Efficacy and Safety of Keverprazan Compared With Lansoprazole in the Treatment of Duodenal Ulcer: A Phase III, Randomized, Double-Blind, Multicenter Trial.

Yan-Ping Tang, Ying-Lian Xiao, Min-Hu Chen, Zhen-Yu Zhang, Yan Zhang, Xiao-Wei Liu, Hui-Xin Chen, Xing Li, You-Li Liu, Min Xia, Nian-di Tan, Sheng-Bao Li, Qing-Hong Guo, Fang-Fang Li, Hong-Hui Chen, Hao Wu, Cheng-Xia Liu, Ai-Jun Liao, Xin-Pu Miao

Journal: Clinical and translational gastroenterology 2023;14(7):e00602

PMID: 37235793

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Abstract

INTRODUCTION

Keverprazan is a novel potassium-competitive acid blocker for the treatment of acid-related disorders requiring potent acid inhibition. This study aimed to establish the noninferiority of keverprazan to lansoprazole in the treatment of patients with duodenal ulcer (DU).

METHODS

In this phase III, double-blind, multicenter study, 360 Chinese patients with endoscopically confirmed active DU were randomized 1:1 to take either keverprazan (20 mg) or lansoprazole (30 mg) treatment for up to 6 weeks. The primary end point was DU healing rate at week 6. The secondary end point was DU healing rate at week 4. Symptom improvement and safety were also assessed.

RESULTS

Based on the full analysis set, the cumulative healing rates at week 6 were 94.4% (170/180) and 93.3% (166/178) for keverprazan and lansoprazole, respectively (difference: 1.2%; 95% confidence intervel: -4.0%-6.5%). At week 4, the respective healing rates were 83.9% (151/180) and 80.3% (143/178). In the per protocol set, the 6-week healing rates in keverprazan and lansoprazole groups were 98.2% (163/166) and 97.6% (163/167), respectively (difference: 0.6%; 95% confidence intervel: -3.1%-4.4%); the 4-week healing rates were respectively 86.8% (144/166) and 85.6% (143/167). Keverprazan was noninferior to lansoprazole in DU healing after the treatment for 4 and 6 weeks. The incidence of treatment-emergent adverse events was comparable among groups.

DISCUSSION

Keverprazan 20 mg had a good safety profile and was noninferior to lansoprazole 30 mg once daily for DU healing.

Address: Department of Gastroenterology, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.; Department of Gastroenterology, Hainan General Hospital, Haikou, China.; Department of Gastroenterology, The First Hospital, University of South China, Hengyang, China.; Department of Gastroenterology, Binzhou Medical University Hospital, Binzhou, China.; Department of Gastroenterology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China.; Department of Gastroenterology, The Second Affiliated Hospital, University of South China, Hengyang, China.; Department of Gastroenterology, Chenzhou First People's Hospital, Chenzhou, China.; Department of Gastroenterology, The First Hospital of Lanzhou University, Lanzhou, China.; Department of Gastroenterology, Taihe Hospital, Shiyan, China.; Department of Gastroenterology, Tianjin Hospital of ITCWM, Nankai Hospital, Tianjin, China.; Department of Gastroenterology, Wuxi People's Hospital, Wuxi, China.; Department of Gastroenterology, Xuancheng People's Hospital, Xuancheng, China.; Department of Gastroenterology, JiangXi PingXiang People's Hospital, Pingxiang, China.; Department of Gastroenterology, Huizhou Central People's Hospital, Huizhou, China.; Department of Gastroenterology, Xiangya Hospital Central South University, Changsha, China.; Department of Gastroenterology, The Fourth People's Hospital of Zigong City, Zigong, China.; Department of Gastroenterology, Nanjing First Hospital, Nanjing, China.

DOI: 10.14309/ctg.0000000000000602

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MeSH Terms: Humans, Lansoprazole, Duodenal Ulcer, Anti-Ulcer Agents, Double-Blind Method