Abstract：
OBJECTIVE: 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.
CONCLUSIONS: 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.
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.
CONCLUSIONS: 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.
摘要：
目的：Fexuprazan是一种新型的钾竞争性酸阻滞剂（P-CAB）。本研究旨在探讨非克苏普拉康对埃索美拉唑治疗糜烂性食管炎（EE）的疗效和安全性。
方法：这是第三阶段，随机化，双盲多中心研究。经内窥镜检查确诊为EE的患者随机接受40mg非克苏普拉坦或40mg埃索美拉唑，每天一次，共4-8周。EE的治愈率，症状反应,GERD-健康相关生活质量（GERD-HRQL），我们比较了非索普拉康组和埃索美拉唑组的治疗引起的不良事件(TEAE).
结果：总共332名受试者被纳入完整分析集（FAS），311名受试者被纳入符合方案集（PPS）。非索普拉康组和埃索美拉唑组8周时的治愈率分别为88.5%(146/165)和89.0%(145/163),分别,在FAS中，97.3%(145/149)和97.9%(143/146)，分别,在PPS。在FAS和PPS分析中，根据8周时的EE治愈率，与埃索美拉唑相比，非索普拉坦的非劣效性均得到证实。在4周时，各组之间的EE治愈率没有显着差异。症状反应,GERD-HRQL的变化。药物相关AE的发生率在非索普拉康组为19.4%(32/165)，在埃索美拉唑组为19.6%(32/163)。
结论：本研究证明非索普拉坦治疗EE的疗效不亚于埃索美拉唑。非索普拉赞和埃索美拉唑的TEAE发生率相似。试验注册号NCT05813561。
方法：这是第三阶段，随机化，双盲多中心研究。经内窥镜检查确诊为EE的患者随机接受40mg非克苏普拉坦或40mg埃索美拉唑，每天一次，共4-8周。EE的治愈率，症状反应,GERD-健康相关生活质量（GERD-HRQL），我们比较了非索普拉康组和埃索美拉唑组的治疗引起的不良事件(TEAE).
结果：总共332名受试者被纳入完整分析集（FAS），311名受试者被纳入符合方案集（PPS）。非索普拉康组和埃索美拉唑组8周时的治愈率分别为88.5%(146/165)和89.0%(145/163),分别,在FAS中，97.3%(145/149)和97.9%(143/146)，分别,在PPS。在FAS和PPS分析中，根据8周时的EE治愈率，与埃索美拉唑相比，非索普拉坦的非劣效性均得到证实。在4周时，各组之间的EE治愈率没有显着差异。症状反应,GERD-HRQL的变化。药物相关AE的发生率在非索普拉康组为19.4%(32/165)，在埃索美拉唑组为19.6%(32/163)。
结论：本研究证明非索普拉坦治疗EE的疗效不亚于埃索美拉唑。非索普拉赞和埃索美拉唑的TEAE发生率相似。试验注册号NCT05813561。
