Evidence map›Paper›PMID 33940581›Full record

ArticleNeuroendocrinology2022

Long-Term Treatment with Telotristat Ethyl in Patients with Carcinoid Syndrome Symptoms: Results from the TELEPATH Study.

Dieter Hörsch, Lowell Anthony, David J Gross, Juan W Valle, Staffan Welin, Marta Benavent, Martyn Caplin, Marianne Pavel, Emily Bergsland, Kjell Öberg and 5 more

Registry-linked trialOpen access · hybridAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Neuroendocrinology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02026063 (A Multicenter, Long-term Extension Study to Further Evaluate the Safety and Tolerability of Telotristat Etiprate), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.5field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02026063 phase3completednot on this map

A Multicenter, Long-term Extension Study to Further Evaluate the Safety and Tolerability of Telotristat Etiprate (LX1606)

TypeinterventionalSponsorLexicon PharmaceuticalsRan2014 to 2018Enrolled124ConditionsCarcinoid SyndromeArmsTelotristat etiprate
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 13 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Carcinoid Syndrome: Preclinical Models and Future Therapeutic Strategies.International journal of molecular sciences · 2023
    Review
  5. Sex differences in carcinoid syndrome: A gap to be closed.Reviews in endocrine & metabolic disorders · 2022
    Review
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 11 institutions in 5 countries.

Dieter HörschDepartment of Gastroenterology/Endocrinology, Center for Neuroendocrine Tumors, Zentralklinik Bad Berka, Bad Berka, Germany.
Lowell AnthonyMarkey Cancer Center, University of Kentucky, Lexington, Kentucky, USA.
David J GrossNeuroendocrine Tumor Unit, Department of Medicine, Endocrine Service, European Neuroendocrine Tumor Society Center of Excellence, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.
Juan W ValleUniversity of Manchester/The Christie NHS Foundation Trust, Manchester, United Kingdom.
Staffan WelinDepartment of Endocrine Oncology, Uppsala University Hospital, Uppsala, Sweden.
Marta BenaventMedical Oncology Department, Virgen del Rocío University Hospital/Instituto de Biomedicina de Sevilla, Seville, Spain.
Martyn CaplinDepartment of Gastroenterology & Hepatobiliary Medicine, Royal Free Hospital, Pond Street Centre for Gastroenterology, London, United Kingdom.
Marianne PavelDepartment of Gastroenterology and Hepatology, Charité-Universitätsmedizin, Berlin, Germany.
Emily BergslandHelen Diller Family Comprehensive Cancer Center, University of California at San Francisco, San Francisco, California, USA.
Kjell ÖbergDepartment of Endocrine Oncology, Uppsala University Hospital, Uppsala, Sweden.
Kenneth B Kassler-TaubLexicon Pharmaceuticals, Inc., The Woodlands, Texas, USA.
Polina BinderLexicon Pharmaceuticals, Inc., The Woodlands, Texas, USA.
Phillip BanksLexicon Pharmaceuticals, Inc., The Woodlands, Texas, USA.
Pablo LapuertaLexicon Pharmaceuticals, Inc., The Woodlands, Texas, USA.
Matthew H KulkeSection of Hematology/Oncology, Boston University and Boston Medical Center, Boston, Massachusetts, USA.
Lexicon Pharmaceuticals (United States) · USUppsala University Hospital · SEBoston University · USCharité - Universitätsmedizin Berlin · DEEuropean Neuroendocrine Tumor Society · DEInstituto de Biomedicina de Sevilla · ESThe Royal Free Hospital · GBUCSF Helen Diller Family Comprehensive Cancer Center · USUniversity of Kentucky · USUniversity of Manchester · GBZentralklinik Bad Berka · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTelotristat ethyl is indicated for use in combination with somatostatin analogs (SSAs) to treat carcinoid syndrome (CS) diarrhea uncontrolled by SSAs alone in adults, but long-term safety and efficacy data beyond 48 weeks are needed.

objectivesThe aims of the study were to evaluate the long-term safety and tolerability of telotristat ethyl and its effect on quality of life (QOL) in patients with CS.

methodsIn this phase 3, nonrandomized, multicenter, open-label, long-term extension study (TELEPATH), patients who participated in phase 2 or 3 trials of telotristat ethyl continued treatment at their present dose level (250 or 500 mg thrice daily) for 84 weeks. Safety and tolerability, the primary endpoint, were assessed by monitoring adverse events (AEs), serious AEs, AEs of special interest (AESIs; including liver-related AEs, depression, and gastrointestinal AEs), and deaths. The secondary objective was to evaluate changes in patients' QOL using validated cancer questionnaires and a subjective global assessment of CS symptoms.

resultsIn 124 patients exposed to telotristat ethyl for a mean of 102.6 ± 53.2 weeks, the type and frequency of AEs were consistent with those reported in previous trials. The occurrence of AESIs was not related to dosage or duration of therapy. Most AEs were mild to moderate in severity, and no deaths were related to telotristat ethyl. QOL scores remained stable, and the majority of patients reported adequate symptom relief throughout the study.

conclusionsSafety results of TELEPATH support the long-term use of telotristat ethyl in patients with CS diarrhea. Telotristat ethyl was well-tolerated and associated with sustained improvement in QOL scores (NCT02026063).

Indexed as

Malignant Carcinoid SyndromeQuality of LifeAdultHumansPhenylalaninePyrimidinesTreatment OutcomePhenylalaninePyrimidinestelotristat ethylCarcinoid syndromeDiarrheaQuality of lifeSafety and tolerabilityTelotristat ethyl

Identifiers

PMID33940581
PMCPMC8985007
OpenAlexW3157027441

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.