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

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

doi:10.1097/CM9.0000000000003276

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

Chin Med J (Engl). 2024 Oct 30. doi: 10.1097/CM9.0000000000003276. Online ahead of print.

Authors

Huiyun Zhu¹, Qian Xue¹, Yingxiao Song¹, Zhenyu Zhang², Xing Li³, Shengxiang Lyu⁴, Qiang Zhan⁵, Fei Liu⁶, Lungen Lu⁷, Liang Zhong⁸, Weixing Chen⁹, Dong Shao¹⁰, Yanbing Ding¹¹, Deliang Liu¹², Xiaozhong Yang¹³, Zhiming Huang¹⁴, Zhaoshen Li¹, Yiqi Du¹

Affiliations

¹ Department of Gastroenterology, Changhai Hospital of Navy Military Medical University, Shanghai 200433, China.
² Department of Gastroenterology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210012, China.
³ Department of Gastroenterology, Pingxiang People's Hospital, Pingxiang, Jiangxi 337055, China.
⁴ Department of Gastroenterology, The First People's Hospital of Lianyungang, Lianyungang, Jiangsu 222061, China.
⁵ Department of Gastroenterology, Wuxi People's Hospital, Wuxi, Jiangsu 214023, China.
⁶ Department of Gastroenterology, Shanghai East Hospital, Shanghai 200120, China.
⁷ Department of Gastroenterology, Shanghai First People's Hospital, Shanghai 200080, China.
⁸ Department of Gastroenterology, Huashan Hospital Affiliated to Fudan University, Shanghai 200000, China.
⁹ Department of Gastroenterology, The First People's Hospital of Yueyang, Yueyang, Hunan 414000, China.
¹⁰ Department of Gastroenterology, The First People's Hospital of Changzhou, Changzhou, Jiangsu 213003, China.
¹¹ Department of Gastroenterology, Yangzhou First People's Hospital, Yangzhou, Jiangsu 225012, China.
¹² Department of Gastroenterology, The Second Xiangya Hospital of Central South University, Changsha, Hunan 410011, China.
¹³ Department of Gastroenterology, Huai'an First People's Hospital, Nanjing Medical University, Huai'an, Jiangsu 223300, China.
¹⁴ Department of Gastroenterology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000, China.

PMID: 39474720
DOI: 10.1097/CM9.0000000000003276

Abstract

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.

Associated data

ClinicalTrials.gov/NCT03615677