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Phase III, randomised, double-blind, multicentre study to evaluate the efficacy and safety of vonoprazan compared with lansoprazole in Asian patients with erosive oesophagitis

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 o...

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Main Authors: Xiao, Yinglian, Zhang, Shutian, Dai, Ning, Fei, Guijun, Goh, Khean Lee, Chun, Hoon Jai, Sheu, Bor Shyang, Chong, Chui Fung, Funao, Nobuo, Zhou, Wen, Chen, Minhu
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Published: BMJ Publishing Group 2019
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R Medicine
Online Access:http://eprints.um.edu.my/24749/
https://doi.org/10.1136/gutjnl-2019-318365
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spelling my.um.eprints.247492020-06-09T06:16:08Z http://eprints.um.edu.my/24749/ Phase III, randomised, double-blind, multicentre study to evaluate the efficacy and safety of vonoprazan compared with lansoprazole in Asian patients with erosive oesophagitis Xiao, Yinglian Zhang, Shutian Dai, Ning Fei, Guijun Goh, Khean Lee Chun, Hoon Jai Sheu, Bor Shyang Chong, Chui Fung Funao, Nobuo Zhou, Wen Chen, Minhu R Medicine 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. © 2020 Author(s). BMJ Publishing Group 2019 Article PeerReviewed Xiao, Yinglian and Zhang, Shutian and Dai, Ning and Fei, Guijun and Goh, Khean Lee and Chun, Hoon Jai and Sheu, Bor Shyang and Chong, Chui Fung and Funao, Nobuo and Zhou, Wen and Chen, Minhu (2019) Phase III, randomised, double-blind, multicentre study to evaluate the efficacy and safety of vonoprazan compared with lansoprazole in Asian patients with erosive oesophagitis. Gut, 69 (2). pp. 224-230. ISSN 0017-5749 https://doi.org/10.1136/gutjnl-2019-318365 doi:10.1136/gutjnl-2019-318365
institution Universiti Malaya
building UM Library
collection Institutional Repository
continent Asia
country Malaysia
content_provider Universiti Malaya
content_source UM Research Repository
url_provider http://eprints.um.edu.my/
topic R Medicine
spellingShingle R Medicine
Xiao, Yinglian
Zhang, Shutian
Dai, Ning
Fei, Guijun
Goh, Khean Lee
Chun, Hoon Jai
Sheu, Bor Shyang
Chong, Chui Fung
Funao, Nobuo
Zhou, Wen
Chen, Minhu
Phase III, randomised, double-blind, multicentre study to evaluate the efficacy and safety of vonoprazan compared with lansoprazole in Asian patients with erosive oesophagitis
description 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. © 2020 Author(s).
format Article
author Xiao, Yinglian
Zhang, Shutian
Dai, Ning
Fei, Guijun
Goh, Khean Lee
Chun, Hoon Jai
Sheu, Bor Shyang
Chong, Chui Fung
Funao, Nobuo
Zhou, Wen
Chen, Minhu
author_facet Xiao, Yinglian
Zhang, Shutian
Dai, Ning
Fei, Guijun
Goh, Khean Lee
Chun, Hoon Jai
Sheu, Bor Shyang
Chong, Chui Fung
Funao, Nobuo
Zhou, Wen
Chen, Minhu
author_sort Xiao, Yinglian
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
title_short Phase III, randomised, double-blind, multicentre study to evaluate the efficacy and safety of vonoprazan compared with lansoprazole in Asian patients with erosive oesophagitis
title_full Phase III, randomised, double-blind, multicentre study to evaluate the efficacy and safety of vonoprazan compared with lansoprazole in Asian patients with erosive oesophagitis
title_fullStr Phase III, randomised, double-blind, multicentre study to evaluate the efficacy and safety of vonoprazan compared with lansoprazole in Asian patients with erosive oesophagitis
title_full_unstemmed Phase III, randomised, double-blind, multicentre study to evaluate the efficacy and safety of vonoprazan compared with lansoprazole in Asian patients with erosive oesophagitis
title_sort phase iii, randomised, double-blind, multicentre study to evaluate the efficacy and safety of vonoprazan compared with lansoprazole in asian patients with erosive oesophagitis
publisher BMJ Publishing Group
publishDate 2019
url http://eprints.um.edu.my/24749/
https://doi.org/10.1136/gutjnl-2019-318365
_version_ 1669008014689959936
score 13.211869

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