Sökning: onr:"swepub:oai:DiVA.org:uu-393745" > Long-Term Safety Ex...
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000 | 05138naa a2200517 4500 | |
001 | oai:DiVA.org:uu-393745 | |
003 | SwePub | |
008 | 191111s2019 | |||||||||||000 ||eng| | |
024 | 7 | a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-3937452 URI |
024 | 7 | a https://doi.org/10.1634/theoncologist.2018-02362 DOI |
040 | a (SwePub)uu | |
041 | a engb eng | |
042 | 9 SwePub | |
072 | 7 | a ref2 swepub-contenttype |
072 | 7 | a art2 swepub-publicationtype |
100 | 1 | a Anthony, Lowell B.u Univ Kentucky, Markey Canc Ctr, Lexington, KY USA4 aut |
245 | 1 0 | a Long-Term Safety Experience with Telotristat Ethyl Across Five Clinical Studies in Patients with Carcinoid Syndrome |
264 | c 2019-01-16 | |
264 | 1 | b WILEY,c 2019 |
338 | a print2 rdacarrier | |
520 | a Background Patients with neuroendocrine tumors (NETs) and carcinoid syndrome experience considerable morbidity and mortality; carcinoid syndrome may be associated with shorter survival. Carcinoid syndrome is linked to tumoral secretion of serotonin and other bioactive substances. The subsequent debilitating diarrhea and urgency to defecate pose significant health risks. In previous studies, telotristat ethyl, a tryptophan hydroxylase inhibitor, was effective and well tolerated in treating carcinoid syndrome diarrhea. We present pooled safety data from five clinical trials with telotristat ethyl in patients with carcinoid syndrome. Subjects, Materials, and Methods Adverse events reported during telotristat ethyl treatment were pooled from two phase II and three phase III clinical trials in 239 patients with carcinoid syndrome. Long-term safety of telotristat ethyl and causes of hospitalization and death were reviewed; overall survival was estimated. Results Mean (median; range) duration of exposure and follow-up was 1.3 years (1.1 years; 1 week to 5.7 years), with 309 total patient-years of exposure. Leading causes of hospitalization were gastrointestinal disorders or were related to the underlying tumor and related treatment. Survival estimates at 1, 2, and 3 years were 93%, 88%, and 77%. Nearly all deaths were due to progression or complication of the underlying disease; none were attributable to telotristat ethyl. There was one death in year 4. Conclusion Based on long-term safety data, telotristat ethyl is well tolerated and has a favorable long-term safety profile in patients with carcinoid syndrome. Implications for Practice Carcinoid syndrome can cause persistent diarrhea, even in patients treated with somatostatin analogs. Across five clinical trials in patients with carcinoid syndrome, telotristat ethyl has been well tolerated and efficacious, providing clinicians with a new approach to help control carcinoid syndrome diarrhea, in addition to somatostatin analog therapy. By reducing the stool frequency in patients with carcinoid syndrome whose diarrhea is refractory to anticholinergics, such as loperamide and atropine/diphenoxylate, and somatostatin analog dose escalation, improvement in quality of life becomes an achievable goal. | |
650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Cancer och onkologi0 (SwePub)302032 hsv//swe |
650 | 7 | a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cancer and Oncology0 (SwePub)302032 hsv//eng |
653 | a Malignant carcinoid syndrome | |
653 | a Tryptophan hydroxylase | |
653 | a Telotristat ethyl | |
653 | a Serotonin | |
653 | a Diarrhea | |
653 | a Neuroendocrine tumors | |
700 | 1 | a Kulke, Matthew H.u Boston Univ, Med Ctr, Boston, MA USA4 aut |
700 | 1 | a Caplin, Martyn E.u Royal Free Hosp, ENETS Ctr Excellence, Neuroendocrine Tumor Unit, London, England4 aut |
700 | 1 | a Bergsland, Emilyu Univ Calif San Francisco, Dept Med, San Francisco, CA USA4 aut |
700 | 1 | a Öberg, Kjell,d 1946-u Uppsala universitet,Endokrin tumörbiologi4 aut0 (Swepub:uu)kjellob |
700 | 1 | a Pavel, Marianneu Charite, Dept Hepatol & Gastroenterol, Berlin, Germany4 aut |
700 | 1 | a Hoersch, Dieteru Zentralklin Bad Berka, Ctr Neuroendocrine Tumors, Dept Gastroenterol Endocrinol, Bad Berka, Germany4 aut |
700 | 1 | a Warner, Richard R. P.u Icahn Sch Med Mt Sinai, Div Gastroenterol, New York, NY 10029 USA4 aut |
700 | 1 | a O'Dorisio, Thomas M.u Univ Iowa, Dept Internal Med Endocrinol & Metab, Iowa City, IA USA4 aut |
700 | 1 | a Dillon, Joseph S.u Univ Iowa, Dept Internal Med Endocrinol & Metab, Iowa City, IA USA4 aut |
700 | 1 | a Lapuerta, Pablou Lexicon Pharmaceut Inc, The Woodlands, TX USA4 aut |
700 | 1 | a Kassler-Taub, Kennethu Lexicon Pharmaceut Inc, The Woodlands, TX USA4 aut |
700 | 1 | a Liang, Wenjunu Lexicon Pharmaceut Inc, The Woodlands, TX USA4 aut |
710 | 2 | a Univ Kentucky, Markey Canc Ctr, Lexington, KY USAb Boston Univ, Med Ctr, Boston, MA USA4 org |
773 | 0 | t The Oncologistd : WILEYg 24:8, s. E662-E670q 24:8<E662-E670x 1083-7159x 1549-490X |
856 | 4 | u https://theoncologist.onlinelibrary.wiley.com/doi/pdfdirect/10.1634/theoncologist.2018-0236 |
856 | 4 8 | u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-393745 |
856 | 4 8 | u https://doi.org/10.1634/theoncologist.2018-0236 |
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