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

Yinglian Xiao, Shutian Zhang, Ning Dai, Guijun Fei, Khean Lee Goh, Hoon Jai Chun, Bor-Shyang Sheu, Chui Fung Chong, Nobuo Funao, Wen Zhou, Minhu Chen

Research output: Contribution to journalArticle

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. Trial registration number: NCT02388724.

Original languageEnglish
JournalGut
DOIs
Publication statusAccepted/In press - 2019 Jan 1

Fingerprint

Lansoprazole
Esophagitis
Double-Blind Method
Multicenter Studies
Safety
1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine
2,4-Dichlorophenoxyacetic Acid
Los Angeles
Therapeutics

All Science Journal Classification (ASJC) codes

  • Gastroenterology

Cite this

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. In: Gut. 2019.
@article{9383a2e4ece940dfb594e056516f3428,
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",
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. Trial registration number: NCT02388724.",
author = "Yinglian Xiao and Shutian Zhang and Ning Dai and Guijun Fei and Goh, {Khean Lee} and Chun, {Hoon Jai} and Bor-Shyang Sheu and Chong, {Chui Fung} and Nobuo Funao and Wen Zhou and Minhu Chen",
year = "2019",
month = "1",
day = "1",
doi = "10.1136/gutjnl-2019-318365",
language = "English",
journal = "Gut",
issn = "0017-5749",
publisher = "BMJ Publishing Group",

}

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.

In: Gut, 01.01.2019.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Phase III, randomised, double-blind, multicentre study to evaluate the efficacy and safety of vonoprazan compared with lansoprazole in Asian patients with erosive oesophagitis

AU - Xiao, Yinglian

AU - Zhang, Shutian

AU - Dai, Ning

AU - Fei, Guijun

AU - Goh, Khean Lee

AU - Chun, Hoon Jai

AU - Sheu, Bor-Shyang

AU - Chong, Chui Fung

AU - Funao, Nobuo

AU - Zhou, Wen

AU - Chen, Minhu

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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. Trial registration number: NCT02388724.

AB - 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. Trial registration number: NCT02388724.

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