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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

Xiao Y 1 , Zhang S 2 , Dai N 3 , Fei G 4 , Goh KL 5 , Chun HJ 6 Show all authors , Sheu BS 7 , Chong CF 8 , Funao N 9 , Zhou W 10 , Chen M 11

Affiliations 

  • 1 Department of Gastroenterology and Hepatology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
  • 2 Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing, China
  • 3 Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Zhejiang, China
  • 4 Department of Gastroenterology, Peking Union Medical College Hospital, Beijing, China
  • 5 Division of Gastroenterology, Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia
  • 6 Division of Gastroenterology and Hepatology, Department of Internal Medicine, Institute of Gastrointestinal Medical Instrument Research, Korea University College of Medicine, Seoul, Republic of Korea
  • 7 Department of Internal Medicine, National Cheng Kung University Hospital and Tainan Hospital, Tainan, Taiwan
  • 8 Gastroenterology Therapeutic Area Unit, Takeda Development Center Asia, Singapore, Singapore
  • 9 Takeda Development Center Japan, Takeda Pharmaceutical Company, Osaka, Japan
  • 10 Department of Clinical Science, Takeda Pharmaceutical Company, Cambridge, Massachusetts, USA
  • 11 Department of Gastroenterology and Hepatology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China chenminhu@mail.sysu.edu.cn
Gut, 2020 02;69(2):224-230.
PMID: 31409606 DOI: 10.1136/gutjnl-2019-318365

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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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