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Telotristat

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https://www.readbyqxmd.com/read/29724499/changes-in-weight-associated-with-telotristat-ethyl-in-the-treatment-of-carcinoid-syndrome
#1
Martin O Weickert, Gregory Kaltsas, Dieter Hörsch, Pablo Lapuerta, Marianne Pavel, Juan W Valle, Martyn E Caplin, Emily Bergsland, Pamela L Kunz, Lowell B Anthony, Enrique Grande, Kjell Öberg, Staffan Welin, Catherine Lombard-Bohas, John K Ramage, Ashwin Kittur, Qi M Yang, Matthew H Kulke
PURPOSE: In the placebo-controlled Phase III TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome) trial, the oral tryptophan hydroxylase inhibitor telotristat ethyl significantly reduced bowel movement (BM) frequency during a 12-week, double-blind treatment period in 135 patients with metastatic neuroendocrine tumors with carcinoid syndrome and ≥4 BMs per day. Patients (mean [SD] age, 63.5 [8.9] years; mean [SD] body mass index, 24.9 [4...
April 30, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29628275/peripheral-serotonin-synthesis-as-a-new-drug-target
#2
REVIEW
Susann Matthes, Michael Bader
The first step in serotonin (5-HT) biosynthesis is catalyzed by tryptophan hydroxylase (TPH). There are two independent sources of the monoamine that have distinct functions: first, the TPH1-expressing enterochromaffin cells (ECs) of the gut; second, TPH2-expressing serotonergic neurons. TPH1-deficient mice revealed that peripheral 5-HT plays important roles in platelet function and in inflammatory and fibrotic diseases of gut, pancreas, lung, and liver. Therefore, TPH inhibitors were developed which cannot pass the blood-brain barrier to specifically block peripheral 5-HT synthesis...
April 5, 2018: Trends in Pharmacological Sciences
https://www.readbyqxmd.com/read/29503551/developments-in-the-treatment-of-carcinoid-syndrome-impact-of-telotristat
#3
REVIEW
David L Chan, Simron Singh
Carcinoid syndrome occurs in 20% of patients with neuroendocrine tumors, and serotonin is usually the main causative hormonal peptide. Carcinoid syndrome, and particularly diarrhea, can significantly impact patients' quality of life. Somatostatin analogs (SSAs) are the mainstay of treatment, but are unable to ameliorate symptoms in all patients due to dose-limiting side effects and tachyphylaxis. Telotristat is a novel oral inhibitor of tryptophan hydroxylase, which is the rate-limiting enzyme in serotonin synthesis...
2018: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/29350062/telotristat-ethyl-a-novel-agent-for-the-therapy-of-carcinoid-syndrome-diarrhea
#4
Joseph S Dillon, Chandrikha Chandrasekharan
Carcinoid syndrome (CS), characterized by diarrhea and flushing, is present in 20% of patients with neuroendocrine tumors at diagnosis and becomes more frequent with progression. The diarrhea of CS is caused mainly by tumoral secretion of serotonin. It may not be fully controlled by somatostatin analogs, the currently indicated drugs for symptomatic relief. Telotristat ethyl is a novel inhibitor of tryptophan hydroxylase, the rate-limiting enzyme in serotonin biosynthesis. Administration of the drug decreases diarrhea in patients with CS...
January 19, 2018: Future Oncology
https://www.readbyqxmd.com/read/29330194/telotristat-ethyl-in-carcinoid-syndrome-safety-and-efficacy-in-the-telecast-phase-3-trial
#5
Marianne Pavel, David J Gross, Marta Benavent, Petros Perros, Raj Srirajaskanthan, Richard R P Warner, Matthew H Kulke, Lowell B Anthony, Pamela L Kunz, Dieter Hörsch, Martin O Weickert, Pablo Lapuerta, Wenjun Jiang, Kenneth Kassler-Taub, Suman Wason, Rosanna Fleming, Douglas Fleming, Rocio Garcia-Carbonero
Telotristat ethyl, a tryptophan hydroxylase inhibitor, was efficacious and well tolerated in the phase 3 TELESTAR study in patients with carcinoid syndrome (CS) experiencing ≥4 bowel movements per day (BMs/day) while on somatostatin analogs (SSAs). TELECAST, a phase 3 companion study, assessed the safety and efficacy of telotristat ethyl in patients with CS (diarrhea, flushing, abdominal pain, nausea or elevated urinary 5-hydroxyindoleacetic acid (u5-HIAA)) with <4 BMs/day on SSAs (or ≥1 symptom or ≥4 BMs/day if not on SSAs) during a 12-week double-blind treatment period followed by a 36-week open-label extension (OLE)...
March 2018: Endocrine-related Cancer
https://www.readbyqxmd.com/read/29232344/telotristat-ethyl-for-patients-with-carcinoid-syndrome-associated-with-chest-pain-and-hypertension
#6
Pashtoon Murtaza Kasi
No abstract text is available yet for this article.
January 2018: Pancreas
https://www.readbyqxmd.com/read/29175096/budgetary-impact-of-telotristat-ethyl-a-novel-treatment-for-patients-with-carcinoid-syndrome-diarrhea-a-us-health-plan-perspective
#7
Vijay N Joish, Feride Frech, Pablo Lapuerta
PURPOSE: Telotristat ethyl (TE) was recently approved for carcinoid syndrome diarrhea (CSD) in patients not adequately controlled with somatostatin analog long-acting release (SSA LAR) therapy alone. A budget impact model was developed to determine the short-term affordability of reimbursing TE in a US health plan. METHODS: A budget impact model compared health care costs when CSD is managed per current treatment patterns (SSA LAR, reference drug scenario) versus when TE is incorporated in the treatment algorithm (SSA LAR + TE, new drug scenario)...
December 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/29074312/understanding-the-patient-experience-with-carcinoid-syndrome-exit-interviews-from-a-randomized-placebo-controlled-study-of-telotristat-ethyl
#8
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...
November 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
#9
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...
December 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
#10
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...
February 2018: Journal of Medical Economics
https://www.readbyqxmd.com/read/28699933/telotristat-ethyl-xermelo-for-carcinoid-syndrome-diarrhea
#11
(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
#12
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
#13
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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