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Pasireotide

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https://www.readbyqxmd.com/read/29451701/phase-1b-study-of-pasireotide-everolimus-and-selective-internal-radioembolization-therapy-for-unresectable-neuroendocrine-tumors-with-hepatic-metastases
#1
Hyun S Kim, Walid L Shaib, Chao Zhang, Ganji Purnachandra Nagaraju, Christina Wu, Olatunji B Alese, Zhengjia Chen, Edith Brutcher, Meredith Renfroe, Bassel F El-Rayes
BACKGROUND: Neuroendocrine tumors (NETs) metastasize to the liver. Everolimus and selective internal radioembolization (SIRT) are approved treatments. Pasireotide is a somatostatin analogue with an affinity for somatostatin receptors 1, 2, 3, and 5. Everolimus and pasireotide may potentiate SIRT radiosensitization and inhibit rebound angiogenesis. This study evaluated the safety of pasireotide, everolimus, and SIRT. METHODS: This 3 + 3 phase 1 trial evaluated 3 dose levels of everolimus (2...
February 16, 2018: Cancer
https://www.readbyqxmd.com/read/29398424/pasireotide-does-not-prevent-postoperative-pancreatic-fistula-a-prospective-study
#2
Irmina A Elliott, Amanda M Dann, Razmik Ghukasyan, Lauren Damato, Mark D Girgis, Jonathan C King, O J Hines, Howard A Reber, Timothy R Donahue
BACKGROUND: Pancreatic fistula is a major cause of morbidity after pancreas surgery. In 2014, a single-center, randomized-controlled trial found pasireotide decreased pancreatic fistula rates. However, this finding has not been validated, nor has pasireotide been widely adopted. METHODS: A single-arm study in 111 consecutive patients undergoing pancreatic resection April 2015-October 2016 was conducted. Beginning immediately before surgery, patients received 900 μg subcutaneous pasireotide twice daily for up to seven days...
February 2, 2018: HPB: the Official Journal of the International Hepato Pancreato Biliary Association
https://www.readbyqxmd.com/read/29396758/insulin-sensitivity-and-secretion-and-adipokine-profile-in-patients-with-cushing-s-disease-treated-with-pasireotide
#3
V Guarnotta, G Pizzolanti, A Ciresi, C Giordano
PURPOSE: To evaluate the effect of pasireotide on β-cell and adipose function in patients with Cushing's disease (CD). METHODS: Clinical and hormonal parameters, insulin secretion evaluated by HOMA-β and by the area under the curve (AUC2h) of C-peptide during a mixed meal tolerance test and insulin sensitivity, evaluated by the euglycaemic hyperinsulinaemic clamp, were evaluated in 12 patients with active CD, before and after 6 and 12 months of pasireotide. In addition, a panel of adipokines including leptin (Ob), leptin/leptin receptor ratio (Ob/Ob-R ratio), adiponectin, resistin, visfatin, adipocyte fatty acid binding protein (AFABP) and non-esterified fatty acids (NEFAs) was evaluated at baseline and after 12 months of pasireotide...
February 2, 2018: Journal of Endocrinological Investigation
https://www.readbyqxmd.com/read/29392123/phase-ii-trial-of-som230-pasireotide-lar-in-patients-with-unresectable-hepatocellular-carcinoma
#4
Lynn G Feun, Medhi Wangpaichitr, Ying-Ying Li, Deukwoo Kwon, Stephen P Richman, Peter J Hosein, Niramol Savaraj
Background: A phase II trial of pasireotide was performed to assess its efficacy and safety in advanced or metastatic hepatocellular carcinoma (HCC). Patients and methods: Patients with advanced HCC and Child-Pugh score ≤7 received pasireotide LAR 60 mg intramuscularly every 28 days. Primary endpoint was disease control rate. Secondary endpoints were time to tumor progression, response rate, treatment-related adverse events, and overall survival. Serum insulin growth factor-1 was measured before and after pasireotide...
2018: Journal of Hepatocellular Carcinoma
https://www.readbyqxmd.com/read/29383677/pasireotide-treatment-reduces-cardiometabolic-risk-in-cushing-s-disease-patients-an-italian-multicenter-study
#5
A Albani, F Ferraù, A Ciresi, R Pivonello, C Scaroni, D Iacuaniello, M Zilio, V Guarnotta, A Alibrandi, E Messina, M Boscaro, C Giordano, A Colao, S Cannavo
PURPOSE: Patients with Cushing's disease (CD) experience metabolic alterations leading to increased cardiovascular mortality. Recently, the visceral adiposity index (VAI) has been proposed as a marker of visceral adipose tissue dysfunction (ATD) and of the related cardiometabolic risk. We aimed to evaluate the impact of 12-month pasireotide treatment on cardiometabolic risk in CD patients. METHODS: This is a multicentre, prospective, and observational study. Sixteen CD patients, referred to the Endocrine Units of the University Hospitals of Messina, Napoli, Padova, and Palermo (Italy), successfully treated with pasireotide for 12 month have been enrolled...
January 30, 2018: Endocrine
https://www.readbyqxmd.com/read/29371000/pasireotide-in-acromegaly-by-aggressive-tumors-description-of-four-clinical-cases-towards-a-personalized-medicine
#6
Betina Biagetti, Gabriel Obiols, Elena Martinez Saez, Esteban Cordero, Jordi Mesa
No abstract text is available yet for this article.
January 19, 2018: Endocrinología, Diabetes y Nutrición
https://www.readbyqxmd.com/read/29366679/the-combination-of-an-hdac6-inhibitor-and-a-somatostatin-receptor-agonist-synergistically-reduces-hepato-renal-cystogenesis-in-an-animal-model-of-polycystic-liver-disease
#7
Maria Lorenzo Pisarello, Tatyana V Masyuk, Sergio A Gradilone, Anatoliy I Masyuk, Jingyi Francess Ding, Pui-Yuen Lee, Nicholas F LaRusso
Hepatic cystogenesis in polycystic liver disease (PLD) is associated with abnormalities in multiple cellular processes, including elevated cAMP and over-expression of histone deacetylase 6 (HDAC6). Disease progression in PCK rats (an animal model of PLD) is attenuated by inhibition of either cAMP production or HDAC6. Therefore, we hypothesized that concurrent targeting of HDAC6 and cAMP would synergistically reduce cyst growth. Changes in hepato-renal cystogenesis were examined in PCK rats treated with: i) a pan-HDAC inhibitor, panobinostat; ii) three specific HDAC6 inhibitors, ACY-1215, ACY-738, and ACY-241; and iii) a combination of ACY-1215 and the somatostatin receptor analog, pasireotide...
January 20, 2018: American Journal of Pathology
https://www.readbyqxmd.com/read/29361932/efficacy-of-combined-treatment-with-pasireotide-pegvisomant-and-cabergoline-in-an-acromegalic-patient-resistant-to-other-treatments-a-case-report
#8
A Ciresi, S Radellini, V Guarnotta, C Giordano
BACKGROUND: The approach to acromegalic patients with persistent acromegaly after surgery and inadequate response to first-generation somatostatin receptor ligands (SRLs) should be strictly tailored. Current options include new pituitary surgery and/or radiosurgery, or alternative medical treatment with SRLs high dose regimens, pegvisomant (PEG) as monotherapy, or combined therapy with the addition of PEG or cabergoline to SRLs. A new pharmacological approach includes pasireotide, a second-generation SRL approved for patients who do not adequately respond to surgery and/or for whom surgery is not an option...
January 24, 2018: BMC Endocrine Disorders
https://www.readbyqxmd.com/read/29357081/biochemical-efficacy-of-long-acting-lanreotide-depot-autogel-in-patients-with-acromegaly-na%C3%A3-ve-to-somatostatin-receptor-ligands-analysis-of-three-multicenter-clinical-trials
#9
Hussain Alquraini, Maria Del Pilar Schneider, Beloo Mirakhur, Ariel Barkan
PURPOSE: In clinical research involving acromegalic patients naïve to somatostatin-receptor ligands (SRLs), 19 and 31% of those receiving the SRLs octreotide LAR and pasireotide LAR, respectively, achieved GH < 2.5 ng/mL + normalized IGF-1 concentrations. The proportions achieving control appeared higher in the post-surgery compared with the de-novo setting with pasireotide, but more similar with octreotide. Using pooled data from multicenter clinical trials, we examined the biochemical efficacy of lanreotide depot/Autogel in similar settings...
January 22, 2018: Pituitary
https://www.readbyqxmd.com/read/29318424/pasireotide-does-not-improve-efficacy-of-aspiration-sclerotherapy-in-patients-with-large-hepatic-cysts-a-randomized-controlled-trial
#10
Titus F M Wijnands, Tom J G Gevers, Marten A Lantinga, René H Te Morsche, Leo J Schultze Kool, Joost P H Drenth
OBJECTIVES: We tested whether complementary use of the somatostatin analogue pasireotide would augment efficacy of aspiration sclerotherapy of hepatic cysts. METHODS: We conducted a double-blind, placebo-controlled trial in patients who underwent aspiration sclerotherapy of a large (>5 cm) symptomatic hepatic cyst. Patients were randomized to either intramuscular injections of pasireotide 60 mg long-acting release (n = 17) or placebo (sodium chloride 0.9 %, n = 17)...
January 9, 2018: European Radiology
https://www.readbyqxmd.com/read/29313180/a-prospective-longitudinal-study-of-pasireotide-in-nelson-s-syndrome
#11
Eleni Daniel, Miguel Debono, Sharon Caunt, Constantine Girio-Fragkoulakis, Stephen J Walters, Scott A Akker, Ashley B Grossman, Peter J Trainer, John Newell-Price
PURPOSE: Nelson's syndrome is a challenging condition that can develop following bilateral adrenalectomy for Cushing's disease, with high circulating ACTH levels, pigmentation and an invasive pituitary tumor. There is no established medical therapy. The aim of the study was to assess the effects of pasireotide on plasma ACTH and tumor volume in Nelson's syndrome. METHODS: Open labeled multicenter longitudinal trial in three steps: (1) a placebo-controlled acute response test; (2) 1 month pasireotide 300-600 μg s...
January 8, 2018: Pituitary
https://www.readbyqxmd.com/read/29226331/a-novel-pathway-activated-by-somatostatin-receptor-type-2-sst2-inhibition-of-pituitary-tumor-cell-migration-and-invasion-through-cytoskeleton-protein-recruitment
#12
E Peverelli, E Giardino, D Treppiedi, R Catalano, F Mangili, M Locatelli, A G Lania, M Arosio, A Spada, G Mantovani
The pharmacological therapy of GH-secreting pituitary tumors is based on somatostatin (SS) analogs that reduce GH secretion and cell proliferation by binding mainly SS receptors type 2 (SST2). Antimigratory effects of SS have been demonstrated in different cell models, but no data on pituitary tumors are available. Aims of our study were to evaluate SST2 effects on migration and invasion of human and rat tumoral somatotrophs, and to elucidate the molecular mechanism involved focusing on the role of cofilin and filamin A (FLNA)...
December 11, 2017: International Journal of Cancer. Journal International du Cancer
https://www.readbyqxmd.com/read/29205458/multi-disciplinary-management-of-refractory-insulinomas
#13
Emily Brown, Daniel Watkin, Jonathan Evans, Vincent Yip, Daniel J Cuthbertson
Insulinomas are predominantly benign (~90%), pancreatic neuroendocrine tumours characterised by hyperinsulinaemic hypoglycaemia. They usually present as a small (<2cm), well demarcated, solitary nodule that can arise in any part of the organ. Treatment of sporadic insulinomas is generally aimed at curative surgical resection with special consideration in genetic syndromes. Patients with significant hypoglycaemia can pose a difficult management challenge. In isolated cases where the patient is not medically fit for surgery or with metastatic spread, other treatment options are employed...
December 4, 2017: Clinical Endocrinology
https://www.readbyqxmd.com/read/29196939/clinical-and-functional-implication-of-the-components-of-somatostatin-system-in-gastroenteropancreatic-neuroendocrine-tumors
#14
Aura D Herrera-Martínez, Manuel D Gahete, Sergio Pedraza-Arevalo, Rafael Sánchez-Sánchez, Rosa Ortega-Salas, Raquel Serrano-Blanch, Raúl M Luque, María A Gálvez-Moreno, Justo P Castaño
PURPOSE: Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) comprise a heterogeneous group of malignancies often presenting with metastasis at diagnosis and whose clinical outcome is difficult to predict. Somatostatin (SST) analogs (SSAs) provide a valuable pharmacological tool to palliate hormonal symptoms, and control progression in some NETs. However, many patients do not respond to SSAs or develop resistance, and there are many uncertainties regarding pathophysiology of SST and its receptors (sst1-sst5) in GEP-NETs...
December 1, 2017: Endocrine
https://www.readbyqxmd.com/read/29155991/efficacy-and-safety-of-switching-to-pasireotide-in-acromegaly-patients-controlled-with-pegvisomant-and-first-generation-somatostatin-analogues-pape-study
#15
Ammar Muhammad, Aart J van der Lely, Patric J D Delhanty, Alof H G Dallenga, Iain K Haitsma, Joseph A M J L Janssen, Sebastian J C M M Neggers
Aim: To assess the efficacy and safety of pasireotide long-acting release (PAS-LAR) alone or in combination with pegvisomant by switching acromegaly patients who were well-controlled with somatostatin analogues (LA-SSAs) and pegvisomant to PAS-LAR with or without pegvisomant. Methods: 61 acromegaly patients were enrolled in a prospective open-label study. We included patients with an IGF-I ≤1.2 x Upper Limit of Normal (ULN) during treatment with LA-SSAs and pegvisomant...
November 15, 2017: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/29133263/prospective-evaluation-of-pasireotide-in-patients-undergoing-pancreaticoduodenectomy-the-washington-university-experience
#16
Ismael Dominguez-Rosado, Ryan C Fields, Cheryl A Woolsey, Gregory Williams, Timothy A Horwedel, J Bart Rose, Chet W Hammill, Maria B Doyle, William C Chapman, Steven M Strasberg, William G Hawkins, Dominic E Sanford
BACKGROUND: Pasireotide is a newer generation somatostatin analogue that led to a significant reduction in pancreatic fistula after pancreatectomy in a single-center randomized controlled trial. We sought to determine if pasireotide reduces the incidence of pancreatic fistula and other complications after pancreaticoduodenectomy at our high volume center. STUDY DESIGN: All patients undergoing pancreaticoduodenectomy between April 2011 and January 2017 were prospectively followed, and their complications were graded using the Modified Accordion Grading System (MAGS) in our institutional complications database...
February 2018: Journal of the American College of Surgeons
https://www.readbyqxmd.com/read/29074099/efficacy-and-safety-of-long-acting-pasireotide-or-everolimus-alone-or-in-combination-in-patients-with-advanced-carcinoids-of-the-lung-and-thymus-luna-an-open-label-multicentre-randomised-phase-2-trial
#17
Piero Ferolla, Maria Pia Brizzi, Tim Meyer, Wasat Mansoor, Julien Mazieres, Christine Do Cao, Hervé Léna, Alfredo Berruti, Vincenzo Damiano, Wieneke Buikhuisen, Henning Grønbæk, Catherine Lombard-Bohas, Christian Grohé, Vincenzo Minotti, Marcello Tiseo, Javier De Castro, Nicholas Reed, Gabriella Gislimberti, Neha Singh, Miona Stankovic, Kjell Öberg, Eric Baudin
BACKGROUND: There are no data from prospective studies focused exclusively on patients with advanced lung and thymic carcinoids. We aimed to assess the efficacy and safety of long-acting pasireotide and everolimus, administered alone or in combination, in patients with advanced carcinoids of the lung or thymus. METHODS: LUNA was a prospective, multicentre, randomised, open-label, phase 2 trial of adult patients (aged >18 years) with advanced (unresectable or metastatic), well differentiated carcinoid tumours of the lung or thymus, with radiological progression within 12 months before randomisation, and a WHO performance status of 0-2...
October 23, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/29067877/somatostatin-analogs-in-the-treatment-of-neuroendocrine-tumors-current-and-emerging-aspects
#18
Gherardo Mazziotti, Alessandra Mosca, Stefano Frara, Giovanni Vitale, Andrea Giustina
Neuroendocrine tumors (NETs) harbor somatostatin receptors and there is a strong rationale for using somatostatin analogs (SSAs) for treatment of NETs. Areas covered: This article discusses i) pharmacology of somatostatin and its analogs; ii) antisecretory and anti-proliferative effects of SSAs in NETs; iii) efficacy and safety of emerging therapeutic regimens with first generation SSAs administered at either high doses or in combination with antineoplastic drugs; iv) efficacy and safety of pasireotide and chimeric molecules; v) efficacy of radionuclide therapy of NETs using SSAs...
October 25, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/29055143/pasireotide-for-the-treatment-of-refractory-hypoglycemia-from-malignant-insulinoma
#19
Nicholas S Hendren, Kamaldeep Panach, Timothy J Brown, Lan Peng, Muhammad S Beg, Jonathan Weissler, Sasan Mirfakhraee
Insulinomas are rare, usually solitary benign tumors. The presence of metastases defines malignant insulinomas((1)) . Medical therapy primarily treats symptomatic hypoglycemia, alleviates symptoms, and improves the quality of life in affected individuals. While diazoxide is used as first-line therapy, the incomplete response rate and complications associated with diazoxide provide a role for somatostatin analogues in difficult-to-treat hypoglycemia. This article is protected by copyright. All rights reserved...
October 21, 2017: Clinical Endocrinology
https://www.readbyqxmd.com/read/29032486/population-pharmacokinetics-of-subcutaneous-pasireotide-in-healthy-volunteers-and-cushing-s-disease-patients
#20
Jerry Nedelman, Roland Fisch, Ke Hu, Ines Paule, Jocelyn Zhou
BACKGROUND AND OBJECTIVE: Pasireotide (SOM230, Signifor(®)) is a somatostatin analog approved in a subcutaneous formulation for the treatment of Cushing's disease. This analysis characterizes the population pharmacokinetics (PopPK) of subcutaneous pasireotide jointly in healthy volunteers (HVs) and Cushing's disease patients (CDPs), evaluating the effects of age, body size, and population on pasireotide pharmacokinetics. METHODS: The analysis dataset included five phase I studies and one each from phase II and phase III...
October 14, 2017: Clinical Pharmacokinetics
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