Searchable abstracts of presentations at key conferences in endocrinology

ea0081ep36 | Adrenal and Cardiovascular Endocrinology | ECE2022

Evaluation of the efficacy of osilodrostat in five patients with Cushing’s syndrome: A single-center study

Hashimoto Naoko , Kono Satomi , Kono Takashi , Akira Shimatsu , Pedroncelli Alberto , Tanaka Tomoaki

Context: Osilodrostat (Osi), a potent inhibitor of 11β-hydroxylase, blocks the conversion of 11-deoxycortisol to cortisol and improves hypercortisolism in patients with Cushing’s syndrome (CS). Here, we report a study evaluating the efficacy of Osi in five non-Cushing’s disease (CD) CS patients treated with Osi in Japan.Subjects and Results: Five patients with non-CD CS were treated with Osi at Chiba University [primary disease breakdown: ...

ea0063gp162 | Cushing's | ECE2019

Pharmacokinetics of osilodrostat following single and multiple doses of osilodrostat in healthy subjects and patients with Cushing’s disease

Han Kevin , Tauchmanova Libuse , Atkinson Susan , Darstein Christelle , Zhang Xinrui , Combes Francois Pierre , Pedroncelli Alberto M

Introduction: Osilodrostat is a potent oral 11β-hydroxylase inhibitor currently in Phase III clinical development for the treatment of Cushing’s syndrome (CS). The key pharmacokinetic (PK) properties, drug–drug interactions (DDIs), and population PK findings for osilodrostat in humans are summarized.Methods: Osilodrostat PK has been characterized in nine Phase I studies (healthy subjects and subjects with hepatic or renal impairment), two ...

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...

ea0035p885 | Pituitary Clinical (<emphasis role="italic">Generously supported by IPSEN</emphasis>) | ECE2014

Study Design of a Phase II trial of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing's disease

Feelders Richard , Pivonello Rosario , Pedroncelli Alberto , Patino Heather , Ye Moncy , Aout Mounir , Fleseriu Maria

Background: Dopamine and somatostatin receptors on corticotroph pituitary adenomas are targets for medical treatment of Cushing’s disease (CD). Data indicate synergistic effects between pasireotide and cabergoline in improving biochemical control rates and clinical features in patients with CD.Objective: To evaluate safety and efficacy of pasireotide alone or with cabergoline in patients with CD.Methods: Patients: adults with ...

ea0081rc7.5 | Rapid Communications 7: Pituitary and Neuroendocrinology 2 | ECE2022

Osilodrostat therapy improves physical manifestations of hypercortisolism in patients with cushing’s disease: findings from the phase III LINC 3 study

Pivonello Rosario , Fleseriu Maria , Akira Shimatsu , Newell-Price John , Auchus Richard , Feelders Richard , Pedroncelli Alberto , Piacentini Andrea , Biller Beverly MK

Background: Improving physical manifestations of hypercortisolism is an important treatment goal for patients with Cushing’s disease (CD). In the Phase III LINC 3 study (NCT02180217), osilodrostat therapy, a potent oral 11β-hydroxylase inhibitor, rapidly normalised mean urinary free cortisol (mUFC) in most patients with CD and sustained control of mUFC over a median treatment period of 130 weeks (W). Here we describe concomitant improvements in physical manifestation...

ea0081p404 | Pituitary and Neuroendocrinology | ECE2022

Change in androgens and adrenal hormones during long-term osilodrostat treatment in patients with Cushing’s disease: Results from the Phase III, prospective LINC 3 study

Pivonello Rosario , M.K. Biller Beverly , Akira Shimatsu , Newell-Price John , Tabarin Antoine , Vila Greisa , Piacentini Andrea , Pedroncelli Alberto , Fleseriu Maria

Introduction: Osilodrostat decreases cortisol production by inhibiting 11β-hydroxylase, increasing adrenal hormones above the blockade. Here, we describe these effects of osilodrostat and associated adverse events (AEs). The efficacy and safety of osilodrostat in patients with Cushing’s disease (CD) were confirmed in the published Phase III, prospective LINC 3 study (NCT02180217).Methods: 137 patients with CD (mUFC >1.5x upper limit of norm...

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...

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...