%0 Clinical Trial, Phase III
%T The efficacy and safety of fexuprazan in treating erosive esophagitis: a phase III, randomized, double-blind, multicenter study.
%A Zhuang Q
%A Liao A
%A He Q
%A Liu C
%A Zheng C
%A Li X
%A Liu Y
%A Wang B
%A Liu S
%A Zhang Y
%A Lin R
%A Chen H
%A Deng M
%A Tang Y
%A He C
%A Dai W
%A Tang H
%A Gong L
%A Li L
%A Xu B
%A Yang C
%A Zhou B
%A Su D
%A Guo Q
%A Li B
%A Zhou Y
%A Wang X
%A Fei S
%A Wu H
%A Wei S
%A Peng Z
%A Wang J
%A Li Y
%A Wang H
%A Deng T
%A Ding S
%A Li F
%A Chen M
%A Xiao Y
%J J Gastroenterol Hepatol
%V 39
%N 4
%D 2024 Apr 22
%M 38251791
%F 4.369
%R 10.1111/jgh.16471
%X <B>OBJECTIVE: </B>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).<BR><B>METHODS: </B>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.<BR><B>RESULTS: </B>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.<BR><B>CONCLUSIONS: </B>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.