Comparison of Tegoprazan and Lansoprazole in Patients With Erosive Esophagitis up to 4 Weeks: A Multi-Center, Randomized, Double-Blind, Active-Comparator Phase 4 Trial

Abstract

Background: The aims of this study were to confirm the non-inferiority of tegoprazan to lansoprazole up to week 4 in patients with erosive esophagitis (EE) and to evaluate its effectiveness in rapid mucosal healing and symptom relief at week 2.

Methods: In this multi-center, randomized, double-blind, active-comparator non-inferiority trial, 218 patients with endoscopically confirmed EE (Los Angeles Classification Grades A-D) were randomly allocated to either the tegoprazan (50 mg) or lansoprazole (30 mg) group. The primary endpoint was the cumulative proportion of patients with healed EE up to week 4, as confirmed through endoscopy. The proportion of patients with healed EE at week 2 was also evaluated. Furthermore, CYP2C19 genotypes, symptoms, safety, and tolerability were assessed.

Key results: In the full-analysis set, 103 and 109 participants in the tegoprazan and lansoprazole groups, respectively, were analyzed. The cumulative healing rates up to week 4 were 95.2% (98/103) and 86.2% (94/109) (difference [95% confidence interval], 8.91 [1.22-16.59]; p < 0.0001 for non-inferiority and 0.0266 for superiority), while those at week 2 were 88.4% (91/103) and 82.6% (90/109) (5.78 [-3.66-15.22], p = 0.0005 for non-inferiority) for tegoprazan and lansoprazole, respectively. Tegoprazan showed consistent healing rates regardless of CYP2C19 genotypes.

Conclusions and inferences: Tegoprazan was superior to lansoprazole in the treatment of EE up to 4 weeks. Further studies are necessary to confirm these findings and clarify the superiority of tegoprazan, especially in the treatment of severe EE.

Trial registration: ClinicalTrials.gov identifier: NCT05267743.

Keywords: erosive esophagitis; lansoprazole; potassium competitive acid blocker; proton pump inhibitor; tegoprazan.

FIGURE 1

Randomization protocol and patient dispositions.

FIGURE 2

Subgroup analysis of mucosal healing rates up to week 4 (A–C) and at week 2 (D–F, full‐analysis set). Comparing mucosal healing rates by CYP2C19 genotypes (A, D) and the severity of esophagitis (Los Angeles grade; B, E) in each treatment group, and comparing mucosal healing rates by treatment group (C, F) based on the severity of esophagitis. p‐values were calculated using the unpaired t‐test. EM, extensive metabolizer; IM, intermediate metabolizer; PM, poor metabolizer.

FIGURE 3

Proportion of days without heartburn calculated daily (A) and daily proportions of patients without heartburn (B) during the first 2 weeks after drug administration in the tegoprazan and lansoprazole groups.