title: 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.
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.
  
  
  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.
  
  
  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.
authors.affiliation: Gastroenterology and Hepatology Department, Athens Medical, P. Faliron General Hospital, Athens, Greece.
authors.forename: Sotirios D
authors.initials: SD
authors.lastname: Georgopoulos
authors.forename: Elias
authors.initials: E
authors.lastname: Xirouchakis
authors.forename: Beatriz
authors.initials: B
authors.lastname: Martinez-Gonzalez
authors.forename: Dionyssios N
authors.initials: DN
authors.lastname: Sgouras
authors.forename: Charikleia
authors.initials: C
authors.lastname: Spiliadi
authors.forename: Andreas F
authors.initials: AF
authors.lastname: Mentis
authors.forename: Fotini
authors.initials: F
authors.lastname: Laoudi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000658:Amoxicillin / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D017291:Clarithromycin / Q000627:therapeutic use*; D024881:Drug Resistance, Bacterial; D004359:Drug Therapy, Combination; D064098:Esomeprazole / Q000627:therapeutic use*; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects* / Q000502:physiology; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use*; D008875:Middle Aged; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D008795:Metronidazole; D000658:Amoxicillin; D017291:Clarithromycin; D064098:Esomeprazole
keywords: H. pylori treatment; clarithromycin resistance; concomitant therapy; dual resistance; first line; second line