Endocrine Abstracts

Background: Long-term treatment with dopamine agonists (DAs) is considered to be the first-choice therapy for prolactinomas. According to current guidelines DAs can be safely withdrawn in patients with negative pituitary MRI and stable normalization of prolactin levels for at least 3 years. On the other hand, recent studies have shown an increased risk for valvular heart disease in patients with Parkinson’s disease treated with high doses of cabergoline. The aim of this s...

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...

Background: Experimental studies have demonstrated that prolactin is a potent immunomodulator influencing both humoral and cell-mediated responses. In accordance with these data, our retrospective studies revealed higher prevalence of autoimmune thyroid diseases in prolactinoma patients compared to general population.Design: A prospective cross-sectional case–control study was carried out in a single tertiary referral centre.A...

Background: Injectable somatostatin receptor ligands (SRLs) are currently the most widely used therapy for acromegaly. Oral octreotide capsules (OOC) are a potential therapy for acromegaly; the safety and efficacy were evaluated in the CHIASMA OPTIMAL pivotal study (Samson et al. ENDO 2020). As reported, mean IGF-I levels of the OOC group were maintained within normal range at end of treatment in all patients. However, some patients may not respond to OOC treatment (2...

Background: Oral octreotide capsules (OOC) are a treatment option for patients with acromegaly in the United States who have previously responded to injectable somatostatin receptor ligands (iSRLs, octreotide or lanreotide). In previous phase 3 studies, the safety of OOC was shown to be consistent with iSRLs, without dose-dependent adverse reactions. In the double-blind, placebo-controlled period (DPC) of the CHIASMA OPTIMAL trial (NCT03252353), patients were randomized to twi...

Objective: The phase 3 CHIASMA OPTIMAL study assessed efficacy and safety of oral octreotide capsules (OOC) in patients with acromegaly controlled on injectable somatostatin receptor ligands (SRLs). Sensitivity analyses were conducted for efficacy endpoints using two methods of imputation (i.e., the process of replacing clinical data with substitution values) to address missing data points due to some subjects reverting back to their prior injectable SRL treatment.<p class...