{"@context":{"@vocab":"https://cir.nii.ac.jp/schema/1.0/","rdfs":"http://www.w3.org/2000/01/rdf-schema#","dc":"http://purl.org/dc/elements/1.1/","dcterms":"http://purl.org/dc/terms/","foaf":"http://xmlns.com/foaf/0.1/","prism":"http://prismstandard.org/namespaces/basic/2.0/","cinii":"http://ci.nii.ac.jp/ns/1.0/","datacite":"https://schema.datacite.org/meta/kernel-4/","ndl":"http://ndl.go.jp/dcndl/terms/","jpcoar":"https://github.com/JPCOAR/schema/blob/master/2.0/"},"@id":"https://cir.nii.ac.jp/crid/1360579817310502016.json","@type":"Article","productIdentifier":[{"identifier":{"@type":"DOI","@value":"10.1530/erc-17-0455"}},{"identifier":{"@type":"URI","@value":"https://erc.bioscientifica.com/view/journals/erc/25/3/ERC-17-0455.xml"}},{"identifier":{"@type":"URI","@value":"https://syndication.highwire.org/content/doi/10.1530/ERC-17-0455"}}],"dc:title":[{"@value":"Telotristat ethyl in carcinoid syndrome: safety and efficacy in the TELECAST phase 3 trial"}],"description":[{"type":"abstract","notation":[{"@value":"<jats:p>Telotristat ethyl, a tryptophan hydroxylase inhibitor, was efficacious and well tolerated in the phase 3 TELESTAR study in patients with carcinoid syndrome (CS) experiencing ≥4 bowel movements per day (BMs/day) while on somatostatin analogs (SSAs). TELECAST, a phase 3 companion study, assessed the safety and efficacy of telotristat ethyl in patients with CS (diarrhea, flushing, abdominal pain, nausea or elevated urinary 5-hydroxyindoleacetic acid (u5-HIAA)) with <4 BMs/day on SSAs (or ≥1 symptom or ≥4 BMs/day if not on SSAs) during a 12-week double-blind treatment period followed by a 36-week open-label extension (OLE). The primary safety and efficacy endpoints were incidence of treatment-emergent adverse events (TEAEs) and percent change from baseline in 24-h u5-HIAA at week 12. Patients (<jats:italic>N</jats:italic> = 76) were randomly assigned (1:1:1) to receive placebo or telotristat ethyl 250 mg or 500 mg 3 times per day (tid); 67 continued receiving telotristat ethyl 500 mg tid during the OLE. Through week 12, TEAEs were generally mild to moderate in severity; 5 (placebo), 1 (telotristat ethyl 250 mg) and 3 (telotristat ethyl 500 mg) patients experienced serious events, and the rate of TEAEs in the OLE was comparable. At week 12, significant reductions in u5-HIAA from baseline were observed, with Hodges–Lehmann estimators of median treatment differences from placebo of −54.0% (95% confidence limits, −85.0%, −25.1%,<jats:italic>P</jats:italic> < 0.001) and −89.7% (95% confidence limits, −113.1%, −63.9%,<jats:italic>P</jats:italic> < 0.001) for telotristat ethyl 250 mg and 500 mg. These results support the safety and efficacy of telotristat ethyl when added to SSAs in patients with CS diarrhea (ClinicalTrials.gov identifier: Nbib2063659).</jats:p>"}]}],"creator":[{"@id":"https://cir.nii.ac.jp/crid/1380579817310502025","@type":"Researcher","foaf:name":[{"@value":"Marianne Pavel"}]},{"@id":"https://cir.nii.ac.jp/crid/1380579817310502032","@type":"Researcher","foaf:name":[{"@value":"David J Gross"}]},{"@id":"https://cir.nii.ac.jp/crid/1380579817310502018","@type":"Researcher","foaf:name":[{"@value":"Marta Benavent"}]},{"@id":"https://cir.nii.ac.jp/crid/1380579817310502019","@type":"Researcher","foaf:name":[{"@value":"Petros Perros"}]},{"@id":"https://cir.nii.ac.jp/crid/1380579817310502016","@type":"Researcher","foaf:name":[{"@value":"Raj Srirajaskanthan"}]},{"@id":"https://cir.nii.ac.jp/crid/1380579817310502020","@type":"Researcher","foaf:name":[{"@value":"Richard R P Warner"}]},{"@id":"https://cir.nii.ac.jp/crid/1380579817310502033","@type":"Researcher","foaf:name":[{"@value":"Matthew H Kulke"}]},{"@id":"https://cir.nii.ac.jp/crid/1380579817310502021","@type":"Researcher","foaf:name":[{"@value":"Lowell B Anthony"}]},{"@id":"https://cir.nii.ac.jp/crid/1380579817310502028","@type":"Researcher","foaf:name":[{"@value":"Pamela L Kunz"}]},{"@id":"https://cir.nii.ac.jp/crid/1380579817310502026","@type":"Researcher","foaf:name":[{"@value":"Dieter Hörsch"}]},{"@id":"https://cir.nii.ac.jp/crid/1380579817310502022","@type":"Researcher","foaf:name":[{"@value":"Martin O Weickert"}]},{"@id":"https://cir.nii.ac.jp/crid/1380579817310502031","@type":"Researcher","foaf:name":[{"@value":"Pablo Lapuerta"}]},{"@id":"https://cir.nii.ac.jp/crid/1380579817310502017","@type":"Researcher","foaf:name":[{"@value":"Wenjun Jiang"}]},{"@id":"https://cir.nii.ac.jp/crid/1380579817310502023","@type":"Researcher","foaf:name":[{"@value":"Kenneth Kassler-Taub"}]},{"@id":"https://cir.nii.ac.jp/crid/1380579817310502029","@type":"Researcher","foaf:name":[{"@value":"Suman Wason"}]},{"@id":"https://cir.nii.ac.jp/crid/1380579817310502024","@type":"Researcher","foaf:name":[{"@value":"Rosanna Fleming"}]},{"@id":"https://cir.nii.ac.jp/crid/1380579817310502027","@type":"Researcher","foaf:name":[{"@value":"Douglas Fleming"}]},{"@id":"https://cir.nii.ac.jp/crid/1380579817310502030","@type":"Researcher","foaf:name":[{"@value":"Rocio Garcia-Carbonero"}]}],"publication":{"publicationIdentifier":[{"@type":"PISSN","@value":"13510088"},{"@type":"EISSN","@value":"14796821"}],"prism:publicationName":[{"@value":"Endocrine-Related Cancer"}],"dc:publisher":[{"@value":"Bioscientifica"}],"prism:publicationDate":"2018-03","prism:volume":"25","prism:number":"3","prism:startingPage":"309","prism:endingPage":"322"},"reviewed":"false","dc:rights":["http://creativecommons.org/licenses/by/4.0/"],"url":[{"@id":"https://erc.bioscientifica.com/view/journals/erc/25/3/ERC-17-0455.xml"},{"@id":"https://syndication.highwire.org/content/doi/10.1530/ERC-17-0455"}],"createdAt":"2018-01-13","modifiedAt":"2024-06-30","relatedProduct":[{"@id":"https://cir.nii.ac.jp/crid/1390576811711421056","@type":"Article","relationType":["isReferencedBy"],"jpcoar:relatedTitle":[{"@language":"en","@value":"Telotristat Etiprate alleviates rheumatoid arthritis by targeting LGALS3 and affecting MAPK signaling"}]}],"dataSourceIdentifier":[{"@type":"CROSSREF","@value":"10.1530/erc-17-0455"},{"@type":"CROSSREF","@value":"10.5582/irdr.2022.01121_references_DOI_4ztqpkFVQSTmuWvWxwUnic27t5"}]}