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Telotristat

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https://www.readbyqxmd.com/read/29074312/understanding-the-patient-experience-with-carcinoid-syndrome-exit-interviews-from-a-randomized-placebo-controlled-study-of-telotristat-ethyl
#1
Lowell Anthony, Claire Ervin, Pablo Lapuerta, Matthew H Kulke, Pamela Kunz, Emily Bergsland, Dieter Hörsch, David C Metz, Janice Pasieka, Nick Pavlakis, Marianne Pavel, Martyn Caplin, Kjell Öberg, John Ramage, Emily Evans, Qi Melissa Yang, Shanna Jackson, Karie Arnold, Linda Law, Dana B DiBenedetti
PURPOSE: Telotristat ethyl, an oral tryptophan hydroxylase inhibitor, is intended to treat carcinoid syndrome by reducing serotonin production. Telotristat ethyl was evaluated in TELESTAR, a Phase III study for patients who had carcinoid syndrome with at least 4 bowel movements (BMs) per day and who were receiving somatostatin analogue therapy. This interview substudy was conducted to provide insight into the patient experience in TELESTAR and to help understand whether reductions in BM frequency (the primary end point) and other symptoms were clinically meaningful...
October 23, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/29051994/telotristat-ethyl-proof-of-principle-and-the-first-oral-agent-in-the-management-of-well-differentiated-metastatic-neuroendocrine-tumor-and-carcinoid-syndrome-diarrhea
#2
REVIEW
Muhammad Masab, Muhammad Wasif Saif
INTRODUCTION: Metastatic neuroendocrine tumors (NETs) are associated with carcinoid syndrome that is typically characterized by diarrhea, cutaneous flushing and bronchospasm. Treatment with somatostatin analogues (SSA) improves the symptom burden but a significant proportion of patients stop responding to SSA therapy eventually. Novel agents with the potential to effectively control the symptoms are urgently needed. METHODS: This article reviews an in-depth analysis of the phase I-III clinical trials determining the clinical rationale for the use of tryptophan hydroxylase inhibitor, telotristat ethyl in patients with well-differentiated metastatic NETs and uncontrolled carcinoid syndrome...
October 19, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28959913/cost-effectiveness-analysis-of-telotristat-ethyl-for-treatment-of-carcinoid-syndrome-diarrhea-inadequately-controlled-with-somatostatin-analogs
#3
V N Joish, F Frech, P Lapuerta
AIMS: This study evaluated the cost-effectiveness of telotristat ethyl (TE) added to somatostatin analog octreotide (SSA + TE) compared to octreotide alone (SSA) in patients with carcinoid syndrome diarrhea (CSD) whose symptoms remain uncontrolled with SSA alone. MATERIALS AND METHODS: A deterministic Markov model evaluated the costs and quality-adjusted life-years (QALY) gained with SSA + TE vs SSA per a third-party US payer perspective. The model reflected clinical practice and resource use estimates based on current standards of care, with utility estimates based on similar symptoms from ulcerative colitis...
October 9, 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/28699933/telotristat-ethyl-xermelo-for-carcinoid-syndrome-diarrhea
#4
(no author information available yet)
No abstract text is available yet for this article.
July 17, 2017: Medical Letter on Drugs and Therapeutics
https://www.readbyqxmd.com/read/28609356/the-north-american-neuroendocrine-tumor-society-consensus-guidelines-for-surveillance-and-medical-management-of-midgut-neuroendocrine-tumors
#5
Jonathan R Strosberg, Thorvardur R Halfdanarson, Andrew M Bellizzi, Jennifer A Chan, Joseph S Dillon, Anthony P Heaney, Pamela L Kunz, Thomas M O'Dorisio, Riad Salem, Eva Segelov, James R Howe, Rodney F Pommier, Kari Brendtro, Mohammad A Bashir, Simron Singh, Michael C Soulen, Laura Tang, Jerome S Zacks, James C Yao, Emily K Bergsland
There have been significant developments in diagnostic and therapeutic options for patients with neuroendocrine tumors (NETs). Key phase 3 studies include the CLARINET trial, which evaluated lanreotide in patients with nonfunctioning enteropancreatic NETs; the RADIANT-2 and RADIANT-4 studies, which evaluated everolimus in functioning and nonfunctioning NETs of the gastrointestinal tract and lungs; the TELESTAR study, which evaluated telotristat ethyl in patients with refractory carcinoid syndrome; and the NETTER-1 trial, which evaluated Lu-DOTATATE in NETs of the small intestine and proximal colon (midgut)...
July 2017: Pancreas
https://www.readbyqxmd.com/read/28507564/management-of-the-hormonal-syndrome-of-neuroendocrine-tumors
#6
Paweł Gut, Joanna Waligórska-Stachura, Agata Czarnywojtek, Nadia Sawicka-Gutaj, Maciej Bączyk, Katarzyna Ziemnicka, Jakub Fischbach, Kosma Woliński, Jarosław Kaznowski, Elżbieta Wrotkowska, Marek Ruchała
Gastroenteropancreatic neuroendocrine tumors (GEP/NET) are unusual and rare neoplasms that present many clinical challenges. They characteristically synthesize store and secrete a variety of peptides and neuroamines which can lead to the development of distinct clinical syndrome, however many are clinically silent until late presentation with mass effects. Management strategies include surgery cure and cytoreduction with the use of somatostatin analogues. Somatostatin have a broad range of biological actions that include inhibition of exocrine and endocrine secretions, gut motility, cell proliferation, cell survival and angiogenesis...
April 1, 2017: Archives of Medical Science: AMS
https://www.readbyqxmd.com/read/28479837/pharmaceutical-approval-update
#7
Mary Choy
Brodalumab (Siliq) for moderate-to-severe plaque psoriasis in adults; telotristat ethyl (Xermelo) for carcinoid syndrome diarrhea in combination with somatostatin analogue therapy in adults; and desmopressin acetate (Noctiva) for adults with nocturnal polyuria.
May 2017: P & T: a Peer-reviewed Journal for Formulary Management
https://www.readbyqxmd.com/read/28382568/telotristat-ethyl-first-global-approval
#8
Anthony Markham
Telotristat ethyl (Xermelo™) is a peripheral tryptophan hydroxylase (TPH) inhibitor that was developed by Lexicon Pharmaceuticals, Inc. for the treatment of carcinoid syndrome. Many neuroendocrine tumours secrete serotonin (5-HT) into the blood stream, resulting in a number of symptoms, notably diarrhoea. Telotristat ethyl inhibits TPH, thereby reducing the production of 5-HT. In February 2017, telotristat ethyl was approved in the USA for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy...
May 2017: Drugs
https://www.readbyqxmd.com/read/28286921/treatment-strategies-for-metastatic-neuroendocrine-tumors-of-the-gastrointestinal-tract
#9
REVIEW
Mauro Cives, Jonathan Strosberg
The therapeutic landscape of gastroenteropancreatic-neuroendocrine tumors (GEP-NETs) has evolved significantly in recent years. Current and emerging treatment options include somatostatin analogs, radiolabeled somatostatin analogs, the mTOR inhibitor everolimus, and the tyrosine kinase inhibitor sunitinib. Although high-quality data from phase III trials are lacking, cytotoxic agents are commonly used for the treatment of poorly differentiated neuroendocrine carcinomas and well-differentiated NETs originating in the pancreas...
March 2017: Current Treatment Options in Oncology
https://www.readbyqxmd.com/read/27928191/defibrotide
#10
Danial E Baker, Kendra Demaris
Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are are available online to subscribers...
November 2016: Hospital Pharmacy
https://www.readbyqxmd.com/read/27918724/telotristat-ethyl-a-tryptophan-hydroxylase-inhibitor-for-the-treatment-of-carcinoid-syndrome
#11
RANDOMIZED CONTROLLED TRIAL
Matthew H Kulke, Dieter Hörsch, Martyn E Caplin, Lowell B Anthony, Emily Bergsland, Kjell Öberg, Staffan Welin, Richard R P Warner, Catherine Lombard-Bohas, Pamela L Kunz, Enrique Grande, Juan W Valle, Douglas Fleming, Pablo Lapuerta, Phillip Banks, Shanna Jackson, Brian Zambrowicz, Arthur T Sands, Marianne Pavel
Purpose Preliminary studies suggested that telotristat ethyl, a tryptophan hydroxylase inhibitor, reduces bowel movement (BM) frequency in patients with carcinoid syndrome. This placebo-controlled phase III study evaluated telotristat ethyl in this setting. Patients and Methods Patients (N = 135) experiencing four or more BMs per day despite stable-dose somatostatin analog therapy received (1:1:1) placebo, telotristat ethyl 250 mg, or telotristat ethyl 500 mg three times per day orally during a 12-week double-blind treatment period...
January 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/27817224/telotristat-ethyl-a-new-option-for-the-management-of-carcinoid-syndrome
#12
REVIEW
Angela Lamarca, Jorge Barriuso, Mairéad G McNamara, Richard A Hubner, Juan W Valle
Many patients with neuroendocrine tumour-related carcinoid syndrome treated with somatostatin analogues (SSA) won't achieve adequate symptom relief with the SSA alone; new treatment options are required. Telotristat ethyl is a tryptophan hydroxylase inhibitor, developed for the treatment of carcinoid syndrome. Areas covered: This review summarises the evidence supporting the role of telotristat ethyl in the management of carcinoid syndrome. Rationale, pharmacodynamics, pharmacokinetics, metabolism, clinical experience, efficacy and toxicity profiles are covered...
December 2016: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/27635672/treatment-of-symptomatic-neuroendocrine-tumor-syndromes-recent-advances-and-controversies
#13
REVIEW
Tetsuhide Ito, Lingaku Lee, Robert T Jensen
Neuroendocrine tumors(NETs), once thought rare, are increasing in frequency in most countries and receiving increasing-attention. NETs present two-treatment problems. A proportion is aggressive and a proportion has a functional, hormone-excess-state(F-NET), each of which must be treated. Recently, there have been many advances, well-covered in reviews/consensus papers on imaging-NETs; new, novel anti-tumor treatments and understanding their pathogenesis. However, little attention has been paid to advances in the treatment of the hormone-excess-state...
November 2016: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/27444653/serotonin-biosynthesis-as-a-predictive-marker-of-serotonin-pharmacodynamics-and-disease-induced-dysregulation
#14
Richard W D Welford, Magali Vercauteren, Annette Trébaul, Christophe Cattaneo, Doriane Eckert, Marco Garzotti, Patrick Sieber, Jérôme Segrestaa, Rolf Studer, Peter M A Groenen, Oliver Nayler
The biogenic amine serotonin (5-HT) is a multi-faceted hormone that is synthesized from dietary tryptophan with the rate limiting step being catalyzed by the enzyme tryptophan hydroxylase (TPH). The therapeutic potential of peripheral 5-HT synthesis inhibitors has been demonstrated in a number of clinical and pre-clinical studies in diseases including carcinoid syndrome, lung fibrosis, ulcerative colitis and obesity. Due to the long half-life of 5-HT in blood and lung, changes in steady-state levels are slow to manifest themselves...
2016: Scientific Reports
https://www.readbyqxmd.com/read/27236421/diagnosis-and-management-of-gastrointestinal-neuroendocrine-tumors-an-evidence-based-canadian-consensus
#15
REVIEW
Simron Singh, Sylvia L Asa, Chris Dey, Hagen Kennecke, David Laidley, Calvin Law, Timothy Asmis, David Chan, Shereen Ezzat, Rachel Goodwin, Ozgur Mete, Janice Pasieka, Juan Rivera, Ralph Wong, Eva Segelov, Daniel Rayson
The majority of neuroendocrine tumors originate in the digestive system and incidence is increasing within Canada and globally. Due to rapidly evolving evidence related to diagnosis and clinical management, updated guidance on the diagnosis and treatment of gastrointestinal neuroendocrine tumors (GI-NETs) are of clinical importance. Well-differentiated GI-NETs may exhibit indolent clinical behavior and are often metastatic at diagnosis. Some NET patients will develop secretory disease requiring symptom control to optimize quality of life and clinical outcomes...
June 2016: Cancer Treatment Reviews
https://www.readbyqxmd.com/read/27138571/will-clinical-heterogeneity-of-neuroendocrine-tumors-impact-their-management-in-the-future-lessons-from-recent-trials
#16
REVIEW
Mauro Cives, Heloisa P Soares, Jonathan Strosberg
PURPOSE OF REVIEW: Neuroendocrine tumors (NETs) are a group of biologically and clinically heterogeneous neoplasms arising from the diffuse neuroendocrine system. In the last few years, advances in our understanding of the biology of these tumors have translated into an expansion of treatment options for patients with NETs. Current treatment modalities include somatostatin analogs (SSAs), radiolabeled SSAs, targeted agents, cytotoxic drugs and liver-directed therapies for the management of metastatic disease...
July 2016: Current Opinion in Oncology
https://www.readbyqxmd.com/read/27107003/inhibition-of-peripheral-synthesis-of-serotonin-as-a-new-target-in-neuroendocrine-tumors
#17
REVIEW
Javier Molina-Cerrillo, Teresa Alonso-Gordoa, Olga Martínez-Sáez, Enrique Grande
UNLABELLED: : The carcinoid syndrome represents a set of signs and symptoms associated with neuroendocrine tumors (NETs) that occur primarily when metastases are developed in the liver, resulting in the worsening of quality of life. Serotonin plays a central role in the physiology of carcinoid syndrome by promoting intestinal motility. Somatostatin analogs (SSAs) have widely demonstrated their efficacy as symptomatic relievers of carcinoid syndrome, but this control is ephemeral, being reduced by approximately 50% within the first year...
June 2016: Oncologist
https://www.readbyqxmd.com/read/27041406/patient-reported-symptom-experiences-in-patients-with-carcinoid-syndrome-after-participation-in-a-study-of-telotristat-etiprate-a-qualitative-interview-approach
#18
RANDOMIZED CONTROLLED TRIAL
Heather L Gelhorn, Matthew H Kulke, Thomas O'Dorisio, Qi M Yang, Jessica Jackson, Shanna Jackson, Kristi A Boehm, Linda Law, Jacqueline Kostelec, Priscilla Auguste, Pablo Lapuerta
PURPOSE: Telotristat etiprate, a tryptophan hydroxylase inhibitor, was previously evaluated in a Phase II randomized, placebo-controlled clinical trial in patients with carcinoid syndrome (CS) and diarrhea not adequately controlled by octreotide. The objective of the current study was to characterize the symptom experiences of patients participating in that trial. METHODS: Consenting patients participated in one-on-one, qualitative interviews focused on eliciting symptoms they had experienced in association with their CS diagnosis and recollection of symptom changes they experienced while participating in the Phase II trial...
2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/26303703/clinical-syndromes-related-to-gastrointestinal-neuroendocrine-neoplasms
#19
REVIEW
Georgios Boutzios, Gregory Kaltsas
Neuroendocrine neoplasms (NENs) comprise a heterogeneous group of tumors derived from multipotent neuroendocrine cells that have the inherent ability to synthesize and secrete a variety of substances (peptides and amines). When these substances are bioactive, NENs can present with a related clinical syndrome (functioning NENs) and/or symptoms of mass effects (functioning and nonfunctioning NENs). NENs differ in their pathogenesis, clinical syndromes produced, aspects of biological behavior and response to certain antitumor treatment...
2015: Frontiers of Hormone Research
https://www.readbyqxmd.com/read/26206858/blocking-peripheral-serotonin-synthesis-by-telotristat-etiprate-lx1032-lx1606-reduces-severity-of-both-chemical-and-infection-induced-intestinal-inflammation
#20
Janice J Kim, Huaqing Wang, Joshua D Terc, Brian Zambrowicz, Qi M Yang, Waliul I Khan
Mucosal inflammation is accompanied by an alteration in 5-HT. Intestinal 5-HT synthesis is catalyzed by tryptophan hydroxylase 1 (Tph1) and we have shown that mice deficient in this rate-limiting enzyme have reduced severity of intestinal inflammation in models of chemical-induced experimental colitis. Here, we investigated the effect of blocking peripheral 5-HT synthesis in generation of intestinal inflammation by a using peripheral Tph inhibitor, telotristat etiprate (LX1606), in models of intestinal inflammation...
September 15, 2015: American Journal of Physiology. Gastrointestinal and Liver Physiology
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