Endocrine Abstracts

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...

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...

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...

Somapacitan is a once-weekly, long-acting growth hormone (GH) derivative approved for the treatment of adult GH deficiency (AGHD). Our objective was to evaluate the effects of somapacitan on glucose metabolism compared with daily GH or placebo in patients with AGHD using data from three previously published phase 3 trials: REAL 1 (NCT02229851), REAL 2 (NCT02382939) and REAL Japan (NCT03075644). REAL 1 was a randomised, placebo-controlled (double-blind) and active-controlled (o...

Introduction: Osilodrosat is a potent oral 11β-hydroxylase inhibitor. During the 24-week, single-arm, open-label period of the Phase III LINC 3 study (NCT02180217), osilodrostat treatment demonstrated rapid, sustained reduction in mean urinary free cortisol (mUFC) in most Cushing disease (CD) patients. In the subsequent 8-week, double-blind, randomized-withdrawal phase, a significantly higher proportion of patients receiving osilodrostat maintained normal mUFC at week (W)...