Efficacy and safety of tegoprazan (LXI-15028) vs. esomeprazole in patients with erosive esophagitis: A multicenter, randomized, double-blind, non-inferiority phase Ⅲ trial

作者：Huiyun Zhu, Qian Xue, Yingxiao Song, Zhenyu Zhang, Xing Li, Shengxiang Lyu, Qiang Zhan, Fei Liu, Lungen Lu, Liang Zhong, Weixing Chen, Dong Shao, Yanbing Ding, Deliang Liu, Xiaozhong Yang, Zhiming Huang, Zhaoshen Li, Yiqi Du · 发表于：Chinese Medical Journal · 年份：2024 · DOI：10.1097/cm9.0000000000003276 · 被引用次数：11 · 研究领域：Gastroesophageal reflux and treatments、Eosinophilic Esophagitis、Dental Erosion and Treatment

BACKGROUND: An evidence gap still exists regarding the efficacy and safety of tegoprazan in patients with erosive esophagitis (EE) in China. This study aimed to verify the efficacy and safety of tegoprazan vs . esomeprazole in patients with EE in China. METHODS: This study was a multicenter, randomized, double-blind, parallel, active-controlled, non-inferiority phase III trial of patients with EE randomized 1:1 to tegoprazan 50 mg/day vs . esomeprazole 40 mg/day. This study was conducted in 32 sites between October 24, 2018 and October 18, 2019. The primary endpoint was the cumulative endoscopic healing rate at week 8. The secondary endpoint included endoscopic healing rate at week 4, changes in the reflux disease questionnaire (RDQ) and gastroesophageal reflux disease health-related quality of life (GERD-HRQL) scores, and symptom improvement. RESULTS: A total of 261 patients were randomized: 132 to the tegoprazan group and 129 to the esomeprazole group. The cumulative endoscopic healing rate at 8 weeks in the tegoprazan group was non-inferior to that of the esomeprazole group (91.1% vs . 92.8%, difference: -1.7%, 95% confidence interval [CI]: -8.5%, 5.0%, P = 0.008). There were no statistically significant differences in the changes in RDQ (total, severity, and frequency) and GERD-HRQL scores between the two groups (all P >0.05). The percentages of days without symptoms, including daytime and nighttime symptoms based on patients' diaries, were similar between the two groups ...