Phase III, randomised, double-blind, multicentre study to evaluate the efficacy and safety of vonoprazan compared with lansoprazole in Asian patients with erosive oesophagitis
DC Field | Value | Language |
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dc.contributor.author | Xiao, Yinglian | - |
dc.contributor.author | Zhang, Shutian | - |
dc.contributor.author | Dai, Ning | - |
dc.contributor.author | Fei, Guijun | - |
dc.contributor.author | Goh, Khean-Lee | - |
dc.contributor.author | Chun, Hoon Jai | - |
dc.contributor.author | Sheu, Bor-Shyang | - |
dc.contributor.author | Chong, Chui Fung | - |
dc.contributor.author | Funao, Nobuo | - |
dc.contributor.author | Zhou, Wen | - |
dc.contributor.author | Chen, Minhu | - |
dc.date.accessioned | 2021-08-31T11:28:16Z | - |
dc.date.available | 2021-08-31T11:28:16Z | - |
dc.date.created | 2021-06-18 | - |
dc.date.issued | 2020-02 | - |
dc.identifier.issn | 0017-5749 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/57823 | - |
dc.description.abstract | Objective To establish the non-inferior efficacy of vonoprazan versus lansoprazole in the treatment of Asian patients with erosive oesophagitis (EO). Design In this phase III, double-blind, multicentre study, patients with endoscopically confirmed EO were randomised 1:1 to receive vonoprazan 20 mg or lansoprazole 30 mg, once daily for up to 8 weeks. The primary endpoint was EO healing rate at 8 weeks. The secondary endpoints were EO healing rates at 2 and 4 weeks. Safety endpoints included treatment-emergent adverse events (TEAEs). Results In the vonoprazan (n=238) and lansoprazole (n=230) arms, 8-week EO healing rates were 92.4% and 91.3%, respectively (difference 1.1% (95% CI -3.822% to 6.087%)). The respective 2-week EO healing rates were 75.0% and 67.8% (difference 7.2% (95% CI -1.054% to 15.371%)), and the respective 4-week EO healing rates were 85.3% and 83.5% (difference 1.8% (95% CI -4.763% to 8.395%)). In patients with baseline Los Angeles classification grade C/D, 2-week, 4-week and 8-week EO healing rates were higher with vonoprazan versus lansoprazole (2 weeks: 62.2% vs 51.5%, difference 10.6% (95% CI -5.708% to 27.002%); 4 weeks: 73.3% vs 67.2%, difference 6.2% (95% CI -8.884 to 21.223); and 8 weeks: 84.0% vs 80.6%, difference 3.4% (95% CI -9.187% to 15.993%)). Overall, EO healing rates appeared higher with vonoprazan versus lansoprazole. TEAE rates were 38.1% and 36.6% in the vonoprazan and lansoprazole group, respectively. Conclusion Our findings demonstrate the non-inferior efficacy of vonoprazan versus lansoprazole in terms of EO healing rate at 8 weeks in this population. Safety outcomes were similar in the two treatment arms. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | BMJ PUBLISHING GROUP | - |
dc.subject | COMPETITIVE ACID BLOCKER | - |
dc.subject | GASTROESOPHAGEAL-REFLUX DISEASE | - |
dc.subject | CLINICAL-TRIAL | - |
dc.subject | VS. LANSOPRAZOLE | - |
dc.subject | TAK-438 | - |
dc.subject | PREVALENCE | - |
dc.subject | PHARMACOKINETICS | - |
dc.subject | ESOMEPRAZOLE | - |
dc.subject | INHIBITION | - |
dc.subject | OMEPRAZOLE | - |
dc.title | Phase III, randomised, double-blind, multicentre study to evaluate the efficacy and safety of vonoprazan compared with lansoprazole in Asian patients with erosive oesophagitis | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Chun, Hoon Jai | - |
dc.identifier.doi | 10.1136/gutjnl-2019-318365 | - |
dc.identifier.scopusid | 2-s2.0-85070710736 | - |
dc.identifier.wosid | 000508194700006 | - |
dc.identifier.bibliographicCitation | GUT, v.69, no.2, pp.224 - 230 | - |
dc.relation.isPartOf | GUT | - |
dc.citation.title | GUT | - |
dc.citation.volume | 69 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 224 | - |
dc.citation.endPage | 230 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Gastroenterology & Hepatology | - |
dc.relation.journalWebOfScienceCategory | Gastroenterology & Hepatology | - |
dc.subject.keywordPlus | COMPETITIVE ACID BLOCKER | - |
dc.subject.keywordPlus | GASTROESOPHAGEAL-REFLUX DISEASE | - |
dc.subject.keywordPlus | CLINICAL-TRIAL | - |
dc.subject.keywordPlus | VS. LANSOPRAZOLE | - |
dc.subject.keywordPlus | TAK-438 | - |
dc.subject.keywordPlus | PREVALENCE | - |
dc.subject.keywordPlus | PHARMACOKINETICS | - |
dc.subject.keywordPlus | ESOMEPRAZOLE | - |
dc.subject.keywordPlus | INHIBITION | - |
dc.subject.keywordPlus | OMEPRAZOLE | - |
dc.subject.keywordAuthor | erosive oesophagitis | - |
dc.subject.keywordAuthor | gastric acid | - |
dc.subject.keywordAuthor | gastro-oesophageal reflux disease | - |
dc.subject.keywordAuthor | proton pump inhibition | - |
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