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
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.