Searchable abstracts of presentations at key conferences in endocrinology

ea0037ep710 | Pituitary: basic and neuroendocrinology | ECE2015

Patient reported outcomes comparing octreotide capsules to somatostatin analogues injections: results from a multicentre, baseline controlled, phase 3 study in acromegaly

Haviv Asi , Patou Gary , Mathias Susan

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...

ea0037ep711 | Pituitary: basic and neuroendocrinology | ECE2015

Parenteral somatostatin analogues: a focus on injection site adverse reactions

Haviv Asi , Kramer Susan , Patou Gary , Tillotson Gary

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...

ea0070oc4.6 | Pituitary and Neuroendocrinology | ECE2020

Results from the phase 3, randomized, double-blind, placebo-controlled OPTIMAL study of oral octreotide capsules in adult patients with acromegaly

Samson Susan , Nachtigall Lisa , Fleseriu Maria , Gordon Murray , Ludlam William , Patou Gary , Haviv Asi , Molitch Mark E , Biermasz Nienke , Strasburger Christian J , Kennedy Laurence , Melmed Shlomo

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...

ea0070aep577 | Pituitary and Neuroendocrinology | ECE2020

Biochemical control of most patients reverting to injectable long-acting somatostatin receptor ligands is achieved after one dose: Results from the phase 3, randomized, double blind, placebo-controlled optimal study

Fleseriu Maria , Samson Susan , Nachtigall Lisa , Labadzhyan Artak , Elenkova Atanaska , Molitch Mark E , Ludlam William , Patou Gary , Haviv Asi , Biermasz Nienke , Strasburger Christian J , Kennedy Laurence , Melmed Shlomo

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...

ea0081oc4.3 | Oral Communications 4: Pituitary and Neuroendocrinology 1 | ECE2022

Long-term efficacy and safety data for oral octreotide capsules in acromegaly: mpowered trial open-label extension phase

Fleseriu Maria , Molitch Mark E , Dreval Alexander , Pokramovich Yulia G , Bondar Irina , Poteshkin Yury E , Macut Djuro P , Obermayer-Pietsch Barbara , Gilgun-Sherki Yossi , Haviv Asi , Biermasz Nienke , Melmed Shlomo , Strasburger Christian J

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:...

ea0081p170 | Pituitary and Neuroendocrinology | ECE2022

Safety comparison of 40- vs 60- mg/day doses of oral octreotide capsules for treatment of acromegaly in the chiasma optimal trial

L. Samson Susan , Nachtigall Lisa B. , Fleseriu Maria , Molitch Mark E. , Giustina Andrea , Haviv Asi , Biermasz Nienke , Kennedy Laurence , Jensterle Mojca , Manning Patrick , Elenkova Atanaska , Melmed Shlomo , Strasburger Christian J.

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...

ea0070aep576 | Pituitary and Neuroendocrinology | ECE2020

Sustained response to treatment with oral octreotide capsules: Results from the phase 3, randomized, double blind, placebo-controlled optimal study

Samson Susan , Nachtigall Lisa , Fleseriu Maria , Baldys Waligorska Agata , Jensterle Mojca , Ur Ehud , Molitch Mark E , Ludlam William , Patou Gary , Haviv Asi , Biermasz Nienke , Kennedy Laurence , Melmed Shlomo , Strasburger Christian J

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...

ea0070aep612 | Pituitary and Neuroendocrinology | ECE2020

IGF-I variability and its association with demographic and clinical characteristics in patients with acromegaly treated with injectable somatostatin receptor ligands (SRLs); results from OPTIMAL, an international prospective phase 3 study

Samson Susan , Nachtigall Lisa , Fleseriu Maria , Ur Ehud , E Molitch Mark , Ludlam William , Patou Gary , Haviv Asi , Gilgun-Sherki Yossi , Biermasz Nienke , Strasburger Christian J , Kennedy Laurence , Melmed Shlomo

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...

ea0070aep613 | Pituitary and Neuroendocrinology | ECE2020

Analysis of adverse events in adult patients with acromegaly receiving oral octreotide capsules: Results from the phase 3, randomized, double-blind, placebo-controlled optimal study

Labadzhyan Artak , Samson Susan , Nachtigall Lisa , Fleseriu Maria , Molitch Mark E , Ludlam William , Patou Gary , Haviv Asi , Baldys Waligorska Agata , Biermasz Nienke , Trainer Peter , Kennedy Laurence , Melmed Shlomo , Strasburger Christian J

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...

ea0070aep668 | Pituitary and Neuroendocrinology | ECE2020

Withdrawal from long-acting somatostatin receptor ligand injections in adult patients with acromegaly: Results from the phase 3, randomized, double-blind, placebo-controlled optimal study

Nachtigall Lisa , Samson Susan , Fleseriu Maria , Bolanowski Marek , E Molitch Mark , Ludlam William , Patou Gary , Haviv Asi , Manning Patrick , Biermasz Nienke , Giustina Andrea , Strasburger Christian J , Melmed Shlomo , Kennedy Laurence

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:...