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Changes in Weight A...
Changes in Weight Associated With Telotristat Ethyl in the Treatment of Carcinoid Syndrome
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- Weickert, Martin O. (author)
- Univ Hosp Coventry, ENETS Ctr Excellence, ARDEN NET Ctr, Coventry CV2 2DX, W Midlands, England;Warwickshire Natl Hlth Serv Trust, Coventry CV2 2DX, W Midlands, England
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- Kaltsas, Gregory (author)
- Univ Hosp Coventry, ENETS Ctr Excellence, ARDEN NET Ctr, Coventry CV2 2DX, W Midlands, England;Warwickshire Natl Hlth Serv Trust, Coventry CV2 2DX, W Midlands, England
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- Hörsch, Dieter (author)
- Zent Klin Bad Berka, Bad Berka, Germany
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- Lapuerta, Pablo (author)
- Lexicon Pharmaceut Inc, The Woodlands, TX USA
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- Pavel, Marianne (author)
- Friedrich Alexander Univ Erlangen Nurnberg, Erlangen, Germany;Charite, Berlin, Germany
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- Valle, Juan W. (author)
- Univ Manchester, Christie Natl Hlth Serv Fdn Trust, Manchester, Lancs, England
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- Caplin, Martyn E. (author)
- Royal Free Hosp, European Neuroendocrine Tumor Soc Ctr Excellence, Neuroendocrine Tumour Unit, London, England
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- Bergsland, Emily (author)
- Univ Calif San Francisco, San Francisco, CA 94143 USA
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- Kunz, Pamela L. (author)
- Stanford Univ, Sch Med, Stanford, CA USA
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- Anthony, Lowell B. (author)
- Univ Kentucky, Lexington, KY USA
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- Grande, Enrique (author)
- MD Anderson Int Canc Ctr, Madrid, Spain
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- Öberg, Kjell, 1946- (author)
- Uppsala universitet,Endokrin tumörbiologi
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- Welin, Staffan (author)
- Uppsala universitet,Onkologisk endokrinologi
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- Lombard-Bohas, Catherine (author)
- Hosp Civils Lyon, Hop Edouard Herriot, Lyon, France
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- Ramage, John K. (author)
- Kings Coll Hosp London, Kings Hlth Partners European Neuroendocrine Tumor, London, England
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- Kittur, Ashwin (author)
- Lexicon Pharmaceut Inc, The Woodlands, TX USA
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- Yang, Qi M. (author)
- Lexicon Pharmaceut Inc, The Woodlands, TX USA
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- Kulke, Matthew H. (author)
- Dana Farber Canc Inst, Boston, MA 02115 USA
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(creator_code:org_t)
- ELSEVIER, 2018
- 2018
- English.
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In: Clinical Therapeutics. - : ELSEVIER. - 0149-2918 .- 1879-114X. ; 40:6, s. 952-962
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Abstract
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- Purpose: In the placebo-controlled Phase III TELE-STAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome) trial, the oral tryptophan hydroxylase inhibitor telotristat ethyl significantly reduced bowel movement (BM) frequency during a 12-week, double-blind treatment period in 135 patients with metastatic neuroendocrine tumors with carcinoid syndrome and >= 4 BMs per day. Patients (mean [SD] age, 63.5 [8.9] years; mean [SD] body mass index, 24.9 [4.9] kg/m(2)) received placebo, telotristat ethyl 250 mg, or telotristat ethyl 500 mg 3 times per day (TID) in addition to somatostatin analogue therapy. Weight loss is associated with uncontrolled carcinoid syndrome and may be associated with reduced survival.Methods: Assessment of the occurrence of weight change >= 3% at week 12 was prespecified in the statistical analysis plan.Findings: In 120 patients with weight data available, weight gain >= 3% was observed in 2 of 39 patients (5.1%) taking placebo [1.1), 7 of 41 (17.1%) taking telotristat ethyl 250 mg TID, and 13 of 40 (32.5%) taking telotristat ethyl 500 mg TID (P = 0.0017) at week 12. Weight loss >= 3% was observed in 5 of 39 patients (12.8%) taking placebo TID, 4 of 41 (9.8%) taking telotristat ethyl 250 mg TID, and 6 of 40 (15.0%) taking telotristat ethyl 500 mg TID (P = 0.77). Biochemical and metabolic parameters of serum albumin and cholesterol significantly increased (P = 0.02 and P = 0.001, respectively) in patients gaining weight and decreased in patients who lost weight, suggesting an improvement in overall nutritional status.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Keyword
- carcinoid syndrome
- carcinoid syndrome diarrhea
- malnutrition
- neuroendocrine tumor
- telotristat ethyl
- weight
Publication and Content Type
- ref (subject category)
- art (subject category)
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Weickert, Martin ...
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Kaltsas, Gregory
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Hörsch, Dieter
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Lapuerta, Pablo
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Pavel, Marianne
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Valle, Juan W.
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Caplin, Martyn E ...
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Bergsland, Emily
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Kunz, Pamela L.
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Anthony, Lowell ...
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Grande, Enrique
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Öberg, Kjell, 19 ...
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Welin, Staffan
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Lombard-Bohas, C ...
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Ramage, John K.
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Kittur, Ashwin
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Yang, Qi M.
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Kulke, Matthew H ...
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Uppsala University