Searchable abstracts of presentations at key conferences in endocrinology

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...

ea0081p413 | Pituitary and Neuroendocrinology | ECE2022

Osilodrostat provides sustained clinical benefits and improves health-related quality of life in patients with cushing’s disease: results from the Phase III LINC 4 study

Feelders Richard , Gadelha Monica , Bex Marie , Witek Przemysław , Belaya Zhanna , Yu Yerong , Turcu Adina F. , Heaney Anthony , Auchus Richard , Piacentini Andrea , Pedroncelli Alberto , Snyder Peter J.

Background: Cushing’s disease (CD) is associated with hypercortisolism-induced cardiovascular morbidity and mortality and impaired patient quality of life (QoL). We report long-term effects of osilodrostat (potent 11β-hydroxylase inhibitor) on cardiovascular/metabolic-related risk factors, physical features of hypercortisolism and QoL in CD patients following the core and extension phases of the LINC 4 study (NCT02697734).Methods: LINC 4 compri...

ea0090p696 | Pituitary and Neuroendocrinology | ECE2023

In the Phase III studies LINC 3 and LINC 4, osilodrostat was effective and well tolerated in patients of Asian and non-Asian origin with Cushing’s disease

Akira Shimatsu , Biller Beverly M.K. , Fleseriu Maria , Pivonello Rosario , Jig Lee Eun , Rattana Leelawattana , Hee Kim Jung , Walia Rama , Yu Yerong , Liao Zhihong , Piacentini Andrea , Pedroncelli Alberto , Snyder Peter

Introduction: Osilodrostat (oral 11β-hydroxylase inhibitor) demonstrated rapid, sustained cortisol normalisation in Phase III studies (LINC 3, NCT02180217; LINC 4, NCT02697734) in patients with Cushing’s disease (CD). Relative osilodrostat bioavailability is ~20% higher in Asian patients than other ethnicities; body weight is not a major determinant of this difference. This analysis of LINC 3 and LINC 4 evaluated osilodrostat efficacy and safety in Asian and non-Asia...

ea0073oc3.1 | Oral Communications 3: Pituitary and Neuroendocrinology | ECE2021

Osilodrostat is an effective and well-tolerated treatment for Cushing’s Disease (CD): Results from a Phase III, multicentre, randomized, double-blind study with an initial placebo-controlled phase (LINC 4)

Gadelha Monica , MarieBex , Feelders Richard , Heaney Anthony , Auchus Laviola , Gilis-Januszewska Laviola , Witek Przemyslaw , Zhanna Belaya , Zhihong Liao , Chen Ku Witek , Carvalho Davide , Roughton Michael , Wojna Judi , Hofstetter Georg , Pedroncelli Alberto , Snyder Peter

IntroductionOsilodrostat, a potent, oral 11β-hydroxylase inhibitor, normalized mean urinary free cortisol (mUFC) in most patients with CD during a Phase III, randomized-withdrawal study. We now report findings from a Phase III study of osilodrostat in patients with CD that featured an initial double-blind, randomized, placebo-controlled period (LINC 4; NCT02697734).MethodsAdults with CD (mUFC > 1.3 &...