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dc.contributor.authorHorsch, D.
dc.contributor.authorAnthony, L.
dc.contributor.authorGross, D. J.
dc.contributor.authorValle, Juan W
dc.contributor.authorWelin, S.
dc.contributor.authorBenavent, M.
dc.contributor.authorCaplin, M.
dc.contributor.authorPavel, M.
dc.contributor.authorBergsland, E.
dc.contributor.authorOberg, K.
dc.contributor.authorKassler-Taub, K. B.
dc.contributor.authorBinder, P.
dc.contributor.authorBanks, P.
dc.contributor.authorLapuerta, P.
dc.contributor.authorKulke, M. H.
dc.date.accessioned2021-10-28T09:26:19Z
dc.date.available2021-10-28T09:26:19Z
dc.date.issued2021en
dc.identifier.citationH�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.en
dc.identifier.pmid33940581en
dc.identifier.doi10.1159/000516958en
dc.identifier.urihttp://hdl.handle.net/10541/624734
dc.description.abstractIntroduction: 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 scoresen
dc.language.isoenen
dc.relation.urlhttps://dx.doi.org/10.1159/000516958en
dc.titleLong-term treatment with telotristat ethyl in patients with carcinoid syndrome symptoms: results from the TELEPATH studyen
dc.typeArticleen
dc.contributor.departmentDepartment of Gastroenterology/Endocrinology, Center for Neuroendocrine Tumors, Zentralklinik Bad Berka, Bad Berka, Germanyen
dc.identifier.journalNeuroendocrinologyen
dc.description.noteen]
refterms.dateFOA2021-11-03T09:22:32Z


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