替戈拉赞（LXI-15028）与埃索美拉唑治疗糜烂性食管炎患者的疗效和安全性：一项多中心、随机、双盲、非劣效性Ⅲ期试验。
Efficacy and safety of tegoprazan (LXI-15028) vs. esomeprazole in patients with erosive esophagitis: A multicenter, randomized, double-blind, non-inferiority phase Ⅲ trial.
作者信息
Zhu Huiyun, Xue Qian, Song Yingxiao, Zhang Zhenyu, Li Xing, Lyu Shengxiang, Zhan Qiang, Liu Fei, Lu Lungen, Zhong Liang, Chen Weixing, Shao Dong, Ding Yanbing, Liu Deliang, Yang Xiaozhong, Huang Zhiming, Li Zhaoshen, Du Yiqi
机构信息
Department of Gastroenterology, Changhai Hospital of Navy Military Medical University, Shanghai 200433, China.
Department of Gastroenterology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210012, China.
出版信息
Chin Med J (Engl). 2024 Oct 30. doi: 10.1097/CM9.0000000000003276.
BACKGROUND
An evidence gap still exists regarding the efficacy and safety of tegoprazan in Chinese 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 (all P >0.05). In the tegoprazan and esomeprazole groups, 71.5% (93/130) and 61.7% (79/128) of the participants reported adverse events (AEs), 2.3% and 0 experienced serious AEs, while 70.0% and 60.2% had treatment-emergent AEs, respectively.
CONCLUSION
Tegoprazan 50 mg/day demonstrated non-inferior efficacy in healing EE, symptom improvement, and quality of life, and it has similar tolerability compared with esomeprazole 40 mg/day.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03615677.
背景
在中国，关于替戈拉赞治疗糜烂性食管炎（EE）患者的疗效和安全性仍存在证据空白。本研究旨在验证替戈拉赞与埃索美拉唑在中国EE患者中的疗效和安全性。
方法
本研究为一项多中心、随机、双盲、平行、活性药物对照的非劣效性III期试验，将EE患者按1:1随机分为替戈拉赞50mg/天组和埃索美拉唑40mg/天组。本研究于2018年10月24日至2019年10月18日在32个地点进行。主要终点为第8周的累积内镜愈合率。次要终点包括第4周的内镜愈合率、反流疾病问卷（RDQ）和胃食管反流病健康相关生活质量（GERD-HRQL）评分的变化以及症状改善情况。
结果
共261例患者被随机分组：132例进入替戈拉赞组，129例进入埃索美拉唑组。替戈拉赞组第8周的累积内镜愈合率不劣于埃索美拉唑组（91.1%对92.8%，差值：-1.7，95%置信区间[CI]：-8.5，5.0，P=0.008）。两组在RDQ（总分、严重程度和频率）和GERD-HRQL评分变化方面无统计学显著差异（所有P>0.05）。根据患者日记记录，两组无症状天数的百分比，包括白天和夜间症状，相似（所有P>0.05）。在替戈拉赞组和埃索美拉唑组中，分别有71.5%（93/130）和61.7%（79/128）的参与者报告了不良事件（AE），2.3%和0%经历了严重AE，而分别有70.0%和60.2%出现了治疗中出现的AE。
结论
每天50mg替戈拉赞在愈合EE、改善症状和提高生活质量方面显示出非劣效性疗效，并且与每天40mg埃索美拉唑具有相似的耐受性。
试验注册
ClinicalTrials.gov，NCT03615677。
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