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  • Anthony, LowellUniv Kentucky, Markey Canc Ctr, Lexington, KY USA. (author)

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

  • Article/chapterEnglish2017

Publisher, publication year, extent ...

  • Elsevier,2017
  • electronicrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:uu-339720
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-339720URI
  • https://doi.org/10.1016/j.clinthera.2017.09.013DOI

Supplementary language notes

  • Language:English
  • Summary in:English

Part of subdatabase

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • Purpose: Telotristat ethyl, an oral tryptophan hydroxylase inhibitor, is intended to treat carcinoid syndrome by reducing serotonin production. Telotristat ethyl was evaluated in FELESTAR, a Phase HI 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 sub study was conducted to provide insight into the patient experience in ILLESTAR and to help understand whether reductions in BM frequency (the primary end point) and other symptoms were clinically meaningful. Methods: 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. Findings: 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 clinically meaningful reductions in BM frequency and were very satisfied with the ability of the study drug to control their carcinoidsyndrome symptoms. Overall, reports of being very satisfied were observed in 12 patients taking telotristat ethyl and 0 taking placebo. Implications: Patient interviews revealed that I ELESTAR patients, at baseline, were significantly affected by their high BM frequency. Patient reports of their clinical trial experience supported the significance of the primary end point and clinical responder analysis in TELESTAR, helping identify and understand clinically meaningful change produced by telotristat ethyl. (C) 2017 The Authors. Published by Elsevier HS Journals, Inc.

Subject headings and genre

Added entries (persons, corporate bodies, meetings, titles ...)

  • Ervin, ClaireRTI Hlth Solut, Res Triangle Pk, NC USA. (author)
  • Lapuerta, PabloLexicon Pharmaceut Inc, 8800 Technol Forest Pl, The Woodlands, TX 77385 USA. (author)
  • Kulke, Matthew H.Dana Farber Canc Inst, Boston, MA 02115 USA. (author)
  • Kunz, PamelaStanford Canc Ctr, Stanford, CA USA. (author)
  • Bergsland, EmilyUCSF Helen Diller Family Comprehens Canc Ctr, San Francisco, CA USA. (author)
  • Hörsch, DieterZent Klin Bad Berka GmbH, Klin Innerre Med Gastroenterol & Endokrinol, Bad Berka, Germany. (author)
  • Metz, David C.Univ Penn, Perelman Sch Med, Philadelphia, PA 19104 USA. (author)
  • Pasieka, JaniceTom Baker Canc Clin, Calgary, AB, Canada. (author)
  • Paylakis, NickRoyal North Shore Hosp, St Leonards, NSW, Australia. (author)
  • Pavel, MarianneCharite, Berlin, Germany. (author)
  • Caplin, MartynRoyal Free Hosp, London, England. (author)
  • Öberg, Kjell,1946-Uppsala universitet,Endokrin tumörbiologi(Swepub:uu)kjellob (author)
  • Ramage, JohnHampshire Hosp NHS Trust, Basingstoke & North Hampshire Hosp, Basingstoke, Hants, England. (author)
  • Evans, EmilyRTI Hlth Solut, Res Triangle Pk, NC USA. (author)
  • Yang, Qi MelissaLexicon Pharmaceut Inc, 8800 Technol Forest Pl, The Woodlands, TX 77385 USA. (author)
  • Jackson, ShannaLexicon Pharmaceut Inc, 8800 Technol Forest Pl, The Woodlands, TX 77385 USA. (author)
  • Arnold, KatieLexicon Pharmaceut Inc, 8800 Technol Forest Pl, The Woodlands, TX 77385 USA. (author)
  • Law, LindaLexicon Pharmaceut Inc, 8800 Technol Forest Pl, The Woodlands, TX 77385 USA.;BioHealthConsult, 2143 Riverside Dr, Cincinnati, OH 45202 USA. (author)
  • DiBenedetti, Dana B.RTI Hlth Solut, Res Triangle Pk, NC USA. (author)
  • Univ Kentucky, Markey Canc Ctr, Lexington, KY USA.RTI Hlth Solut, Res Triangle Pk, NC USA. (creator_code:org_t)

Related titles

  • In:Clinical Therapeutics: Elsevier39:11, s. 2158-21680149-29181879-114X

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