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Vonoprazan prevents ulcer recurrence during long-term NSAID therapy: randomised, lansoprazole-controlled non-inferiority and single-blind extension study
http://hdl.handle.net/2241/00152987
http://hdl.handle.net/2241/00152987b813d442-f1b6-4739-9791-fb197062c70a
名前 / ファイル | ライセンス | アクション |
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Gut_67-6-1042 (692.0 kB)
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Item type | Journal Article(1) | |||||
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公開日 | 2018-07-27 | |||||
タイトル | ||||||
タイトル | Vonoprazan prevents ulcer recurrence during long-term NSAID therapy: randomised, lansoprazole-controlled non-inferiority and single-blind extension study | |||||
言語 | ||||||
言語 | eng | |||||
資源タイプ | ||||||
資源 | http://purl.org/coar/resource_type/c_6501 | |||||
タイプ | journal article | |||||
著者 |
Mizokami, Yuji
× Mizokami, Yuji× Oda, Kazunori× Funao, Nobuo× Nishimura, Akira× Soen, Satoshi× Kawai, Takashi× Ashida, Kiyoshi× Sugano, Kentaro |
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著者別名 |
溝上, 裕士
× 溝上, 裕士 |
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抄録 | ||||||
内容記述タイプ | Abstract | |||||
内容記述 | Objective To assess the non-inferiority of vonoprazan to lansoprazole for secondary prevention of non-steroidal anti-inflammatory drug (NSAID)-induced peptic ulcer (PU) and the safety of vonoprazan during extended use. Design A phase 3, 24-week, multicenter, randomised, double-blind (DB), active-controlled study, followed by a phase 3, ≥28 week, multicenter, single-blind, parallel-group extension study (EXT) in outpatients (n=642) receiving long-term NSAID therapy who are at risk of PU recurrence. The patients received vonoprazan (10 mg or 20 mg) or lansoprazole 15 mg once daily. For DB, non-inferiority of the proportion of patients with recurrent PU within 24 weeks was analysed by Farrington and Manning test (significance level 2.5%, non-inferiority margin 8.3%; primary endpoint), recurrent PU within 12 weeks, bleeding and time-to-event of PU (secondary endpoint) and treatment-emergent adverse events (TEAEs). For EXT, TEAEs (primary endpoint), recurrent PU and safety (secondary) were assessed up to 104 weeks for patients in the extension study. Results The non-inferiority of vonoprazan 10 mg and 20 mg to lansoprazole 15 mg was verified (percentage difference –2.2%,95% CI –6.2% to 1.8%, p<0.001; –2.1%,95% CI –6.1% to 2.0%, p<0.001, respectively). The proportion of patients with endoscopically confirmed recurrent PU within 24 weeks was 3.3%, 3.4% and 5.5%, for vonoprazan 10 mg, 20 mg and lansoprazole 15 mg, respectively. No significant safety concerns were identified. Conclusion The non-inferiority of vonoprazan (10 and 20 mg) was verified in patients receiving long-term NSAIDs in DB; it was effective and well tolerated in EXT for longer than 1 year, with a safety profile similar to lansoprazole (15 mg). |
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書誌情報 |
Gut 巻 67, 号 6, p. 1042-1051, 発行日 2018-06 |
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ISSN | ||||||
収録物識別子タイプ | ISSN | |||||
収録物識別子 | 0017-5749 | |||||
書誌レコードID | ||||||
収録物識別子タイプ | NCID | |||||
収録物識別子 | AA00660592 | |||||
PubMed番号 | ||||||
識別子タイプ | PMID | |||||
関連識別子 | 28988197 | |||||
DOI | ||||||
識別子タイプ | DOI | |||||
関連識別子 | 10.1136/gutjnl-2017-314010 | |||||
権利 | ||||||
権利情報 | Open Access This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ | |||||
権利 | ||||||
権利情報 | © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. | |||||
著者版フラグ | ||||||
値 | publisher | |||||
出版者 | ||||||
出版者 | British Society of Gastroenterology | |||||
出版者 | ||||||
出版者 | BMJ Publishing |