Efficacy of keverprazan for duodenal ulcer: A phase II randomized, double-blind, parallel-controlled trial.

Nian-di Tan, Xiao-Wei Liu, Cheng-Xia Liu, Sheng-Bao Li, Hong-Hui Chen, Xing Li, Hao Wu, Ai-Jun Liao, Yan-Bo Zhen, Peng-Zhen Shen, Li-Juan Huo, Hong-Ling Liu, Rui-Hua Shi, Bing-Qiang Zhang, Zhen-Yu Zhang, Jian-Ning Wang, Qiang Zhan, Hong Deng, Xu Shu, Bi-Guang Tuo, Qi-Zhi Wang, Shi-Yu Du, Ling-Zhi Qi, Guo-Xin Zhang, Qiong Peng, Bang-Mao Wang, Bin Ye, Min-Hu Chen, Ying-Lian Xiao

Journal: Journal of gastroenterology and hepatology 2022;37(11):2060-2066

PMID: 36068945

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Abstract

BACKGROUND AND AIM

Considering the limitation of varying acid suppression of proton pump inhibitors, this study was aimed to assess the efficacy, safety, and dose-effect relationship of keverprazan, a novel potassium-competitive acid blocker, in the treatment of duodenal ulcer (DU) compared with lansoprazole.

METHODS

A randomized, double-blind, double-dummy, multicenter, low-dose, high-dose, and positive-drug parallel-controlled study was conducted to verify the non-inferiority of keverprazan (20 or 30 mg) to lansoprazole of 30 mg once daily for 4 to 6 weeks and dose-effect relationship of keverprazan in the treatment of patients with active DU confirmed by endoscopy.

RESULTS

Of the 180 subjects randomized, including 55 cases in the keverprazan_20 mg group, 61 cases in the keverprazan_30 mg group, and 64 cases in the lansoprazole_30 mg group, 168 subjects (93.33%) completed the study. The proportions of healed DU subjects in the keverprazan_20 mg, keverprazan_30 mg, and lansoprazole_30 mg groups were respectively 87.27%, 90.16%, and 79.69% at week 4 (P = 0.4595) and were respectively 96.36%, 98.36%, and 92.19% at week 6 (P = 0.2577). The incidence of adverse events in the keverprazan_20 mg group was lower than that in the lansoprazole_30 mg (P = 0.0285) and keverprazan_30 mg groups (P = 0.0398).

CONCLUSIONS

Keverprazan was effective and non-inferior to lansoprazole in healing DU. Based on the comparable efficacy and safety data, keverprazan of 20 mg once daily is recommended for the follow-up study of acid-related disorders. (Trial registration number: ChiCTR2100043455.).

Address: Department of Gastroenterology, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, China.; Department of Gastroenterology, Xiangya Hospital Central South University, Changsha, Hunan Province, China.; Department of Gastroenterology, Binzhou Medical University Hospital, Binzhou, Shandong Province, China.; Department of Gastroenterology, Taihe Hospital, Shiyan, Hubei Province, China.; Department of Gastroenterology, The Second Hospital, University of South China, Hengyang, Hunan Province, China.; Department of Gastroenterology, Jiangxi Pingxiang People's Hospital, Pingxiang, Jiangxi Province, China.; Department of Gastroenterology, The Second Affiliated Hospital, WenZhou Medical University, Wenzhou, Zhejiang Province, China.; Department of Gastroenterology, The First Affiliated Hospital of University of South China, Hengyang, Hunan Province, China.; Department of Gastroenterology, Jinan Central Hospital, Jinan, Shandong Province, China.; Department of Gastroenterology, Zigong Fourth People's Hospital, Zigong, Sichuan Province, China.; Department of Gastroenterology, First Hospital of Shanxi Medical University, Taiyuan, Shanxi Province, China.; Department of Gastroenterology, Luo Yang First People's Hospital, Luoyang, Henan Province, China.; Department of Gastroenterology, Zhongda Hospital Southeast University, Nanjing, Jiangsu Province, China.; Department of Gastroenterology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.; Department of Gastroenterology, Nanjing First Hospital, Nanjing, Jiangsu Province, China.; Department of Gastroenterology, Nanjing Jiangning Hospital, Nanjing, Jiangsu Province, China.; Department of Gastroenterology, Wuxi People's Hospital Affiliated to Nanjing Medical University, Wuxi, Jiangsu Province, China.; Department of Gastroenterology, People's Hospital of Deyang City, Deyang, Sichuan Province, China.; Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.; Department of Gastroenterology, Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou Province, China.; Department of Gastroenterology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui Province, China.; Department of Gastroenterology, China-Japan Friendship Hospital, Beijing, China.; Department of Gastroenterology, Jilin Province People's Hospital, Changchun, Jilin Province, China.; Department of Gastroenterology, Jiangsu Province Hospital, Nanjing, Jiangsu Province, China.; Department of Gastroenterology, The Third Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, China.; Department of Gastroenterology, General Hospital, Tianjin Medical University, Tianjin, China.; Department of Gastroenterology, Lishui Municipal Central Hospital, Lishui, Zhejiang Province, China.

DOI: 10.1111/jgh.16000

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MeSH Terms: Humans, Duodenal Ulcer, Anti-Ulcer Agents, Follow-Up Studies, Lansoprazole, Proton Pump Inhibitors, Double-Blind Method, 2-Pyridinylmethylsulfinylbenzimidazoles