Searchable abstracts of presentations at key conferences in endocrinology

ea0041gp16 | Adrenal (1) | ECE2016

Increased morbidity and hospital admissions in patients with adrenal insufficiency

Stewart Paul M , Biller Beverly MK , Marelli Claudio , Gunnarsson Candace , Ryan Michael , Johannsson Gudmundur

Introduction: Patients with adrenal insufficiency (AI) (primary (PAI), secondary to pituitary disease (PIT) and congenital adrenal hyperplasia (CAH)) have reduced life expectancy with reported standardized mortality ratios of ~2:1 but given the rarity of AI, the underlying explanation remains largely unknown.Objective: To evaluate patient characteristics, prevalence of concomitant conditions and hospitalization incidence in patients with AI compared to a...

ea0041gp153 | Pituitary - Clinical | ECE2016

Once-monthly injection of pasireotide LAR reduces urinary free cortisol (UFC) levels in patients with Cushing’s disease: Results from a randomised, multicentre, phase III trial

Newell-Price John , Petersenn Stephan , Biller Beverly M K , Roughton Michael , Ravichandran Shoba , Lacroix Andre

Background: Twice-daily formulation of pasireotide, a pituitary-directed therapy, is approved for treatment of Cushing’s disease. Here we present data from a phase III study designed to evaluate the more convenient once-monthly long-acting release (LAR) formulation of pasireotide (approved for acromegaly) in patients with Cushing’s disease.Methods: Patients with persistent, recurrent, or de novo Cushing’s disease (not candidates for surger...

ea0037gp.01.02 | Adrenal | ECE2015

Defining and exploring the excessive healthcare burden of adrenal insufficiency

Stewart Paul , Biller Beverly M K , Marelli Claudio , Gunnarsson Candace , Ryan Michael , Johannsson Gudmundur

Introduction: The clinical outcome of patients with adrenal insufficiency (AI) has been shown to be less favorable than previously thought. Clinical studies have shown increased mortality, reduced cardiovascular and skeletal health and compromised quality of life, but the impact of this upon healthcare burden is unknown. This research utilised real-world evidence to compare comorbidities, healthcare utilization and expenditures in patients with AI.Method...

ea0070aep749 | Pituitary and Neuroendocrinology | ECE2020

Pregnancy outcomes in women receiving growth hormone therapy enrolled in NordiNet international outcome study (IOS) and American Norditropin Studies: Web Enabled Research (ANSWER Program)

Biller Beverly , Höybye Charlotte , Camilla Birkegård Anna , Pietropoli Alberto , Weber Matthias

Recombinant human growth hormone (GH) is not indicated for use during pregnancy and in women of childbearing potential not using contraception. Nonetheless, in clinical practice, some women taking GH replacement conceive during treatment and many continue GH during their pregnancy. Here we report data on GH-treated women enrolled in two complementary, international, non-interventional registry studies, NordiNet IOS (NCT00960128; 2006–2016) and ANSWER (NCT01009905; 2002&#...

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...

ea0081ep673 | Pituitary and Neuroendocrinology | ECE2022

Growth hormone (GH) replacement therapy (GHRT) in patients with adult GH deficiency (AGHD) aged ≥60 years: data from NordiNet® IOS and the ANSWER Program

M. Weber Matthias , B. Gordon Murray , Hoybye Charlotte , H. Olsen Anne , Kelepouris Nicky , Nedjatian Navid , M.K. Biller Beverly

Introduction: There are limited data on the effectiveness and safety of GHRT in older patients with AGHD. We compared real-world GHRT outcomes in older (aged ≥60 years) vs middle-aged (35–<60 years) adults.Methods: NordiNet® IOS (NCT00960128) and ANSWER (NCT01009905) were non-interventional studies investigating long-term effectiveness and safety of GHRT with Norditropin® (somatropin, Novo Nordisk). Safety was assessed in the ful...

ea0063gp53 | Acromegaly and GH | ECE2019

Efficacy and safety of once-weekly somapacitan in adult growth hormone deficiency (AGHD) confirmed in a 53-week REAL-1 trial extension

Johannsson Gudmundur , Gordon Murray , Rasmussen Michael Hojby , Hakonsson Ida Holme , Svaerke Claus , Tahara Shigeyuki , Takano Koji , Biller Beverly MK

Background: Following the 34-week, double-blind, placebo-controlled main phase of REAL-1 (NCT02229851), this open-label trial extension evaluated efficacy and safety of somapacitan in patients aged 23–79 years with AGHD, for an additional 52 weeks (8 weeks’ dose titration followed by 44 weeks’ fixed dose treatment; 86 weeks’ treatment in total).Methods: Patients completing the main trial entered the extension: 1) somapacitan-treated p...

ea0049ep1010 | Pituitary - Clinical | ECE2017

Hypertension, acromegaly and pegvisomant treatment: Experience from ACROSTUDY

Vila Greisa , Jan vanderLely Arrt , Neggers Sebastian , Luger Anton , Webb Susan , Biller Beverly , Jonsson Peter , Hey-Hadavi Judith

Introduction: Hypertension (HTN) is a major cardiovascular (CV) risk factor and independent predictor of the increased mortality in patients with acromegaly. Surgical cure of acromegaly is associated with improvement in blood pressure (BP) levels, however little is known on the effect of pegvisomant (PEGV) treatment on HTN.Methods/design: ACROSTUDY is an open-label, international, prospective, non-interventional study monitoring the long-term safety of P...