The efficacy and safety of fexuprazan in treating erosive esophagitis: a phase III, randomized, double-blind, multicenter study

被引：7

作者：

Zhuang, Qianjun ^{[1
]}

Liao, Aijun ^{[5
]}

He, Qingling ^{[5
,8
]}

Liu, Chengxia ^{[11
]}

Zheng, Changqing ^{[13
]}

Li, Xing ^{[14
]}

Liu, Youli ^{[15
,18
]}

Wang, Bangmao ^{[8
]}

Liu, Side ^{[2
]}

Zhang, Yan ^{[9
]}

Lin, Rong ^{[25
]}

Chen, Huixin ^{[4
]}

Deng, Min ^{[4
]}

Tang, Yanping ^{[19
]}

He, Chiyi ^{[16
]}

Dai, Weijie ^{[26
]}

Tang, Haitao ^{[17
]}

Gong, Lei ^{[27
]}

Li, Liangping ^{[10
]}

Xu, Baohong ^{[20
]}

Yang, Changqing ^{[22
]}

Zhou, Bingxi ^{[30
]}

Su, Dongxing ^{[32
]}

Guo, Qinghong ^{[34
]}

Li, Bin ^{[33
]}

Zhou, Yongjian ^{[3
]}

Wang, Xiaoyang ^{[6
]}

Fei, Sujuan ^{[28
]}

Wu, Huili ^{[31
]}

Wei, Sichen ^{[35
]}

Peng, Zhihong ^{[23
]}

Wang, Jianning ^{[29
]}

Li, Yanqing ^{[12
]}

Wang, Hong ^{[36
]}

Deng, Tianwei ^{[24
]}

Ding, Shigang ^{[21
]}

Li, Fangfang ^{[7
]}

Chen, Minhu ^{[1
]}

Xiao, Yinglian ^{[1
]}

机构：

[1] Sun Yat Sen Univ, Affiliated Hosp 1, Dept Gastroenterol, Guangzhou, Guangdong, Peoples R China

[2] Nanfang Hosp, Dept Gastroenterol, Guangzhou, Peoples R China

[3] Guangzhou First Peoples Hosp, Dept Gastroenterol, Guangzhou, Peoples R China

[4] Huizhou Municipal Cent Hosp, Dept Gastroenterol, Huizhou, Guangdong, Peoples R China

[5] Univ South China, Affiliated Hosp 1, Dept Gastroenterol, Hengyang, Peoples R China

[6] Cent South Univ, Xiangya Hosp 3, Dept Gastroenterol, Changsha, Peoples R China

[7] Chenzhou First Peoples Hosp, Dept Gastroenterol, Chenzhou, Hunan, Peoples R China

[8] Second Peoples Hosp Yibin, Dept Gastroenterol, Yibin, Peoples R China

[9] Zigong Fourth Peoples Hosp, Dept Gastroenterol, Zigong, Peoples R China

[10] Sichuan Prov Peoples Hosp, Dept Gastroenterol, Chengdu, Sichuan, Peoples R China

[11] Binzhou Med Univ Hosp, Dept Gastroenterol, Binzhou, Peoples R China

[12] Shandong Univ, Qilu Hosp, Dept Gastroenterol, Jinan, Shandong, Peoples R China

[13] China Med Univ, Shengjing Hosp, Dept Gastroenterol, Shenyang, Liaoning, Peoples R China

[14] Pingxiang Peoples Hosp, Dept Gastroenterol, Pingxiang, Jiangxi, Peoples R China

[15] Xuancheng Peoples Hosp, Dept Gastroenterol, Xuancheng, Peoples R China

[16] First Affiliated Hosp, Bengbu Med Coll, Dept Gastroenterol, Bengbu, Peoples R China

[17] Luan Peoples Hosp, Dept Gastroenterol, Luan, Anhui, Peoples R China

[18] Tianjin Med Univ, Gen Hosp, Dept Gastroenterol, Tianjin, Peoples R China

[19] Tianjin Univ Tradit Chinese Med, Dept Gastroenterol, Teaching Hosp 1, Tianjin, Peoples R China

[20] Capital Med Univ, Dept Gastroenterol, Beijing Luhe Hosp, Beijing, Peoples R China

[21] Peking Univ Third Hosp, Dept Gastroenterol, Beijing, Peoples R China

[22] Tongji Univ, Dept Gastroenterol, Tongji Hosp, Shanghai, Peoples R China

[23] Army Med Univ, Southwest Hosp, Dept Gastroenterol, Chongqing, Peoples R China

[24] Chongqing Univ, Dept Gastroenterol, Gorges Hosp 3, Chongqing, Peoples R China

[25] Huazhong Univ Sci & Technol, Dept Gastroenterol, Union Hosp, Tongji Med Coll, Wuhan, Hubei, Peoples R China

[26] Huaian First Peoples Hosp, Dept Gastroenterol, Huaian, Peoples R China

[27] Wuxi Second Peoples Hosp, Dept Gastroenterol, Wuxi, Peoples R China

[28] Xuzhou Med Univ, Affiliated Hosp, Dept Gastroenterol, Xuzhou, Peoples R China

[29] Nanjing Jiangning Hosp, Dept Gastroenterol, Nanjing, Jiangsu, Peoples R China

[30] Henan Prov Peoples Hosp, Dept Gastroenterol, Zhengzhou, Peoples R China

[31] Zhengzhou Cent Hosp, Dept Gastroenterol, Zhengzhou, Henan, Peoples R China

[32] Second Nanning Peoples Hosp, Dept Gastroenterol, Nanning, Peoples R China

[33] Guilin Med Univ, Affiliated Hosp, Dept Gastroenterol, Guilin, Guangxi, Peoples R China

[34] Lanzhou Univ, Dept Gastroenterol, Hosp 1, Lanzhou, Gansu, Peoples R China

[35] Cangzhou Cent Hosp, Dept Gastroenterol, Cangzhou, Hebei, Peoples R China

[36] Zunyi Med Univ, Affiliated Hosp, Dept Gastroenterol, Zunyi, Guizhou, Peoples R China

来源：

JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY | 2024年 / 39卷 / 04期

关键词：

GASTROESOPHAGEAL-REFLUX DISEASE; PROTON-PUMP INHIBITORS; ESOMEPRAZOLE; 40; MG; SYMPTOM RELIEF; CLINICAL-TRIAL; ACID CONTROL; LANSOPRAZOLE; OMEPRAZOLE; POPULATION; PREVALENCE;

D O I：

10.1111/jgh.16471

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

Background and AimFexuprazan is a novel potassium-competitive acid blocker (P-CAB). This study aimed to explore the noninferior efficacy and safety of fexuprazan to esomeprazole in treating erosive esophagitis (EE).MethodsThis was a phase III, randomized, double-blind multicenter study. Patients with endoscopically confirmed EE were randomized to receive fexuprazan 40 mg or esomeprazole 40 mg once a daily for 4-8 weeks. The healing rates of EE, symptom response, GERD-health-related quality life (GERD-HRQL), and treatment-emergent adverse events (TEAEs) were compared between fexuprazan group and esomeprazole group.ResultsA total of 332 subjects were included in full analysis set (FAS) and 311 in per-protocol set (PPS). The healing rates of fexuprazan and esomeprazole groups at 8 weeks were 88.5% (146/165) and 89.0% (145/163), respectively, in FAS and 97.3% (145/149) and 97.9% (143/146), respectively, in PPS. Noninferiority of fexuprazan compared with esomeprazole according to EE healing rates at 8 weeks was demonstrated in both FAS and PPS analysis. No significant difference was found between groups in EE healing rates at 4 weeks, symptom responses, and changes of GERD-HRQL. The incidence of drug-related AEs was 19.4% (32/165) in fexuprazan arm and 19.6% (32/163) in esomeprazole arm.ConclusionThis study demonstrated noninferior efficacy of fexuprazan to esomeprazole in treating EE. The incidence of TEAEs was similar between fexuprazan and esomeprazole.Trial registration number NCT05813561.ConclusionThis study demonstrated noninferior efficacy of fexuprazan to esomeprazole in treating EE. The incidence of TEAEs was similar between fexuprazan and esomeprazole.Trial registration number NCT05813561.

引用

页码：658 / 666

页数：9

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