Weight Maintenance up to 48 Weeks in Patients With Carcinoid Syndrome Treated With Telotristat Ethyl: Pooled Data From the Open-Label Extensions of the Phase III Clinical Trials TELESTAR and TELECAST.

Abstract	Reported incidences of neuroendocrine tumors (NETs) appear to be increasing, possibly due to greater disease awareness and increased accuracy of diagnosis. Approximately 20% of patients with NETs develop carcinoid syndrome (CS), which arises from elevated secretion of bioactive compounds, including serotonin, from NETs. This leads to symptoms including diarrhea and flushing, which result in weight loss and are associated with considerable negative impact on patients' quality of life. We previously reported significant weight gain and improved nutritional status in patients with NETs who were treated with telotristat ethyl (TE) for 12 weeks. In this follow-up analysis, using pooled data from the 36-week open-label extensions of the TELESTAR (NCT01677910) and TELECAST (NCT02063659) phase III trials, we demonstrate that improvements in weight and nutritional parameters were sustained or further improved in patients with CS through to week 48 of treatment with TE. At week 48/end of study, 68.7% of all patients maintained a stable weight or had weight gain and the mean changes from baseline in cholesterol and albumin levels in patients treated with TE were +0.41 mmol/L and -0.34 g/L, respectively. These results indicate that TE, alongside routine clinical practice, may provide long-term benefits in nutritional intake and weight evolution in patients with CS.
Authors	Rajaventhan Srirajaskanthan, Marianne Pavel, Matthew Kulke, Dominique Clement, Aude Houchard, Lucie Keeber, Martin O Weickert
Journal	Clinical therapeutics (Clin Ther) Vol. 43 Issue 10 Pg. 1779-1785 (10 2021) ISSN: 1879-114X [Electronic] United States
PMID	34598813 (Publication Type: Clinical Trial, Phase III, Journal Article, Research Support, Non-U.S. Gov't)
Copyright	Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.
Chemical References	Pyrimidines Phenylalanine telotristat ethyl
Topics	Body Weight Maintenance Humans Malignant Carcinoid Syndrome (drug therapy) Phenylalanine (analogs & derivatives) Pyrimidines Quality of Life Treatment Outcome Weight Loss

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