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The efficacy and safety of fexuprazan in treating erosive esophagitis: a phase III, randomized, double-blind, multicenter study.
Zhuang, Qianjun; Liao, Aijun; He, Qingling; Liu, Chengxia; Zheng, Changqing; Li, Xing; Liu, Youli; Wang, Bangmao; Liu, Side; Zhang, Yan; Lin, Rong; Chen, Huixin; Deng, Min; Tang, Yanping; He, Chiyi; Dai, Weijie; Tang, Haitao; Gong, Lei; Li, Liangping; Xu, Baohong; Yang, Changqing; Zhou, Bingxi; Su, Dongxing; Guo, Qinghong; Li, Bin; Zhou, Yongjian; Wang, Xiaoyang; Fei, Sujuan; Wu, Huili; Wei, Sichen; Peng, Zhihong; Wang, Jianning; Li, Yanqing; Wang, Hong; Deng, Tianwei; Ding, Shigang; Li, Fangfang; Chen, Minhu; Xiao, Yinglian.
Affiliation
  • Zhuang Q; Department of Gastroenterology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.
  • Liao A; Department of Gastroenterology, The First Affiliated Hospital of University of South China, Hengyang, Hunan, China.
  • He Q; Department of Gastroenterology, The Second People's Hospital of Yibin, Yibin, Sichuan, China.
  • Liu C; Department of Gastroenterology, Binzhou Medical University Hospital, Binzhou, Shandong, China.
  • Zheng C; Department of Gastroenterology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, China.
  • Li X; Department of Gastroenterology, Pingxiang People's Hospital, Pingxiang, Jiangxi, China.
  • Liu Y; Department of Gastroenterology, Xuancheng People's Hospital, Xuancheng, Anhui, China.
  • Wang B; Department of Gastroenterology, Tianjin Medical University General Hospital, Tianjin, China.
  • Liu S; Department of Gastroenterology, Nanfang Hospital, Guangzhou, Guangdong, China.
  • Zhang Y; Department of Gastroenterology, Zigong Fourth People's Hospital, Zigong, Sichuan, China.
  • Lin R; Department of Gastroenterology, Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China.
  • Chen H; Department of Gastroenterology, Huizhou Municipal Central Hospital, Huizhou, Guangdong, China.
  • Deng M; Department of Gastroenterology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
  • Tang Y; Department of Gastroenterology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.
  • He C; Department of Gastroenterology, The First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, China.
  • Dai W; Department of Gastroenterology, Huai'an First People's Hospital, Huai'an, Jiangsu, China.
  • Tang H; Department of Gastroenterology, Lu'an People's Hospital, Lu'an, Anhui, China.
  • Gong L; Department of Gastroenterology, Wuxi Second People's Hospital, Wuxi, Jiangsu, China.
  • Li L; Department of Gastroenterology, Sichuan Province People's Hospital, Chengdu, Sichuan, China.
  • Xu B; Department of Gastroenterology, Beijing Luhe Hospital Capital Medical University, Beijing, China.
  • Yang C; Department of Gastroenterology, Tongji Hospital of Tongji University, Shanghai, China.
  • Zhou B; Department of Gastroenterology, Henan Provincial People's Hospital, Zhengzhou, Henan, China.
  • Su D; Department of Gastroenterology, The Second Nanning People's Hospital, Nanning, Guangxi, China.
  • Guo Q; Department of Gastroenterology, The First Hospital of Lanzhou University, Lanzhou, Gansu, China.
  • Li B; Department of Gastroenterology, Affiliated Hospital of Guilin Medical University, Guilin, Guangxi, China.
  • Zhou Y; Department of Gastroenterology, Guangzhou First People's Hospital, Guangzhou, Guangdong, China.
  • Wang X; Department of Gastroenterology, The Third Xiangya Hospital of Central South University, Changsha, Hunan, China.
  • Fei S; Department of Gastroenterology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China.
  • Wu H; Department of Gastroenterology, Zhengzhou Central Hospital, Zhengzhou, Henan, China.
  • Wei S; Department of Gastroenterology, Cangzhou Central Hospital, Cangzhou, Hebei, China.
  • Peng Z; Department of Gastroenterology, The Southwest Hospital of Army Medical University, Chongqing, China.
  • Wang J; Department of Gastroenterology, Nanjing Jiangning Hospital, Nanjing, Jiangsu, China.
  • Li Y; Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China.
  • Wang H; Department of Gastroenterology, Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou, China.
  • Deng T; Department of Gastroenterology, Chongqing University Three Gorges Hospital, Chongqing, China.
  • Ding S; Department of Gastroenterology, Peking University Third Hospital, Beijing, China.
  • Li F; Department of Gastroenterology, Chenzhou First People's Hospital, Chenzhou, Hunan, China.
  • Chen M; Department of Gastroenterology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.
  • Xiao Y; Department of Gastroenterology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.
J Gastroenterol Hepatol ; 39(4): 658-666, 2024 Apr.
Article in En | MEDLINE | ID: mdl-38251791
ABSTRACT
BACKGROUND AND

AIM:

Fexuprazan 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).

METHODS:

This 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.

RESULTS:

A 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.

CONCLUSION:

This 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.
Subject(s)
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Peptic Ulcer / Pyrroles / Esophagitis, Peptic / Gastroesophageal Reflux / Amines Type of study: Clinical_trials / Guideline Limits: Humans Language: En Journal: J Gastroenterol Hepatol Journal subject: GASTROENTEROLOGIA Year: 2024 Document type: Article Affiliation country: China Country of publication: Australia
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Peptic Ulcer / Pyrroles / Esophagitis, Peptic / Gastroesophageal Reflux / Amines Type of study: Clinical_trials / Guideline Limits: Humans Language: En Journal: J Gastroenterol Hepatol Journal subject: GASTROENTEROLOGIA Year: 2024 Document type: Article Affiliation country: China Country of publication: Australia