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Sökning: WFRF:(Arthur H) > (2015-2019) > Telotristat Ethyl, ...

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FältnamnIndikatorerMetadata
00004804naa a2200493 4500
001oai:DiVA.org:uu-315064
003SwePub
008170301s2017 | |||||||||||000 ||eng|
024a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-3150642 URI
024a https://doi.org/10.1200/JCO.2016.69.27802 DOI
040 a (SwePub)uu
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
100a Kulke, Matthew H.u Dana Farber Canc Inst, Boston, MA 02115 USA.4 aut
2451 0a Telotristat Ethyl, a Tryptophan Hydroxylase Inhibitor for the Treatment of Carcinoid Syndrome
264 1c 2017
338 a print2 rdacarrier
520 a Purpose Preliminary studies suggested that telotristat ethyl, a tryptophan hydroxylase inhibitor, reduces bowel movement (BM) frequency in patients with carcinoid syndrome. This placebo-controlled phase III study evaluated telotristat ethyl in this setting. Patients and Methods Patients (N = 135) experiencing four or more BMs per day despite stable-dose somatostatin analog therapy received (1: 1: 1) placebo, telotristat ethyl 250 mg, or telotristat ethyl 500 mg three times per day orally during a 12-week double-blind treatment period. The primary end point was change from baseline in BM frequency. In an open-label extension, 115 patients subsequently received telotristat ethyl 500 mg. Results Estimated differences in BM frequency per day versus placebo averaged over 12 weeks were -0.81 for telotristat ethyl 250 mg (P < .001) and -0.69 for telotristat ethyl 500 mg (P,.001). At week 12, mean BM frequency reductions per day for placebo, telotristat ethyl 250 mg, and telotristat ethyl 500 mg were -0.9, -1.7, and -2.1, respectively. Responses, predefined as a BM frequency reduction >= 30% from baseline for >= 50% of the double-blind treatment period, were observed in 20%, 44%, and 42% of patients given placebo, telotristat ethyl 250 mg, and telotristat ethyl 500 mg, respectively. Both telotristat ethyl dosages significantly reduced mean urinary 5-hydroxyindole acetic acid versus placebo at week 12 (P < .001). Mild nausea and asymptomatic increases in gamma-glutamyl transferase were observed in some patients receiving telotristat ethyl. Follow-up of patients during the open-label extension revealed no new safety signals and suggested sustained BM responses to treatment. Conclusion Among patients with carcinoid syndrome not adequately controlled by somatostatin analogs, treatment with telotristat ethyl was generally safe and well tolerated and resulted in significant reductions in BM frequency and urinary 5-hydroxyindole acetic acid.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Cancer och onkologi0 (SwePub)302032 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cancer and Oncology0 (SwePub)302032 hsv//eng
700a Hoersch, Dieteru Zentralklinik Bad Berka, Bad Berka, Germany.4 aut
700a Caplin, Martyn E.u Royal Free Hosp, London, England.4 aut
700a Anthony, Lowell B.u Univ Kentucky, Lexington, KY USA.4 aut
700a Bergsland, Emilyu Univ Calif San Francisco, Helen Diller Family Comprehens Canc Ctr, San Francisco, CA 94143 USA.4 aut
700a Öberg, Kjellu Uppsala universitet,Endokrin tumörbiologi4 aut0 (Swepub:uu)kjellob
700a Welin, Staffanu Uppsala universitet,Institutionen för medicinska vetenskaper4 aut0 (Swepub:uu)stafweli
700a Warner, Richard R. P.u Icahn Sch Med Mt Sinai, New York, NY 10029 USA.4 aut
700a Lombard-Bohas, Catherineu Hosp Civils Lyon, Hop Edouard Herriot, Lyon, France.4 aut
700a Kunz, Pamela L.u Stanford Univ, Palo Alto, CA 94304 USA.4 aut
700a Grande, Enriqueu Hosp Univ Ramon y Cajal, Madrid, Spain.4 aut
700a Valle, Juan W.u Univ Manchester, Christie Natl Hlth Serv Fdn Trust, Manchester, Lancs, England.4 aut
700a Fleming, Douglasu Ipsen Biosci, Cambridge, MA USA.4 aut
700a Lapuerta, Pablou Lexicon Pharmaceut, The Woodlands, TX USA.4 aut
700a Banks, Phillipu Lexicon Pharmaceut, The Woodlands, TX USA.4 aut
700a Jackson, Shannau Lexicon Pharmaceut, The Woodlands, TX USA.4 aut
700a Zambrowicz, Brianu Lexicon Pharmaceut, The Woodlands, TX USA.4 aut
700a Sands, Arthur T.u Lexicon Pharmaceut, The Woodlands, TX USA.4 aut
700a Pavel, Marianneu Charite, Berlin, Germany.4 aut
710a Dana Farber Canc Inst, Boston, MA 02115 USA.b Zentralklinik Bad Berka, Bad Berka, Germany.4 org
773t Journal of Clinical Oncologyg 35:1, s. 14-23q 35:1<14-23x 0732-183Xx 1527-7755
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-315064
8564 8u https://doi.org/10.1200/JCO.2016.69.2780

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