Searchable abstracts of presentations at key conferences in endocrinology

ea0063gp166 | Obesity (1) | ECE2019

Results from the phase 3 multicenter SONICS study of levoketoconazole: subgroup analysis of Cushing’s syndrome patients with diabetes mellitus

Fleseriu Maria , Pivonello Rosario , Elenkova Atanaska , Salvatori Roberto , Auchus Richard J. , Feelders Richard A. , Geer Eliza B. , Greenman Yona , Witek Przemyslaw , Cohen Frederic , Biller Beverly MK

Background: Cushing’s syndrome (CS) has numerous comorbidities, including diabetes mellitus (DM). Levoketoconazole is a ketoconazole stereoisomer in clinical trials for treatment of CS.Methods: SONICS is a prospective, open-label, phase 3 maintenance-of-benefit study in adults with confirmed CS and mean urinary free cortisol (mUFC) of ≥1.5x upper limit of normal (ULN). Repeated hospitalization due to hyperglycemia or any complication related t...

ea0037ep811 | Pituitary: clinical | ECE2015

Ongoing, open-label, multicenter, expanded-access study demonstrating the safety and efficacy of pasireotide sc in patients with Cushing's disease

Salgado Luiz R , Stalla Gunter K , Mazzuco Tania Longo , Geer Eliza B , Pedroncelli Alberto M , Ye Moncy , Kandra Albert , Limumpornpetch Padiporn

Background: Pasireotide (Signifor®), a multireceptor-targeted somatostatin analogue, was initially approved in Europe and the USA in 2012 for treating adult patients with Cushing’s disease for whom surgery is not an option/has failed. This ‘expanded-access’ study allowed patients to receive pasireotide until regulatory approval was obtained in their country, and collected further safety/efficacy data. Here we report an interim analysis of this on...

ea0056gp205 | Pituitary Clinical | ECE2018

Predictors of response to long-acting pasireotide in patients with Cushing’s disease during a Phase III study

Witek Przemyslaw , Biller Beverly M K , Lacroix Andre , Feelders Richard , Li Yiming , Geer Eliza B , Brue Thierry , Ravichandran Shoba , Tauchmanova Libuse , Roughton Michael , Petersenn Stephan

Introduction: Long-acting pasireotide reduced urinary free cortisol (UFC) in most patients with Cushing’s disease (CD) during a large Phase III study (Lacroix et al. Lancet Diabetes Endocrinol 2018). The analyses presented here explored the impact of baseline characteristics on response to long-acting pasireotide.Methods: 150 patients with persistent, recurrent or de novo CD and mean UFC (mUFC; from three 24-hour samples collected ...

ea0070aep678 | Pituitary and Neuroendocrinology | ECE2020

Levoketoconazole in the treatment of endogenous Cushing’s syndrome: Extended evaluation phase results of the SONICS study

Fleseriu Maria , Auchus Richard J , Greenman Yona , Zacharieva Sabina , Geer Eliza B , Salvatori Roberto , Pivonello Rosario , Feldt-Rasmussen Ulla , Kennedy Laurence , Buchfelder Michael , Biller Beverly M K , Cohen Fredric , Heaney Anthony P

Background: The phase 3, open-label SONICS study of levoketoconazole demonstrated sustained reduction in mean urinary free cortisol (mUFC) in adults with endogenous Cushing’s syndrome (CS). The extended evaluation phase (Ext) of SONICS reported here further assessed long-term safety, tolerability, and benefit/risk of this treatment.Methods: SONICS consisted of dose-titration (150 – 600 mg BID to attain maximally tolerated dose for mUFC normal...