard Aude , del Pilar Schneider Maria , Ribeiro-Oliveira Antonio , Melmed Shlomo K.

Background: Medical treatment for acromegaly (characterized by excess growth hormone [GH] production) includes somatostatin receptor ligands (SRLs), dopamine agonists (DAs), and GH receptor antagonists (GHRAs). However, recent real-world United States (US) treatment evaluations are few. We present treatment patterns for patients receiving medications for acromegaly (1/1/2010–31/7/2022).Methods: De-identified data were extracted from MarketScan&...

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...

ea0032p853 | Pituitary – Clinical (<emphasis role="italic">Generously supported by IPSEN</emphasis>) | ECE2013

Evaluation of late-night salivary cortisol during a Phase III study with pasireotide in patients with Cushing's disease

Newell-Price John , Petersenn Stephan , Pivonello Rosario , Findling James , Fleseriu Maria , Trovato Andrew , Hughes Gareth , Ligueros-Saylan Monica , Biller Beverly

Introduction: Generously supported by IPSEN)-->Measurement of salivary cortisol is a simple, convenient, accurate and reproducible technique with potential value during the diagnosis/management of hypercortisolism. Current analysis evaluates changes in late-night salivary cortisol (LNSC) during pasireotide treatment in patients with Cushing’s disease (CD).Methods: A 12 m, Phase III study enrolled 162 adult...

ea0056p861 | Pituitary - Clinical | ECE2018

An open-label, multicentre, single-arm, expanded-access study of subcutaneous (s.c.) pasireotide in patients with Cushing’s disease (CD)

Fleseriu Maria , Iweha Chioma , Salgado Luiz , Mazzuco Tania Longo , Patino Heather , Campigotto Federico , Maamari Ricardo , Limumpornpetch Padiporn

Introduction: Pasireotide sc has a proven favourable efficacy and safety profile in CD patients, as shown in clinical trials. Here, we report safety and efficacy results from an expanded-access study designed to allow CD patients to receive pasireotide until regulatory approval for commercial use and reimbursement was obtained in their country.Methods: Pasireotide-naïve adults with CD (mean 24-hour urinary free cortisol [mUFC; of three samples] exce...

ea0073pep8.5 | Presented ePosters 8: Pituitary and Neuroendocrinology | ECE2021

Osilodrostat provides sustained control of urinary free cortisol in patients with Cushing’s disease: final results from a prospective, open-label study (LINC 2)

Fleseriu Maria , Biller Beverly , Bertherat Jerome , Young Jacques , Arnaldi Giorgio , O’Connell Paul , Izquierdo Miguel , Pedroncelli Alberto , Pivonello Rosario

IntroductionThe oral 11β-hydroxylase inhibitor, osilodrostat, normalized mean urinary free cortisol (mUFC) in 79% (15/19) of patients with Cushing’s disease at the end of the 22-week core LINC 2 study. Long-term efficacy and safety data following an optional extension phase are reported here.MethodsPatients with clinical benefit at week 22 could continue receiving osilodrostat during the extension; ...

ea0090p408 | Pituitary and Neuroendocrinology | ECE2023

Pooled analysis from two osilodrostat Phase III studies in Cushing’s disease (LINC 3 and LINC 4): Clinical improvements according to urinary and late-night salivary cortisol levels

Newell-Price John , Fleseriu Maria , Pivonello Rosario , Feelders Richard , Gadelha Monica , Lacroix Andre , Witek Przemysław , Heaney Anthony , Piacentini Andrea , Pedroncelli Alberto , Biller Beverly M.K.

Introduction: In two Phase III studies (LINC3, NCT02180217; LINC4, NCT02697734), osilodrostat, (potent oral 11β-hydroxylase inhibitor), provided rapid, sustained reductions in mean urinary free cortisol (mUFC) and late-night salivary cortisol (LNSC), alongside improvements in clinical signs of hypercortisolism and health-related quality of life (HRQoL), in Cushing’s disease (CD) patients. mUFC and LNSC are recommended for monitoring treatment response. We assessed wh...

ea0090p432 | Pituitary and Neuroendocrinology | ECE2023

Design of the foresiGHt Trial: A Multicenter, Randomized, Placebo- and Active-Controlled Trial to Compare Once-Weekly Lonapegsomatropin to Placebo and Daily Somatropin in Adults with Growth Hormone Deficiency (GHD)

Gilis-Januszewska Aleksandra , Fleseriu Maria , Otto Jorgensen Jens , CJ Yuen Kevin , Hoybye Charlotte , Mao Meng , Kang Jennifer , Song Wenjie , Komirenko Allison , Shu Aimee , Beckert Michael

Background: Adult GHD results from insufficient growth hormone (GH) secretion from the anterior pituitary gland and may represent either a continuation of childhood-onset GHD or GHD acquired during adulthood. Clinically, adult GHD is associated with central adiposity, decreased lean muscle mass, increased fat mass, decreased bone mineral density, and reduced quality of life. Current standard of care consists of GH replacement via daily injections. Lonapegsomatropin (SKYTROFA; ...