Shin Cheol Min, Choi Suck Chei, Cho Jin Woong, Kim Seung Young, Lee Ok Jae, Kim Do Hoon, Cho Yu Kyung, Lee Ju Yup, Lee Sang Kil, Shin Jeong Eun, Kim Gwang Ha, Park Seon-Young, Hong Su Jin, Jung Hye-Kyung, Lee Sang Jin, Youn Young Hoon, Jeon Seong Woo, Sung In Kyung, Park Moo In, Lee Oh Young
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Department of Gastroenterology, School of Medicine, Wonkwang University, Iksan, Korea.
Neurogastroenterol Motil. 2025 Jan;37(1):e14969. doi: 10.1111/nmo.14969. Epub 2024 Nov 25.
The aims of this study were to confirm the non-inferiority of tegoprazan to lansoprazole up to week 4 in patients with erosive esophagitis (EE) and to evaluate its effectiveness in rapid mucosal healing and symptom relief at week 2.
In this multi-center, randomized, double-blind, active-comparator non-inferiority trial, 218 patients with endoscopically confirmed EE (Los Angeles Classification Grades A-D) were randomly allocated to either the tegoprazan (50 mg) or lansoprazole (30 mg) group. The primary endpoint was the cumulative proportion of patients with healed EE up to week 4, as confirmed through endoscopy. The proportion of patients with healed EE at week 2 was also evaluated. Furthermore, CYP2C19 genotypes, symptoms, safety, and tolerability were assessed.
In the full-analysis set, 103 and 109 participants in the tegoprazan and lansoprazole groups, respectively, were analyzed. The cumulative healing rates up to week 4 were 95.2% (98/103) and 86.2% (94/109) (difference [95% confidence interval], 8.91 [1.22-16.59]; p < 0.0001 for non-inferiority and 0.0266 for superiority), while those at week 2 were 88.4% (91/103) and 82.6% (90/109) (5.78 [-3.66-15.22], p = 0.0005 for non-inferiority) for tegoprazan and lansoprazole, respectively. Tegoprazan showed consistent healing rates regardless of CYP2C19 genotypes.
Tegoprazan was superior to lansoprazole in the treatment of EE up to 4 weeks. Further studies are necessary to confirm these findings and clarify the superiority of tegoprazan, especially in the treatment of severe EE.
ClinicalTrials.gov identifier: NCT05267743.
本研究旨在证实替戈拉赞在治疗糜烂性食管炎（EE）患者至第4周时不劣于兰索拉唑，并评估其在第2周时促进黏膜快速愈合和缓解症状的有效性。
在这项多中心、随机、双盲、活性对照非劣效性试验中，218例经内镜确诊为EE（洛杉矶分级A - D级）的患者被随机分配至替戈拉赞（50mg）组或兰索拉唑（30mg）组。主要终点是至第4周时经内镜确认的EE愈合患者的累积比例。还评估了第2周时EE愈合患者的比例。此外，对CYP2C19基因型、症状、安全性和耐受性进行了评估。
在全分析集里，分别对替戈拉赞组的103名参与者和兰索拉唑组的109名参与者进行了分析。至第4周时的累积愈合率分别为95.2%（98/103）和86.2%（94/109）（差异[95%置信区间]，8.91[1.22 - 16.59]；非劣效性p < 0.0001，优效性p = 0.0266），而替戈拉赞和兰索拉唑在第2周时的累积愈合率分别为88.4%（91/103）和82.6%（90/109）（5.78[-3.66 - 15.22]，非劣效性p = 0.0005）。无论CYP2C19基因型如何，替戈拉赞均显示出一致的愈合率。
在治疗EE至4周时，替戈拉赞优于兰索拉唑。有必要进行进一步研究以证实这些发现，并阐明替戈拉赞的优越性，尤其是在治疗重度EE方面。
ClinicalTrials.gov标识符：NCT05267743。
