| ○種別 (必須): | □ | 学術論文 (審査論文)
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| ○言語 (必須): | □ | 英語
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| ○審査 (推奨): |
| ○カテゴリ (推奨): |
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| ○学究種別 (推奨): |
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| ○著者 (必須): | 1. | (英) Oyama J (日) (読)
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| 2. | (英) Murohara T (日) (読)
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| 3. | (英) Kitakaze M (日) (読)
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| 4. | (英) Ishizu T (日) (読)
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| 5. | (英) Sato Y (日) (読)
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| 6. | (英) Kitagawa K (日) (読)
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| 7. | (英) Kamiya H (日) (読)
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| 8. | (英) Ajioka M (日) (読)
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| 9. | (英) Ishiara M (日) (読)
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| 10. | (英) Dai K (日) (読)
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| 11. | (英) Nanasato M (日) (読)
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| 12. | 佐田 政隆 ([徳島大学.大学院医歯薬学研究部.医学域.医科学部門.内科系.循環器内科学])
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| 13. | (英) Maemura K (日) (読)
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| 14. | (英) Tomiyama H (日) (読)
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| 15. | (英) Higashi Y (日) (読)
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| 16. | (英) Kaku K (日) (読)
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| 17. | 山田 博胤 ([徳島大学.大学院医歯薬学研究部.医学域.連携研究部門(医学域).寄附講座系(医学域).地域循環器内科学])
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| 18. | 松久 宗英
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| 19. | (英) Yamashita K (日) (読)
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| 20. | (英) Bando YK (日) (読)
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| 21. | (英) Kashihara N (日) (読)
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| 22. | (英) Ueda S (日) (読)
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| 23. | (英) Inoue T (日) (読)
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| 24. | (英) Node K (日) (読)
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| 25. | (英) PROLOGUE Study Investigators (日) (読)
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| ○題名 (必須): | □ | (英) The Effect of Sitagliptin on Carotid Artery Atherosclerosis in Type 2 Diabetes: The PROLOGUE Randomized Controlled Trial. (日)
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| ○副題 (任意): |
| ○要約 (任意): | □ | (英) BACKGROUND: Experimental studies have suggested that dipeptidyl peptidase-4 (DPP-4) inhibitors provide cardiovascular protective effects. We performed a randomized study to evaluate the effects of sitagliptin added on to the conventional therapy compared with conventional therapy alone (diet, exercise, and/or drugs, except for incretin-related agents) on the intima-media thickness (IMT) of the carotid artery, a surrogate marker for the evaluation of atherosclerotic cardiovascular disease, in people with type 2 diabetes mellitus (T2DM).METHODS AND FINDINGS: We used a multicenter PROBE (prospective, randomized, open label, blinded endpoint) design. Individuals aged 30 y with T2DM (6.2% HbA1c < 9.4%) were randomly allocated to receive either sitagliptin (25 to 100 mg/d) or conventional therapy. Carotid ultrasound was performed at participating medical centers, and all parameters were measured in a core laboratory. Of the 463 enrolled participants with T2DM, 442 were included in the primary analysis (sitagliptin group, 222; conventional therapy group, 220). Estimated mean (± standard error) common carotid artery IMT at 24 mo of follow-up in the sitagliptin and conventional therapy groups was 0.827 ± 0.007 mm and 0.837 ± 0.007 mm, respectively, with a mean difference of -0.009 mm (97.2% CI -0.028 to 0.011, p = 0.309). HbA1c level at 24 mo was significantly lower with sitagliptin than with conventional therapy (6.56% ± 0.05% versus 6.72% ± 0.05%, p = 0.008; group mean difference -0.159, 95% CI -0.278 to -0.041). Episodes of serious hypoglycemia were recorded only in the conventional therapy group, and the rate of other adverse events was not different between the two groups. As it was not a placebo-controlled trial and carotid IMT was measured as a surrogate marker of atherosclerosis, there were some limitations of interpretation.CONCLUSIONS: In the PROLOGUE study, there was no evidence that treatment with sitagliptin had an additional effect on the progression of carotid IMT in participants with T2DM beyond that achieved with conventional treatment.TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry UMIN000004490. (日)
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| ○発行所 (推奨): | □ | (英) Public Library of Science (日) (読)
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| ○誌名 (必須): | □ | PLoS Medicine (Public Library of Science)
(pISSN: 1549-1277, eISSN: 1549-1676)
| ○ISSN (任意): | □ | 1549-1676
ISSN: 1549-1277
(pISSN: 1549-1277, eISSN: 1549-1676) Title: PLoS medicineTitle(ISO): PLoS MedPublisher: PLOS (NLM Catalog)
(Scopus)
(CrossRef)
(Scopus information is found. [need login]) | [継承] |
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| ○巻 (必須): | □ | 13
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| ○号 (必須): | □ | 6
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| ○頁 (必須): | □ | e1002051 e1002051
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| ○都市 (任意): |
| ○年月日 (必須): | □ | 西暦 2016年 6月 28日 (平成 28年 6月 28日)
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| ○URL (任意): |
| ○DOI (任意): | □ | 10.1371/journal.pmed.1002051 (→Scopusで検索)
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| ○PMID (任意): | □ | 27351380 (→Scopusで検索)
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| ○備考 (任意): | 1. | (英) Article.ELocationID: 10.1371/journal.pmed.1002051 (日)
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| 2. | (英) Article.PublicationTypeList.PublicationType: Journal Article (日)
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| 3. | (英) OtherID: PMC4924847 (日)
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