Endocrine Abstracts

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Background: Osilodrostat is an oral inhibitor of 11β-hydroxylase (CYP11B1), the enzyme that catalyses the final step in cortisol biosynthesis. In a 22-week, phase II study, osilodrostat treatment normalised mean urinary free cortisol (mUFC) in 78.9% (15/19) of patients with uncontrolled Cushing’s disease and was well tolerated. The present phase 3 study is designed to confirm the safety and efficacy of osilodrostat in patients with uncontrolled Cushing’s disease...

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...

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...

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...

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...

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 &...