Searchable abstracts of presentations at key conferences in endocrinology

ea0032p906 | Pituitary – Clinical (<emphasis role="italic">Generously supported by IPSEN</emphasis>) | ECE2013

Treatment with pasireotide LAR normalizes prolactin levels in patients with acromegaly and hyperprolactinemia: randomized, double-blind, 12-month, phase III study

Colao Annamaria , Freda Pamela , Gu Feng , Resendiz Karina Hermosillo , Ruffin Matthieu , Chen YinMiao , Bronstein Marcello

Introduction: Around 20–30% of patients with acromegaly have hyperprolactinemia, which is associated with infertility and gonadal/sexual dysfunction. Current therapy involves somatostatin analogues for GH/IGF1 excess and a dopamine agonist to decrease prolactin levels. The objectives of this analysis were to assess treatment with pasireotide LAR or octreotide LAR alone in patients with acromegaly and hyperprolactinemia.Methods: Patients with acromeg...

ea0032p845 | Pituitary – Clinical (<emphasis role="italic">Generously supported by IPSEN</emphasis>) | ECE2013

Pasireotide LAR and octreotide LAR maintain inhibition of GH and IGF1 in patients with acromegaly: 12-month extension phase of a randomized, double-blind, multicenter, phase III study

Sheppard Michael , Bronstein Marcello , Freda Pamela , Serri Omar , De Marinis Laura , Naves Luciana , Rozhinskaya Liudmila , Hermosillo Resendiz Karina , Ruffin Matthieu , Asubonteng Kobby , Colao Annamaria

Introduction: Pasireotide LAR was significantly superior to octreotide LAR at providing biochemical control in a 12-month trial in 358 medically naïve patients with acromegaly. Patients with clinical benefit or GH <2.5 μg/l and IGF1≤ULN could continue therapy in the extension study.Methods: Patients entering the extension (pasireotide LAR, n=74; octreotide LAR, n=46) were followed up to month 26 (core plus extension)...

ea0032p847 | Pituitary – Clinical (<emphasis role="italic">Generously supported by IPSEN</emphasis>) | ECE2013

Switching patients with acromegaly from octreotide LAR to pasireotide LAR improves biochemical control: crossover extension to a randomized, double-blind, multicenter, Phase III study

Freda Pamela , Fleseriu Maria , van der Lely Aart Jan , Colao Annamaria , Sheppard Michael , Gu Feng , Shen Chiung-Chyi , Gadelha Monica , Farrall Andrew , Hermosillo Resendiz Karina , Ruffin Matthieu , Chen YinMiao , Bronstein Marcello

Introduction: In a Phase III trial, pasireotide LAR was significantly superior (P=0.007) to octreotide LAR at providing biochemical control at 12 months in medically naïve acromegaly patients (post-pituitary surgery or de novo). Inadequately controlled patients (GH≥2.5 μg/l and/or IGF-1>ULN) at the end of core study were eligible for switching therapy (crossover extension). Reported here are efficacy results up to 12 months and safety resu...

ea0099p326 | Pituitary and Neuroendocrinology | ECE2024

A randomised phase 3 trial to assess efficacy and safety of CAM2029, an octreotide subcutaneous depot, in patients with acromegaly

Ferone Diego , Silverstein Julie , Freda Pamela , Katznelson Laurence , Gatto Federico , Kadioglu Pinar , Maffei Pietro , Seufert Jochen , L. Spencer-Segal Joanna , Isaeva Elena , Dreval Alexander , Harrie Maria , Svedberg Agneta , Tiberg Fredrik

Background: Acromegaly is a rare endocrine disorder characterised by excess growth hormone (GH) and insulin-like growth factor 1 (IGF-1) that is associated with significant morbidity and impaired quality of life (QoL). Standard-of-care (SoC) treatments for acromegaly typically require healthcare provider administration, pose a substantial treatment burden, and leave scope for improved disease control. CAM2029, an octreotide subcutaneous depot with ~5x higher bioavailability th...

ea0099ep321 | Pituitary and Neuroendocrinology | ECE2024

An open-label long-term Phase 3 study of CAM2029, an octreotide subcutaneous depot, in patients with acromegaly (ACROINNOVA 2): interim analysis of the ACROINNOVA 1 roll-over patients subgroup

Ferone Diego , Silverstein Julie , Freda Pamela , Katznelson Laurence , Gatto Federico , Kadioglu Pinar , Maffei Pietro , Seufert Jochen , L. Spencer-Segal Joanna , Isaeva Elena , Dreval Alexander , Harrie Maria , Svedberg Agneta , M. Pedroncelli Alberto , Tiberg Fredrik

Background: Acromegaly is a neuroendocrine disorder, characterised by growth hormone (GH) and insulin-like growth factor 1 (IGF-1) overproduction. Persistent biochemical control to minimise adverse effects of prolonged excess GH/IGF-1 is a key treatment goal. CAM2029 is a novel octreotide depot, designed for convenient monthly subcutaneous self-administration, using pre-filled syringes/injection pens. A 24-week Phase 3 trial (ACROINNOVA 1, NCT04076462) evaluated CAM2029 in pat...

ea0099ep322 | Pituitary and Neuroendocrinology | ECE2024

An open-label long-term Phase 3 study of CAM2029, an octreotide subcutaneous depot, in patients with acromegaly (ACROINNOVA 2): interim analysis of patient-reported outcomes

Ferone Diego , Maffei Pietro , Silverstein Julie , L. Spencer-Segal Joanna , Gilis-Januszewska Alexsandra , Doknic Mirjana , Kadioglu Pinar , Freda Pamela , Katznelson Laurence , Fidan Yaylali Guzin , Harrie Maria , Svedberg Agneta , M. Pedroncelli Alberto , Tiberg Fredrik

Background: Significant treatment-related burdens accompany standard-of-care (SoC) therapies for acromegaly, which typically require healthcare-provider administration. CAM2029 is a novel, subcutaneous octreotide depot conveniently self-administered monthly by pre-filled syringe/injection pen. In a 24-week Phase 3 trial of CAM2029 in patients with acromegaly (ACROINNOVA 1, NCT04076462), insulin-like growth factor 1 (IGF-1) response was 72.2% in patients receiving CAM2029 vs 37...

ea0073pep3.2 | Presented ePosters 3: Pituitary and Neuroendocrinology | ECE2021

Safety results from MPOWERED, a phase 3 trial of oral octreotide capsules in adults with acromegaly

Freda Pamela U. , Fleseriu Maria , Dreval Alexander V. , Pokramovich Yulia , Bondar Irina , Isaeva Elena , Huang Wenyu , Molitch Mark E. , Macut Djuro P. , Leonova Nina , Raverot Gerald , Yossi Gilgun-Sherki , Ludlam William H. , Patou Gary , Haviv Asi , Gordon Murray B. , Biermasz Nienke , Melmed Shlomo K. , Strasburger Christian J.

BackgroundInjectable somatostatin receptor ligands (iSRLs) have been a mainstay in acromegaly treatment. Oral octreotide capsules (OOC; MYCAPSSA®) were recently approved in the USA. Results from the placebo-controlled CHIASMA OPTIMAL and open-label CH-ACM-01 studies showed an OOC safety profile consistent with that of iSRLs with no new or unexpected safety signals. Results of the MPOWERED trial have enabled a comparison of OOC safety and ...