{Reference Type}: Clinical Trial, Phase III
{Title}: The efficacy and safety of fexuprazan in treating erosive esophagitis: a phase III, randomized, double-blind, multicenter study.
{Author}: Zhuang Q;Liao A;He Q;Liu C;Zheng C;Li X;Liu Y;Wang B;Liu S;Zhang Y;Lin R;Chen H;Deng M;Tang Y;He C;Dai W;Tang H;Gong L;Li L;Xu B;Yang C;Zhou B;Su D;Guo Q;Li B;Zhou Y;Wang X;Fei S;Wu H;Wei S;Peng Z;Wang J;Li Y;Wang H;Deng T;Ding S;Li F;Chen M;Xiao Y;
{Journal}: J Gastroenterol Hepatol
{Volume}: 39
{Issue}: 4
{Year}: 2024 Apr 22
{Factor}: 4.369
{DOI}: 10.1111/jgh.16471
{Abstract}: <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.