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
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
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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).
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).