Comparative Efficacy of Potassium-Competitive Acid Blocker-Based Triple Therapy with Tegoprazan versus Vonoprazan for Helicobacter pylori Eradication: A Randomized, Double-Blind, Active-Controlled Pilot Study

Abstract

Background/aims: Triple therapy with vonoprazan, a potassium-competitive acid blocker, has shown an acceptable eradication rate. The aim of this study was to evaluate the efficacy and safety of tegoprazan-based triple therapy compared with those of vonoprazan-based triple therapy for Helicobacter pylori eradication.

Methods: This randomized, double-blind, active-controlled, multicenter pilot study included treatment-naive adults with H. pylori infection. Participants were randomized 1:1:1 to receive tegoprazan 50 mg (TAC 1), tegoprazan 100 mg (TAC 2), or vonoprazan 20 mg (VAC) with amoxicillin 1,000 mg plus clarithromycin 500 mg twice daily for 10 days. The primary outcome was the eradication rate.

Results: Of the 102 enrolled participants, 97 completed the study. The eradication rates in the full analysis set were 60.61% (95% confidence interval [CI], 43.93% to 77.28%), 78.79% (95% CI, 64.84% to 92.74%), and 84.85% (95% CI, 72.62% to 97.08%) in TAC 1, TAC 2, and VAC, respectively. The eradication rates in the per-protocol set were 66.67% (95% CI, 49.80% to 83.54%), 86.67% (95% CI, 74.50% to 98.83%), and 87.50% (95% CI, 76.04% to 98.96%) in TAC 1, TAC 2, and VAC, respectively. In the full analysis set, the eradication rate differences were -6.06% (95% CI, -24.61% to 12.49%) between TAC 2 and VAC and -24.24% (95% CI, -44.92% to -3.56%) between TAC 1 and VAC. In the per-protocol set, the eradication rate differences were -0.83% (95% CI, -19.97% to 17.37%) between TAC 2 and VAC and -20.83% (95% CI, -41.23% to -0.44%) between TAC 1 and VAC. All therapies were well tolerated with no notable safety differences.

Conclusions: After 10 days, tegoprazan 100 mg showed eradication rates comparable to those of vonoprazan 20 mg, while 50 mg may be insufficient. These findings support future research to optimize tegoprazan dosing in clinical practice (ClinicalTrials.gov; NCT04128917).

Keywords: Antibiotics; Clinical trials; Helicobacter pylori; randomized.

Fig. 1

Flow diagram showing the study protocol.

Fig. 2

Study enrollment and treatment allocation after randomization. TAC 1 refers to triple therapy with tegoprazan 50 mg twice daily, TAC 2 to triple therapy with tegoprazan 100 mg twice daily, and VAC to triple therapy with vonoprazan 20 mg twice daily. Each regimen was administered with amoxicillin 1,000 mg and clarithromycin 500 mg, both taken orally twice daily after meals for 10 days. The full analysis set included all randomized participants who did not violate the inclusion/exclusion criteria and received at least one dose of the study drug. Participants were considered noncompliant and excluded from the per-protocol set if the medication compliance rate was <80% within a treatment window of “Day 11+3” based on the assessment conducted at Visit 3. The per-protocol set was defined as all participants in the full analysis set (FAS) except those who were prematurely withdrawn from the study, did not complete all major endpoints, were not treated with the randomized study drugs, received prohibited drugs prior to the primary efficacy endpoint assessment (Visit 4), exhibited noncompliance (<80% within a treatment window of “Day 11+3” based on the assessment conducted at Visit 3), or had other major protocol deviations/violations. A participant whose efficacy endpoint data (assessment of Helicobacter pylori eradication) was missing was handled as an eradication failure in the FAS analyses.

Fig. 3

Efficacy assessment. Helicobacter pylori eradication rates for each regimen in both the FAS and PPS are shown on the left. The differences in eradication rates between the tegoprazan groups (50 mg and 100 mg) and the vonoprazan 20 mg group are displayed on the right. Error bars denote 95% confidence intervals. FAS, full analysis set; PPS, per-protocol set.