Alimentary pharmacology & therapeutics · 2026
The TOP-GERD Trial: Comparative Efficacy of Tegoprazan Versus Pantoprazole in the Treatment of Erosive Oesophagitis in a Non-Asian Population.
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Remes-Troche José M, Valdovinos-García Luis Raúl, Gyawali C Prakash, Vargas-Basurto José Luis, Reyes-Medina Carlos Alberto, González-Hernández Gisselle Vanessa, Mendez A Rafael Bernal, Cordova H H Barragán, Thomas-Dupont Pablo, Grube-Pagola Peter
Аннотация
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).
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).