Short-Term Efficacy of Tegoprazan Compared With Esomeprazole in Patients With Non-Erosive Reflux Disease and Nocturnal Heartburn Symptoms: A Double-Blind, Randomized Controlled Trial.

OBJECTIVES: Tegoprazan is a novel potassium-competitive acid blocker that rapidly suppresses acid secretion. This study aimed to evaluate the efficacy of tegoprazan 50 mg compared with esomeprazole 20 mg in patients with non-erosive reflux disease and nocturnal heartburn symptoms. METHODS: This double-blind, randomized, active-control study was conducted to compare the efficacy of tegoprazan 50 mg and esomeprazole 20 mg in patients with non-erosive reflux disease and nocturnal heartburn symptoms. The primary endpoint was the percentage of nocturnal heartburn-free days over 2 weeks. The secondary endpoint was the percentage of patients who experienced relief from nocturnal heartburn within 24 h of the first dose. Additionally, the time to the first nocturnal heartburn-free interval was compared between the two groups. RESULTS: Of 160 patients, 149 were included in the final analysis. The percentage of nocturnal heartburn-free days over 2 weeks was not inferior to that with esomeprazole (58.2% vs. 54.5%, p=0.001). The percentage of patients without nocturnal heartburn for 24 h was higher in the tegoprazan group, although the difference was not statistically significant. The time to the first nocturnal heartburn-free interval was shorter with tegoprazan than with esomeprazole (2.0 days vs. 2.5 days, p=0.529); however, the difference was not significant. CONCLUSIONS: Tegoprazan demonstrated non-inferiority to esomeprazole with respect to nocturnal heartburn-free days and may provide more rapid relief from nocturnal heartburn symptoms.