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Clinical Evaluation of a Ten-Day Regimen with Esomeprazole, Metronidazole, Amoxicillin, and Clarithromycin for the Eradication of Helicobacter pylori in a High Clarithromycin Resistance Area
Background
Increasing clarithromycin resistance reduces Helicobacter pylori eradication rates with conventional triple regimens. We evaluated effectiveness and safety of a 10‐day‐quadruple nonbismuth containing regimen, as first‐line treatment or second‐line treatment (after conventional triple) for H. pylori, and assessed impact of antibiotic resistance on treatment success.
Materials and methods
Eligible patients had upper GI endoscopy and positive CLO‐test, also confirmed by histology and/or culture. The eradication scheme comprised: Esomeprazole 40 mg, Metronidazole 500 mg, Amoxicillin 1000 mg, and Clarithromycin 500 mg, twice daily, for 10 days. Treatment adherence and adverse effects were recorded. Eradication was tested by 13C‐urea breath test or histology.
Results
One hundred and ninety out of 198 patients (115M/83F, aged 18–81, mean 52 years, 37% smokers, 27% ulcer disease) who completed the study protocol were evaluated for eradication. Adherence to treatment was 97.7% (95% CI 95.9–99.6). Six (3.2%) patients experienced severe side effects and discontinued treatment. Intention to treat and per protocol analysis in first line was 91.5% (95% CI 86.2–94.8) and 95% (95% CI 90.4–97.4) and in second line was 60.6% (95% CI 43.6–75.3) and 64.5% (95% CI 46.9–78.8), respectively. Antibiotic susceptibility tests were performed in 106 of 124 (85%) patients who gave consent. Among them 42 (40%) harbored clarithromycin resistant strains. Eradication rates were significantly higher in sensitive and single clarithromycin or metronidazole resistant (37/37, 100% and 43/47, 91%) than in dual resistant strains (12/22, 55%) (p < .0001). Specifically, concomitant regimen eradicated 7/10, 70% of dual resistant strains as first‐line treatment and 5/12, 42% as second‐line treatment. Multivariate analysis showed that dual resistance was the only independent significant predictor of treatment failure.
Conclusions
The 10‐days “concomitant” regimen is effective and safe first‐line H. pylori treatment, in a high clarithromycin resistance area, although dual antibiotic resistance may compromise its effectiveness.