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

埃索美拉唑 医学 格尔德 内科学 随机对照试验 不利影响 胃肠病学 入射(几何) 食管炎 临床终点 回流 疾病 光学 物理
作者
Qianjun Zhuang,Aijun Liao,Qingling He,Chengxia Liu,Changqing Zheng,Xing Li,Youli Liu,Bangmao Wang,Side Liu,Yan Zhang,Rong Lin,Huixin Chen,Min Deng,Yanping Tang,Chiyi He,Weijie Dai,Haitao Tang,Lei Gong,LI Liang-ping,Baohong Xu,Changqing Yang,Bingxi Zhou,Dongxing Su,Qinghong Guo,Bin Li,Yongjian Zhou,Xiaoyan Wang,Sujuan Fei,Huili Wu,Sichen Wei,Zhihong Peng,Jianning Wang,Yanqing Li,Hong Wang,Tianwei Deng,Hejun Zhang,Fangfang Li,Minhu Chen,Ying Xiao
出处
期刊:Journal of Gastroenterology and Hepatology [Wiley]
卷期号:39 (4): 658-666 被引量:4
标识
DOI:10.1111/jgh.16471
摘要

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.
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