Endocrine Abstracts

Background: Somatostatin analogues are the most widely used medical treatment in acromegaly. The available long-acting formulations are administered parenterally (i.m. or deep s.c. injections). Results of a multicentre, baseline controlled, phase 3 study have recently showed that octreotide capsules are an effective and safe treatment in acromegaly. The Treatment Satisfaction Questionnaire for Medication (TQ15M), assessed in the phase 3 study, as exploratory endpoint, compared...

Introduction: Injectable somatostatin analogues (SRLs) are the standard medical management of acromegaly. Injection site adverse reactions reported for parenteral SRLs were examined in the literature and in the FDA Adverse Events Reporting System (AERS), and compared to the respective drug labels.Methods: PubMed was searched using criteria: period 1995–2013, drugs – octreotide (Sandostatin®), lanreotide (Somatuline®</s...

Background: Many patients with acromegaly report limitations of long-acting somatostatin receptor ligand (SRL) injections, including ongoing disease symptoms near cycle-end and injection-site pain. Oral octreotide capsules (OOC) may provide an alternative to monthly injections. The phase 3 CHIASMA OPTIMAL study assessed efficacy and safety of OOC in patients with acromegaly controlled on injectable SRLs.Methods: A multinational, randomized, placebo-contr...

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: Patients with acromegaly responding to injectable somatostatin receptor ligands (SRL) are often treated for decades without deterioration of biochemical response (except for routine fluctuations in IGF-I control), unless there are changing clinical circumstances such as persistent or recurrent tumor growth. Oral octreotide capsules (OOC) have been formulated as a potential therapy for acromegaly and the safety and efficacy was evaluated in the CHIASMA OPTIMAL pivot...

Background: Most patients responding to injectable somatostatin receptor ligands exhibit IGF-I variability around the upper limit of normal (ULN) during long-term follow up. These fluctuations are thought to result from assay variability, nutrition, comorbid conditions, concomitant medications and other unknown factors. The magnitude and factors affecting this variability arenot well understood in patients with acromegaly treated with injectable SRLs.Met...

Background: Distinguishing non-specific signs/symptoms of acromegaly from treatment-emergent adverse events (TEAEs) in patients treated with somatostatin receptor ligands has proven difficult given limited data from placebo-controlled studies. The CHIASMA OPTIMALstudy provides a novel data set to evaluate the incidence of adverse events (AEs) in patients randomized to oral octreotide capsules (OOC) or placebo.Methods: A multinational, randomized, placebo...

Background: Data on the impact of withdrawal from long-acting somatostatin receptor ligand (SRL) injections on disease activity in patients with acromegaly are limited. The CHIASMA OPTIMAL study assessed the efficacy and safety of oral octreotide capsules (OOC) in adult patients with acromegaly responding to SRL injections. The placebo arm of this study allowed for assessment of acromegaly activity in patients after withdrawal from SRL treatment.Methods:...

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...

Background: Injectable somatostatin receptor ligands (SRLs) are the most widely used therapy to control acromegaly. Oral octreotide capsules (OOC) have been formulated as a potential therapy for this disorder and the efficacy and safety was evaluated in the CHIASMA OPTIMAL prospective phase 3 study in patients with acromegaly who were controlled on injectable SRL treatment of varying doses (Samson et al. ENDO 2020).Methods: Patients with confirm...