Vonoprazan 10 mg or 20 mg vs. lansoprazole 15 mg as maintenance therapy in Asian patients with healed erosive esophagitis: A randomized controlled trial

Xiao Y 1 , Qian J 2 , Zhang S 3 , Dai N 4 , Chun HJ 5 , Chiu C 6 Show all authors , Chong CF 7 , Funao N 8 , Sakurai Y 8 , Eisner JD 9 , Xie L 10 , Chen M 1

Affiliations 

  • 1 Department of Gastroenterology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong 510062, China
  • 2 Department of Gastroenterology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100006, China
  • 3 Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
  • 4 Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine Zhejiang University, Hangzhou, Zhejiang 310020, China
  • 5 Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, 73 Goryeodae-ro, Seongbuk-gu, Seoul 02841, Republic of Korea
  • 6 Department of Gastroenterology & Hepatology, Linkou Medical Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan 33353, China
  • 7 Takeda Development Center Asia, Singapore 018981, Singapore
  • 8 Takeda Pharmaceutical Company, Chuo-ku, Osaka 540-8645, Japan
  • 9 Takeda Pharmaceuticals International Company, Cambridge, MA, 02142 USA
  • 10 China Medical Team, Takeda China, Beijing 100027, China
Chin Med J (Engl), 2024 Apr 20;137(8):962-971.
PMID: 38654422 DOI: 10.1097/CM9.0000000000003068

Abstract

BACKGROUND: Erosive esophagitis (EE) is a gastroesophageal reflux disease characterized by mucosal breaks in the esophagus. Proton pump inhibitors are widely used as maintenance therapy for EE, but many patients still relapse. In this trial, we evaluated the noninferiority of vonoprazan vs. lansoprazole as maintenance therapy in patients with healed EE.

METHODS: We performed a double-blind, double-dummy, multicenter, phase 3 clinical trial among non-Japanese Asian adults with endoscopically confirmed healed EE from April 2015 to February 2019. Patients from China, South Korea, and Malaysia were randomized to vonoprazan 10 mg or 20 mg once daily or lansoprazole 15 mg once daily for 24 weeks. The primary endpoint was endoscopically confirmed EE recurrence rate over 24 weeks with a noninferiority margin of 10% using a two-sided 95% confidence interval (CI). Treatment-emergent adverse events (TEAEs) were recorded.

RESULTS: Among 703 patients, EE recurrence was observed in 24/181 (13.3%) and 21/171 (12.3%) patients receiving vonoprazan 10 mg or 20 mg, respectively, and 47/184 (25.5%) patients receiving lansoprazole (differences: -12.3% [95% CI, -20.3% to -4.3%] and -13.3% [95% CI, -21.3% to -5.3%], respectively), meeting the primary endpoint of noninferiority to lansoprazole in preventing EE recurrence at 24 weeks. Evidence of superiority (upper bound of 95% CI <0%) was also observed. At 12 weeks, endoscopically confirmed EE recurrence was observed in 5/18, 2/20, and 7/20 of patients receiving vonoprazan 10 mg, vonoprazan 20 mg, and lansoprazole, respectively. TEAEs were experienced by 66.8% (157/235), 69.0% (156/226), and 65.3% (158/242) of patients receiving vonoprazan 10 mg, vonoprazan 20 mg, and lansoprazole, respectively. The most common TEAE was upper respiratory tract infection in 12.8% (30/235) and 12.8% (29/226) patients in vonoprazan 10 mg and 20 mg groups, respectively and 8.7% (21/242) patients in lansoprazole group.

CONCLUSION: Vonoprazan maintenance therapy was well-tolerated and noninferior to lansoprazole for preventing EE recurrence in Asian patients with healed EE.

TRIAL REGISTRATION: https://clinicaltrials.gov; NCT02388737.

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

MeSH terms
Similar publications