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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.
- Source :
-
Helicobacter [Helicobacter] 2013 Dec; Vol. 18 (6), pp. 459-67. Date of Electronic Publication: 2013 May 29. - Publication Year :
- 2013
-
Abstract
- 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.<br />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 (13) C-urea breath test or histology.<br />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.<br />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.<br /> (© 2013 John Wiley & Sons Ltd.)
- Subjects :
- Adult
Aged
Aged, 80 and over
Drug Therapy, Combination
Female
Helicobacter Infections microbiology
Helicobacter pylori physiology
Humans
Male
Middle Aged
Prospective Studies
Young Adult
Amoxicillin therapeutic use
Anti-Bacterial Agents therapeutic use
Clarithromycin therapeutic use
Drug Resistance, Bacterial
Esomeprazole therapeutic use
Helicobacter Infections drug therapy
Helicobacter pylori drug effects
Metronidazole therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1523-5378
- Volume :
- 18
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Helicobacter
- Publication Type :
- Academic Journal
- Accession number :
- 23714140
- Full Text :
- https://doi.org/10.1111/hel.12062