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dc.contributor.author | Inagaki, Nobuya | en |
dc.contributor.author | Sano, Hiroki | en |
dc.contributor.author | Seki, Yoshifumi | en |
dc.contributor.author | Kuroda, Shingo | en |
dc.contributor.author | Kaku, Kohei | en |
dc.contributor.alternative | 稲垣, 暢也 | ja |
dc.date.accessioned | 2016-06-24T06:24:12Z | - |
dc.date.available | 2016-06-24T06:24:12Z | - |
dc.date.issued | 2016-09 | - |
dc.identifier.issn | 2040-1124 | - |
dc.identifier.uri | http://hdl.handle.net/2433/215204 | - |
dc.description.abstract | Aims/Introduction: Trelagliptin is a novel once-weekly oral dipeptidyl peptidase-4 inhibitor for type 2 diabetes mellitus that was first approved in Japan. We evaluated long-term safety and efficacy of trelagliptin in Japanese patients with type 2 diabetes mellitus. Materials and Methods: This was a phase 3, multicenter, open-label study to evaluate long-term safety and efficacy of trelagliptin. Patients with type 2 diabetes mellitus inadequately controlled despite diet/exercise or treatment with one of the existing oral antidiabetic drugs along with diet/exercise received trelagliptin 100 mg orally once weekly for 52 weeks as monotherapy or combination therapies. The primary end-points were the safety variables, and the secondary end-points were glycosylated hemoglobin and fasting plasma glucose. Results: A total of 680 patients received the following antidiabetic therapies: trelagliptin monotherapy (n = 248), combination with a sulfonylurea (n = 158), a glinide (n = 67), an α-glucosidase inhibitor (n = 65), a biguanide (n = 70), or a thiazolidinedione (n = 72). During the study, 79.8% of the patients experienced at least one adverse event for monotherapy, 87.3% for combination with a sulfonylurea, 77.6% for a glinide, 81.5% for an α-glucosidase inhibitor, 64.3% for a biguanide, and 84.7% for a thiazolidinedione, respectively. Most of the adverse events were mild or moderate. The change in glycosylated hemoglobin from baseline at the end of the treatment period was -0.74 to -0.25% for each therapy. Conclusions: Once-weekly oral trelagliptin provides well-tolerated long-term safety and efficacy in both monotherapy and combination therapies in Japanese patients with type 2 diabetes mellitus. | en |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd | en |
dc.rights | © 2016 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd | en |
dc.rights | This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. | en |
dc.subject | Long-term safety and efficacy | en |
dc.subject | Trelagliptin | en |
dc.subject | Type 2 diabetes mellitus | en |
dc.title | Long-term safety and efficacy of a novel once-weekly oral trelagliptin as monotherapy or in combination with an existing oral antidiabetic drug in patients with type 2 diabetes mellitus: A 52-week open-label, phase 3 study | en |
dc.type | journal article | - |
dc.type.niitype | Journal Article | - |
dc.identifier.jtitle | Journal of Diabetes Investigation | en |
dc.identifier.volume | 7 | - |
dc.identifier.issue | 5 | - |
dc.identifier.spage | 718 | - |
dc.identifier.epage | 726 | - |
dc.relation.doi | 10.1111/jdi.12499 | - |
dc.textversion | publisher | - |
dc.identifier.pmid | 27181699 | - |
dcterms.accessRights | open access | - |
出現コレクション: | 学術雑誌掲載論文等 |
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