Endocrine Abstracts

Background: Oral octreotide capsules (OOC) are approved in the United Sates for long-term maintenance treatment in acromegaly patients who have previously responded to and tolerated injectable somatostatin analogs (SSAs, octreotide or lanreotide). Injectable SSAs are also approved and the standard of care in the treatment of carcinoid syndrome associated with neuroendocrine tumors (NET). Compared with acromegaly, patients with NET can require higher average doses of injectable...

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: Oral octreotide capsules (OOC) are a treatment option for patients with acromegaly in the United States. The MPOWERED trial (NCT02685709) showed that OOC were noninferior to injectable somatostatin receptor ligands (iSRLs; octreotide or lanreotide) in maintenance of biochemical control in patients previously responding to both treatments, as well as demonstrated improvements in patient-reported outcomes among patients receiving OOC.Objective:...

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...

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...