Endocrine Abstracts

Background: In the 22-week LINC-2 study, osilodrostat (LCI699), a potent oral 11β-hydroxylase inhibitor, normalized urinary free cortisol (UFC) levels in 15 of 19 patients with Cushing’s disease (CD). The most common AEs were nausea, diarrhea, asthenia, and adrenal insufficiency (n=6 each). Here, we report the 31-month efficacy and safety results from LINC-2 extension.Methods: Patients receiving clinical benefit at week 22 could enter ...

Background: Pituitary apoplexy (PitApo) has significant associated-morbidity and its management is not yet standardised.Aim: To describe prevalence and characteristics of PitApo patients in GH deficient (GHD) patients compared with two control populations.Patients and methods: Patients with ‘infarction-apoplexy’ GHD aetiology code were identified from Pfizer International Metabolic Database (KIMS). Baseline characteristic...

Introduction: Generously supported by IPSEN)-->Measurement of salivary cortisol is a simple, convenient, accurate and reproducible technique with potential value during the diagnosis/management of hypercortisolism. Current analysis evaluates changes in late-night salivary cortisol (LNSC) during pasireotide treatment in patients with Cushing’s disease (CD).Methods: A 12 m, Phase III study enrolled 162 adult...

Objective: Our study evaluates the contribution of untreated GHD to the phenotype in controlled CD, by comparing patients with GHD due to CD (n=322) and those with non-functioning pituitary adenoma (NFPA n=748) before and after 3 years of GH treatment.Methods: The patient cohorts were obtained from KIMS (Pfizer International Metabolic Database) and matched for age and gender. Duration between pituitary disease onset and GH start was 9.7 (CD...

Two medical therapies are now available for the treatment of acromegaly. Pegvisomant is a growth hormone (GH) receptor antagonist. Somatostatin analogues, in contrast, act by inhibiting the release of GH from the pituitary. The primary objective of this study was to compare the efficacy of pegvisomant (P) to that of octreotide LAR (LAR) in terms of IGF-1 normalisation. The secondary objective was to compare safety and tolerability between the two treatments.<p class="abste...

IntroductionThe oral 11β-hydroxylase inhibitor, osilodrostat, normalized mean urinary free cortisol (mUFC) in 79% (15/19) of patients with Cushing’s disease at the end of the 22-week core LINC 2 study. Long-term efficacy and safety data following an optional extension phase are reported here.MethodsPatients with clinical benefit at week 22 could continue receiving osilodrostat during the extension; ...

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: 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...

Introduction: Phase II (LINC2, NCT01331239) and Phase III (LINC3, NCT02180217; LINC4, NCT02697734) studies showed that osilodrostat, a potent oral 11β-hydroxylase inhibitor, was an effective long-term treatment for Cushing’s disease patients. In this LINC programme pooled analysis, we examined how dose uptitration and adjustments during long-term maintenance can provide rapid, sustained mean urinary free cortisol (mUFC) control, and minimise AEs.<p class="abstext...

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...