title: The efficacy of second-line anti-Helicobacter pylori therapy using an extended 14-day levofloxacin/amoxicillin/proton-pump inhibitor treatment--a pilot study.
abstract: BACKGROUND
  Large meta-analyses of second-line Helicobacter pylori eradication with fluoroquinolone triple therapy have shown that neither 7-day nor 10-day therapy provides 90% or better treatment success. Reports describing second-line H. pylori eradication using 14-day fluoroquinolone-containing triple therapy are few. Current study aimed to determine the efficacy of a 14-day levofloxacin/amoxicillin/proton-pump inhibitor regimen as second-line therapy and the clinical factors influencing the outcome.
  
  
  METHODS
  One-hundred and one patients who failed H. pylori eradication using the standard triple therapy for 7 days were randomly assigned to either a levofloxacin/amoxicillin/esomeprazole group (levofloxacin 500 mg once daily, amoxicillin 1 g twice daily, and esomeprazole 40 mg twice daily for 14 days) or a esomeprazole/metronidazole/bismuth salt/tetracycline group (esomeprazole 40 mg twice daily, metronidazole 250 mg four times daily, tripotassium dicitrate bismuthate 300 mg four times daily, and tetracycline 500 mg four times daily for 14 days). Follow-up to assess treatment response consisted of either endoscopy or a urea breath test, which were carried out 8 weeks later.
  
  
  RESULTS
  Eradication rates attained by levofloxacin/amoxicillin/esomeprazole and esomeprazole/metronidazole/bismuth salt/tetracycline treatments in the per-protocol analysis were 44/47 (93.6%; 95% CI = 86-99.8) and 43/47 (91.8%; 95% CI = 83.2-98.5). In the intention-to-treat analysis, these were 43/47 (86.3%; 95% CI = 76.5-96.1) in the LAE group (four lost to follow-up) and 43/50 (86%; 95% CI = 76-96) in the EMBT groups. The observed adverse events were 25.5% and 38.5% among the two groups. There was 100% drug compliance among the levofloxacin/amoxicillin/esomeprazole group. Levofloxacin-resistant strains occurred at a frequency of 32.3%. H. pylori eradication rates for the levofloxacin-susceptible strains and levofloxacin-resistant strains were 92% (11/12) and 33% (1/3) in the per-protocol analysis.
  
  
  CONCLUSIONS
  A 14-day levofloxacin/amoxicillin/esomeprazole triple therapy approach provides a >90% per-protocol report card with the caveat that this approach is markedly less effective in the presence of fluoroquinolone resistance. Levofloxacin-resistant strains are increasing in Taiwan.
authors.affiliation: Division of Hepatogastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan. chuahsk@seed.net.tw
authors.forename: Seng-Kee
authors.initials: SK
authors.lastname: Chuah
authors.forename: Wei-Chen
authors.initials: WC
authors.lastname: Tai
authors.forename: Pin-I
authors.initials: PI
authors.lastname: Hsu
authors.forename: Deng-Chyang
authors.initials: DC
authors.lastname: Wu
authors.forename: Keng-Liang
authors.initials: KL
authors.lastname: Wu
authors.forename: Chung-Mou
authors.initials: CM
authors.lastname: Kuo
authors.forename: Yi-Chun
authors.initials: YC
authors.lastname: Chiu
authors.forename: Ming-Luen
authors.initials: ML
authors.lastname: Hu
authors.forename: Yeh-Pin
authors.initials: YP
authors.lastname: Chou
authors.forename: Yuan-Hung
authors.initials: YH
authors.lastname: Kuo
authors.forename: Chih-Ming
authors.initials: CM
authors.lastname: Liang
authors.forename: King-Wah
authors.initials: KW
authors.lastname: Chiu
authors.forename: Tsung-Hui
authors.initials: TH
authors.lastname: Hu
mesh_terms: D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001944:Breath Tests; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000008:administration & dosage*; D010865:Pilot Projects; D054328:Proton Pump Inhibitors / Q000008:administration & dosage*; D013624:Taiwan; D013997:Time Factors; D016896:Treatment Outcome; D014508:Urea / Q000032:analysis
chemical_list: D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D064704:Levofloxacin; D000658:Amoxicillin; D014508:Urea; D015242:Ofloxacin