Understanding the Patient Experience with Carcinoid Syndrome: Exit Interviews from a Randomized, Placebo-controlled Study of Telotristat Ethyl

Clinical Therapeutics
Lowell B AnthonyDana B DiBenedetti

Abstract

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. Participating sites were asked to invite (before randomization) all eligible patients to telephone interviews scheduled at the end of the double-blind treatment period. Patients and interviewers were blinded to treatment. All 35 interviewed participants reported diarrhea and/or excessive BMs at baseline. Patients reported that these symptoms negatively affected emotional, social, physical, and occupational well-being. Prespecified criteria for treatment response (achieving ≥30% reduction in BM frequency for at least 50% of the days) were met by 8 of 26 patients taking telotristat ethyl and 1 of 9 patients taking placebo. All 8 patients taking telotristat ethyl described clin...Continue Reading

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Citations

Feb 22, 2018·Reviews in Endocrine & Metabolic Disorders·Xi-Feng JinChristoph J Auernhammer
Dec 31, 2019·World Journal of Gastroenterology : WJG·Arvind DasariDaniel M Halperin
Jun 23, 2018·Drugs·Katherine A Lyseng-Williamson
Oct 28, 2019·Journal of Patient-reported Outcomes·Stacie HudgensPablo Lapuerta
Aug 27, 2019·Expert Review of Pharmacoeconomics & Outcomes Research·Arvind DasariDaniel M Halperin
Oct 21, 2019·Pharmacology & Therapeutics·Michael Bader
Sep 30, 2020·Pancreas·Jennifer R EadsUNKNOWN from the Carcinoid Syndrome Control Collaborative
Nov 3, 2020·Patient Preference and Adherence·Teresa A SimonAndres Gomez-Caminero
May 11, 2021·World Journal of Surgery·Håkan OhlssonMartin Almquist
Aug 12, 2021·PharmacoEconomics·I-Wen PanYa-Chen Tina Shih

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