The TOP ‐ GERD Trial: Comparative Efficacy of Tegoprazan Versus Pantoprazole in the Treatment of Erosive Oesophagitis in a Non‐Asian Population

IF 6.8 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Alimentary Pharmacology & Therapeutics Pub Date : 2026-10-04 DOI:10.1111/apt.71032

José M. Remes‐Troche, Luis Raúl Valdovinos‐García, C. Prakash Gyawali, José Luis Vargas‐Basurto, Carlos Alberto Reyes‐Medina, Gisselle Vanessa González‐Hernández, A. Rafael Bernal Mendez, H. H. Barragán Cordova, Pablo Thomas‐Dupont, Peter Grube‐Pagola

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引用次数: 0

Abstract

Background Potassium‐competitive acid blockers provide rapid and sustained acid suppression, but tegoprazan has not been studied in non‐Asian populations. Aim To compare the efficacy and safety of tegoprazan 50 mg once daily with pantoprazole 40 mg once daily for healing erosive oesophagitis and improving reflux symptoms. Methods In this multicentre, randomized, double‐blind, active‐controlled trial, Mexican adults with Los Angeles grade B–D erosive oesophagitis received tegoprazan or pantoprazole for 4 weeks. The primary outcome was superior endoscopic healing at week 4. Secondary outcomes included early symptom response, complete symptom resolution, changes in symptom severity, health‐related quality of life, and adverse events. Results Seventy participants were randomized and 64 completed treatments. In the intention‐to‐treat population, endoscopic healing occurred in 88.9% receiving tegoprazan and 79.4% receiving pantoprazole ( p = 0.33). In the per‐protocol population, healing occurred in 100% and 84.4%, respectively ( p = 0.053). Among participants with Los Angeles grade C or D oesophagitis, per‐protocol healing rates were 100% with tegoprazan and 68.8% with pantoprazole ( p = 0.04). During the first treatment week, at least 50% symptom improvement occurred in 84.4% and 31.3%, respectively ( p < 0.001), and complete symptom resolution was more frequent with tegoprazan from day 1. Symptom severity and health‐related quality of life improved in both groups. Adverse events were infrequent, mild, and unrelated to treatment. Conclusions There was a nonsignificant 9.5% difference in the primary intention‐to‐treat 4‐week healing endpoint between tegoprazan and pantoprazole. Tegoprazan provided faster symptom improvement, while the per‐protocol findings and the higher healing rate observed in the exploratory severe oesophagitis subgroup were encouraging and warrant further investigation. (ClinicalTrials.gov Identifier: NCT06991348).

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TOP - GERD试验：替戈拉赞与泮托拉唑治疗非亚洲人群糜烂性食管炎的比较疗效

背景钾竞争酸阻滞剂提供快速和持续的酸抑制，但替戈拉赞尚未在非亚洲人群中进行研究。目的比较替格拉赞50 mg / d与泮托拉唑40 mg / d治疗糜烂性食管炎及改善反流症状的疗效和安全性。方法在这项多中心、随机、双盲、主动对照试验中，患有洛杉矶B-D级糜烂性食管炎的墨西哥成年人接受替戈拉赞或泮托拉唑治疗4周。第4周的主要结果是内镜下的良好愈合。次要结局包括早期症状反应、症状完全缓解、症状严重程度的改变、健康相关生活质量和不良事件。结果70例随机分组，64例完成治疗。在有意向治疗的人群中，88.9%的患者接受替戈拉赞治疗，79.4%的患者接受泮托拉唑治疗（p = 0.33）。在每个方案人群中，治愈率分别为100%和84.4% （p = 0.053）。在洛杉矶C级或D级食管炎患者中，替戈拉赞和泮托拉唑的方案治愈率分别为100%和68.8% （p = 0.04）。在第一个治疗周，分别有84.4%和31.3%的患者出现至少50%的症状改善（p < 0.001），并且从第1天起，替戈拉散的完全症状缓解更为频繁。两组患者的症状严重程度和健康相关生活质量均有改善。不良事件罕见，轻微，与治疗无关。结论：替戈拉赞和泮托拉唑的4周主要意向治疗终点无显著性差异，差异为9.5%。替戈拉赞提供了更快的症状改善，而在探索性重度食管炎亚组中观察到的按方案结果和更高的治愈率令人鼓舞，值得进一步研究。（ClinicalTrials.gov识别码：NCT06991348）。

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来源期刊

Alimentary Pharmacology & Therapeutics 医学-胃肠肝病学

CiteScore

15.60

自引率

7.90%

发文量

527

审稿时长

3-6 weeks

期刊介绍： Alimentary Pharmacology & Therapeutics is a global pharmacology journal focused on the impact of drugs on the human gastrointestinal and hepato-biliary systems. It covers a diverse range of topics, often with immediate clinical relevance to its readership.