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

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).