The efficacy and safety of keverprazan, a novel potassium-competitive acid blocker, in treating erosive oesophagitis: a phase III, randomised, double-blind multicentre study.

Yang Wang, Yinglian Xiao, Minhu Chen, Huixin Chen, Hekun Yin, Min Xu, Zhili Wen, Xinpu Miao, Qinghong Guo, Min Xia, Songfeng Chen, Yan Zhang, Shengbao Li, Xing Li, Chengxia Liu, Fangfang Li, Aijun Liao, Honghui Chen, Deliang Liu

Journal: Alimentary pharmacology & therapeutics 2022;55(12):1524-1533

PMID: 35505467

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Abstract

BACKGROUND

Keverprazan is a novel potassium-competitive acid blocker (P-CAB) with a strong acid-suppressive capacity that may provide clinical benefit in acid-related diseases.

AIMS

This study aimed to explore the non-inferior efficacy and safety of keverprazan to lansoprazole in treating erosive oesophagitis (EO).

METHODS

This was a phase III, randomised, double-blind multicentre study. Patients were randomised to receive keverprazan 20 mg once daily or lansoprazole 30 mg once daily for 4-8 weeks. EO healing rates and adverse events (AEs) were compared between the keverprazan group and the lansoprazole group.

RESULTS

A total of 238 patients comprised the full analysis set (FAS) while 221 patients comprised the per-protocol set (PPS). For FAS analysis, the EO healing rates at week 8 were 95.8% (114/119) and 89.9% (107/119) for keverprazan and lansoprazole respectively. For PPS analysis, the EO healing rates at week 8 were 99.1% (110/111) and 92.7% (102/110) for keverprazan and lansoprazole respectively. Non-inferiority of keverprazan compared with lansoprazole according to EO healing rates at 8 weeks was demonstrated in both FAS (difference: 5.8% [95% CI: -0.6% to 12.3%]; p = 0.081) and PPS (difference: 6.1% [95% CI: 1.1%-11.2%]; p = 0.018) analysis. Drug-related AEs were reported in 34.5% (41/119) patients of the keverprazan group and 25.2% (30/119) patients of the lansoprazole group with no significant difference (p = 0.156). No severe AE happened in the keverprazan group.

CONCLUSIONS

This study demonstrated the non-inferior efficacy of keverprazan to lansoprazole in treating EO. The incidences of drug-related AEs were comparable between keverprazan and lansoprazole.

Address: Department of Gastroenterology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.; Department of Gastroenterology, The Second Xiangya Hospital of Central South University, Changsha, Hunan Province, China.; Department of Gastroenterology, The Second Affiliated Hospital of University of South China, Hengyang, Hunan Province, China.; Department of Gastroenterology, The First Affiliated Hospital of University of South China, Hengyang, Hunan Province, China.; Department of Gastroenterology, Chenzhou First People's Hospital, Chenzhou, Hunan Province, China.; Department of Gastroenterology, Binzhou Medical University Hospital, Binzhou, Shandong Province, China.; Department of Gastroenterology, JiangXi PingXiang People's Hospital, Pingxiang, Jiangxi Province, China.; Department of Gastroenterology, Taihe Hospital, Shiyan, Hubei Province, China.; Department of Gastroenterology, Zigong Fourth People's Hospital, Zigong, Sichuan Province, China.; Department of Gastroenterology, Changzhou First People's Hospital Changzhou, Changzhou, Jiangsu Province, China.; Department of Gastroenterology, Wuxi People's Hospital, Wuxi, Jiangsu Province, China.; Department of Gastroenterology, The First Hospital of Lanzhou University, Lanzhou, Gansu Province, China.; Department of Gastroenterology, Hainan General Hospital, Haikou, Hainan Province, China.; Department of Gastroenterology, The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.; Department of Gastroenterology, Affiliated Hospital of Jiangsu University, Jiangsu Province, China.; Department of Gastroenterology, Jiangmen Central Hospital, Jiangmen, China.; Department of Gastroenterology, Huizhou Central People's Hospital, Huizhou, China.

DOI: 10.1111/apt.16959

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MeSH Terms: 2-Pyridinylmethylsulfinylbenzimidazoles, Anti-Ulcer Agents, Double-Blind Method, Esophagitis, Humans, Lansoprazole, Peptic Ulcer, Potassium, Proton Pump Inhibitors, Treatment Outcome