The Effect of Tegoprazan on Serum Gastrin Levels and the Development of Hypergastrinemia in the Maintenance Treatment for Gastroesophageal Reflux Disease: Comparison to Lansoprazole.

Background/Aims: Safety data on potassium-competitive acid blockers are limited. We aim to evaluate the effect of tegoprazan on serum gastrin levels during maintenance treatment for gastroesophageal reflux disease compared to lansoprazole. Methods: In a prospective, randomized trial, patients who underwent initial treatment with a standard dose of a proton pump inhibitor (n = 121) or tegoprazan (n = 226) were randomized to receive a half-dose of tegoprazan (n = 173) or lansoprazole (n = 174) as maintenance treatment for up to 24 weeks. Serum gastrin levels were measured immediately after initial treatment and monitored throughout the maintenance treatment period. Results: Baseline gastrin levels were similar between the tegoprazan and lansoprazole groups (P = 0.335). During maintenance treatment, gastrin levels were significantly lower in the tegoprazan group at week 16 (P = 0.001) and week 24 (P = 0.012) compared to the lansoprazole group. Although the proportion of hypergastrinemia (> 115 pg/mL) was similar at baseline between the tegoprazan and lansoprazole groups (P = 0.114), it was significantly lower in the tegoprazan group during maintenance treatment (P = 0.003, 0.033, and 0.039 at weeks 8, 16, and 24, respectively) than in the lansoprazole group. Multivariate analysis revealed that age, sex, baseline gastrin levels, Helicobacter pylori infection, and the drug group were independently associated with final gastrin levels. Conclusion: Tegoprazan has a smaller impact on increasing serum gastrin levels and the development of hypergastrinemia than lansoprazole, suggesting that tegoprazan may reduce safety concerns related to hypergastrinemia, particularly at half doses.