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j.parkreldis.2018.08.024.pdf | 537.8 kB | Adobe PDF | 見る/開く |
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dc.contributor.author | Hattori, Nobutaka | en |
dc.contributor.author | Takeda, Atsushi | en |
dc.contributor.author | Takeda, Shinichi | en |
dc.contributor.author | Nishimura, Akira | en |
dc.contributor.author | Kitagawa, Tadayuki | en |
dc.contributor.author | Mochizuki, Hideki | en |
dc.contributor.author | Nagai, Masahiro | en |
dc.contributor.author | Takahashi, Ryosuke | en |
dc.contributor.alternative | 服部, 信孝 | ja |
dc.contributor.alternative | 武田, 篤 | ja |
dc.contributor.alternative | 望月, 秀樹 | ja |
dc.contributor.alternative | 永井, 将弘 | ja |
dc.contributor.alternative | 髙橋, 良輔 | ja |
dc.date.accessioned | 2019-06-24T08:54:02Z | - |
dc.date.available | 2019-06-24T08:54:02Z | - |
dc.date.issued | 2019-03 | - |
dc.identifier.issn | 1353-8020 | - |
dc.identifier.uri | http://hdl.handle.net/2433/242223 | - |
dc.description.abstract | Background: Rasagiline is a monoamine oxidase type-B inhibitor in development in Japan for Parkinson's disease (PD). The objective of this Phase 3, randomized, double-blind study was to evaluate the efficacy and safety of rasagiline in Japanese patients with early PD (NCT02337725). Methods: Patients were 30–79 years old with a diagnosis of PD within 5 years. Following a two-week placebo run-in period, patients were randomized 1:1 to receive rasagiline (1 mg/day) or placebo for up to 26 weeks. The primary endpoint was change from baseline in the MDS-UPDRS Part II + III total score (TS). Secondary endpoints included the MDS-UPDRS Parts II + III, III, II, and I TS and safety. Results: In total, 118 patients were randomized to rasagiline and 126 to placebo. Patient characteristics at baseline were similar in both groups. The change from baseline in the MDS-UPDRS Part II + III TS was significantly greater in the rasagiline vs. placebo group (rasagiline-placebo: −6.39, 95% CI: −8.530, −4.250; P < 0.0001). The mean changes from baseline in the MDS-UPDRS Part II + III, Part III and Part II TS were lower at treatment visits between weeks 6 and 26 in the rasagiline vs. placebo groups. The overall incidence of treatment-emergent adverse events (TEAEs) was 62.4% and 52.4% in the rasagiline and placebo groups, respectively; most frequent TEAE was nasopharyngitis (15.4% and 15.1%). Conclusion: Treatment with oral rasagiline 1 mg/day was effective and well-tolerated in Japanese patients with early PD, with a significantly greater improvement in the MDS-UPDRS Part II + III TS vs. placebo, and a similar safety profile. | en |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Elsevier BV | en |
dc.rights | © 2018 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/BY-NC-ND/4.0/). | en |
dc.subject | MAO-B inhibitor | en |
dc.subject | Rasagiline | en |
dc.subject | Japanese | en |
dc.subject | Parkinson's disease | en |
dc.subject | MDS-UPDRS | en |
dc.title | Rasagiline monotherapy in early Parkinson's disease: A phase 3, randomized study in Japan | en |
dc.type | journal article | - |
dc.type.niitype | Journal Article | - |
dc.identifier.jtitle | Parkinsonism & Related Disorders | - |
dc.identifier.volume | 60 | - |
dc.identifier.spage | 146 | - |
dc.identifier.epage | 152 | - |
dc.relation.doi | 10.1016/j.parkreldis.2018.08.024 | - |
dc.textversion | publisher | - |
dc.identifier.pmid | 30205936 | - |
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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