Introduction
Helicobacter pylori infection remains a major global health burden, and eradication rates with empirical regimens frequently fail to achieve optimal (>90%) effectiveness. Potassium-competitive acid blockers may enhance antibiotic efficacy through sustained acid suppression. We evaluated the effectiveness and safety of an optimized dual regimen with tegoprazan and high-dose amoxicillin in routine clinical practice.
Aims & Methods
Prospective quasi-experimental real-world pilot study including adults diagnosed with H. pylori infection by histology during upper gastrointestinal endoscopy. Patients received tegoprazan 50 mg three times daily combined with optimized weight-based amoxicillin (50 mg/kg/day divided into four doses) for 14 days. Eradication was assessed using 13C-urea breath test 4 weeks after treatment. The primary outcome was eradication rate by intention-to-treat analysis. Safety outcomes included overall adverse events.
Results
Twenty-eight patients were included (mean age 52 ± 14 years; 71% female). Overall eradication rate was 96.4% (27/28; 95% CI 81.7–99.9), significantly higher than the historical benchmark of 85% (p < 0.001). Mild adverse events occurred in 14.3% (95% CI 4.0–32.7), mainly headache (7.1%), diarrhea (3.6%) and abdominal distension (3.6%). No serious adverse events or treatment discontinuations were observed.
Table. Outcomes of optimized dual therapy with tegoprazan and amoxicillin (n = 28)
| Variable | Result | Effect estimate | 95% CI | p value |
|---|
| Age, mean ± SD (years) | 52 ± 14 | — | — | — |
| Female sex, n (%) | 20 (71.4%) | — | 51.3–86.8 | — |
| Dyspepsia indication, n (%) | 18 (64.3%) | — | 44.1–80.7 | — |
| GERD symptoms, n (%) | 10 (35.7%) | — | 19.3–55.9 | — |
| Eradication rate (ITT), n (%) | 27 (96.4%) | — | 81.7–99.9 | <0.001* |
| Adverse events overall, n (%) | 4 (14.3%) | — | 4.0–32.7 | 0.12 |
| Headache, n (%) | 2 (7.1%) | — | 0.9–23.5 | — |
| Diarrhea, n (%) | 1 (3.6%) | — | 0.1–18.3 | — |
| Abdominal distension, n (%) | 1 (3.6%) | — | 0.1–18.3 | — |
Conclusion
An optimized dual regimen using tegoprazan three times daily with high-dose amoxicillin achieved excellent eradication rates and favourable tolerability in real-world conditions. This simplified strategy may represent an effective alternative to conventional multi-drug regimens. Larger controlled studies are warranted to confirm these findings.
References
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