Therapeutic advances in gastroenterology · 2025
Comparative efficacy and safety of vonoprazan versus esomeprazole-based high-dose dual therapies for first-line Helicobacter pylori eradication: a randomized controlled trial.
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Tai Wei-Chen, Lu Lung-Sheng, Yang Shih-Cheng, Wang Hsin-Ming, Wu Cheng-Kun, Yao Chih-Chien, Huang Pao-Yuan, Lee Yu-Chi, Chuah Seng-Kee, Liang Chih-Ming
Аннотация
BACKGROUND: Effective Helicobacter pylori (H. pylori) eradication depends on maintaining intragastric pH >6 and overcoming antibiotic resistance. High-dose dual therapy (HDDT) with a proton pump inhibitor (PPI) and amoxicillin has shown promising results.
OBJECTIVES: To compare the efficacy of 14-day vonoprazan-based (VA) and esomeprazole-based (EA) HDDT for H. pylori eradication and evaluate the impact of antibiotic resistance.
DESIGN: Randomized controlled trial (RCT).
METHODS: A total of 121 patients with confirmed H. pylori infection were randomized to receive either VA therapy (vonoprazan 20 mg twice daily plus amoxicillin 750 mg four times daily (QID)) or EA therapy (esomeprazole 40 mg three times daily plus amoxicillin 750 mg QID) for 14 days. Eradication was assessed by the ¹³C-urea breath test at week 8. Antibiotic susceptibility testing was performed on cultured isolates.
RESULTS: Baseline demographic and clinical characteristics were comparable between the VA and EA groups. In the intention-to-treat analysis, eradication rates were 86.9% (95% confidence interval (CI): 78.4%-95.4%) in the VA group and 81.7% (95% CI: 71.3%-89.4%) in the EA group (p = 0.430). Per-protocol (PP) analysis showed eradication rates of 93.0% (95% CI: 86.4%-99.6%) for VA and 84.5% (95% CI: 73.8%-92.1%) for EA (p = 0.150), indicating no statistically significant difference. Adverse events (AEs) were mild and similar between groups (5.3% in VA vs 5.2% in EA, p = 0.983), with constipation and diarrhea being the most reported. Both groups achieved 100% compliance. Antibiotic resistance patterns did not significantly affect outcomes.
CONCLUSION: Both VA and EA-HDDT regimens demonstrated comparable efficacy, excellent compliance, and minimal AEs. Although VA therapy achieved a >90% eradication rate in the PP analysis, our study was underpowered to confirm superiority. Therefore, larger, adequately powered RCTs are warranted to validate the potential superiority of VA.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT06811207.
OBJECTIVES: To compare the efficacy of 14-day vonoprazan-based (VA) and esomeprazole-based (EA) HDDT for H. pylori eradication and evaluate the impact of antibiotic resistance.
DESIGN: Randomized controlled trial (RCT).
METHODS: A total of 121 patients with confirmed H. pylori infection were randomized to receive either VA therapy (vonoprazan 20 mg twice daily plus amoxicillin 750 mg four times daily (QID)) or EA therapy (esomeprazole 40 mg three times daily plus amoxicillin 750 mg QID) for 14 days. Eradication was assessed by the ¹³C-urea breath test at week 8. Antibiotic susceptibility testing was performed on cultured isolates.
RESULTS: Baseline demographic and clinical characteristics were comparable between the VA and EA groups. In the intention-to-treat analysis, eradication rates were 86.9% (95% confidence interval (CI): 78.4%-95.4%) in the VA group and 81.7% (95% CI: 71.3%-89.4%) in the EA group (p = 0.430). Per-protocol (PP) analysis showed eradication rates of 93.0% (95% CI: 86.4%-99.6%) for VA and 84.5% (95% CI: 73.8%-92.1%) for EA (p = 0.150), indicating no statistically significant difference. Adverse events (AEs) were mild and similar between groups (5.3% in VA vs 5.2% in EA, p = 0.983), with constipation and diarrhea being the most reported. Both groups achieved 100% compliance. Antibiotic resistance patterns did not significantly affect outcomes.
CONCLUSION: Both VA and EA-HDDT regimens demonstrated comparable efficacy, excellent compliance, and minimal AEs. Although VA therapy achieved a >90% eradication rate in the PP analysis, our study was underpowered to confirm superiority. Therefore, larger, adequately powered RCTs are warranted to validate the potential superiority of VA.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT06811207.