ECE2020 Audio ePoster Presentations Pituitary and Neuroendocrinology (217 abstracts)
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
Artak Labadzhyan 1 , Susan Samson 2 , Lisa Nachtigall 3 , Maria Fleseriu 4 , Mark E Molitch 5 , William Ludlam 6 , Gary Patou 6 , Asi Haviv 6 , Agata Baldys Waligorska 7 , Nienke Biermasz 8 , Peter Trainer 9 , Laurence Kennedy 10 , Shlomo Melmed 1 & Christian J Strasburger 11
1Cedars Sinai Medical Center; 2Baylor College of Medicine; 3MGH Neuroendocrine and Pituitary Center; 4Oregon Health & Science University, Portland, United States; 5Northwestern University, Evanston, United States; 6Chiasma; 7Andrzej Frycz Modrzewski Krakow University; 8LUMC – Endocrinology and metabolisme; 9The Christie NHS Foundation Trust; 10Cleveland Clinic Foundation; 11Charité Campus Mitte
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-controlled study was conducted in 56 adult patients with active acromegaly. Eligible patients had active disease (IGF-1 ≥ 1.3 × ULN after last pituitary surgery) and an average IGF-1 ≤ 1.0 × ULN in response to a stable dose of somatostatin analog injection. Patients were randomized (28/group) to OOC or placebofor 36 weeks, followed by an optional open-label extension for up to 1 year. Safety and tolerability were evaluated based on incidence of AEs, including incidence of new or worsening adverse events of special interest (AESIs).
Results: In this study, the safety profile of OOC was consistent with the known safety profile of injectable octreotide. No new safety signals were detected. Nearly all patients (55/56) experienced a TEAE (28 patients [100.0%] in the OOC group and 27 patients [96.4%] in the placebo group). Thirty-three patients (58.9%) experienced a TEAE considered to be related to study drug by the blinded PI (64.3% of OOC group [18 patients, 40 events] and 53.8% of placebo group [15 patients, 41 events]). TEAEs with an incidence ≥5% that were more common in the OOC group vs placebo group included GI disorders, increased blood glucose, sinusitis, osteoarthritis, and cholelithiasis. TEAEs with an incidence ≥5% that were more common in the placebo group vs OOC group included arthralgia, headache, fatigue, hyperhidrosis, and peripheral swelling. GI disorders were the most common TEAE, reported in 64% of all patients (36/56) and at similar rates between the OOC (68%) and placebo (61%) groups. AESIs (defined as new or worsening signs of acromegaly) were observed in 15 patients (53.6%, 34 events total) in OOC group and in 26 patients (92.9%, 82 events total) in placebo group.
Conclusion: In this study, the safety profile of octreotide capsules was consistent with the known safety profile of injectable octreotide. Most patients receiving octreotide capsules or placebo demonstrated TEAEs, although the profile of most common TEAEs varied between groups. TEAEs observed in the placebo group may be indicative of underlying disease activity. Further analysis may elucidate the difference between treatment related AEs and signs/symptoms of active disease in acromegaly.
Article tools
My recent searches
My recently viewed abstracts
Authors
Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
© Bioscientifica 2024 |
Privacy policy |
Cookie settings
BiosciAbstracts
Bioscientifica Abstracts is the gateway to a series of products that provide a permanent, citable record of abstracts for biomedical and life science conferences.
Find out more