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    Long-term treatment with telotristat ethyl in patients with carcinoid syndrome symptoms: results from the TELEPATH study

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    Authors
    Horsch, D.
    Anthony, L.
    Gross, D. J.
    Valle, Juan W
    Welin, S.
    Benavent, M.
    Caplin, M.
    Pavel, M.
    Bergsland, E.
    Oberg, K.
    Kassler-Taub, K. B.
    Binder, P.
    Banks, P.
    Lapuerta, P.
    Kulke, M. H.
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    Affiliation
    Department of Gastroenterology/Endocrinology, Center for Neuroendocrine Tumors, Zentralklinik Bad Berka, Bad Berka, Germany
    Issue Date
    2021
    
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    Abstract
    Introduction: Telotristat 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. Objectives: The 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. Methods: In 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. Results: In 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. Conclusions: Safety 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
    Citation
    H�rsch D, Anthony L, Gross DJ, Valle J, Welin S, Benavent M, et al. Long-term Treatment with Telotristat Ethyl in Patients with Carcinoid Syndrome Symptoms: Results from the TELEPATH Study. Neuroendocrinology. S. Karger AG; 2021.
    Journal
    Neuroendocrinology
    URI
    http://hdl.handle.net/10541/624734
    DOI
    10.1159/000516958
    PubMed ID
    33940581
    Additional Links
    https://dx.doi.org/10.1159/000516958
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1159/000516958
    Scopus Count
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