Levofloxacin-based triple therapy vs. quadruple therapy in second-line Helicobacter pylori treatment: a randomized trial

Aliment Pharmacol Ther. 2003 Sep 15;18(6):627-33. doi: 10.1046/j.1365-2036.2003.01676.x.

Abstract

Background: Levofloxacin has been shown to be effective in Helicobacter pylori eradication. Two 10-day levofloxacin-based triple therapies were compared with standard 7- and 14-day quadruple regimens in second-line treatment.

Methods: Two hundred and eighty consecutive patients who failed to respond to standard triple therapy (clarithromycin, amoxicillin, rabeprazole) were randomly assigned to four groups: (1) levofloxacin 500 mg o.d., amoxicillin 1 g b.d., rabeprazole 20 mg b.d. for 10 days (LAR, n = 70); (2) levofloxacin 500 mg o.d., tinidazole 500 mg b.d., rabeprazole 20 mg b.d. for 10 days (LTR, n = 70); (3) tetracycline 500 mg q.d.s., metronidazole 500 mg t.d.s., bismuth salt 120 mg q.d.s., rabeprazole 20 mg b.d. for 7 days (7TMBR, n = 70); and (4) for 14 days (14TMBR, n = 70). Helicobacter pylori status and side-effects were assessed 6 weeks after treatment.

Results: The eradication rate was 94% in the LAR group and 90% in the LTR group in both intention-to-treat and per protocol analyses. Helicobacter pylori eradication was achieved in 63 and 69% of the 7TMBR group and in 69 and 80% of the 14TMBR group in intention-to-treat and per protocol analysis, respectively. Side-effects were significantly lower in the LAR and LTR groups than in the 14TMBR group.

Conclusion: Ten-day levofloxacin-based therapies are better than standard quadruple regimens as second-line option for H. pylori eradication.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antacids / administration & dosage
  • Antacids / adverse effects
  • Anti-Infective Agents / administration & dosage*
  • Anti-Infective Agents / adverse effects
  • Bismuth / administration & dosage
  • Bismuth / adverse effects
  • Drug Therapy, Combination / administration & dosage*
  • Drug Therapy, Combination / adverse effects
  • Female
  • Helicobacter Infections / drug therapy*
  • Helicobacter pylori*
  • Humans
  • Levofloxacin*
  • Male
  • Middle Aged
  • Ofloxacin / administration & dosage*
  • Ofloxacin / adverse effects
  • Patient Compliance
  • Prospective Studies
  • Treatment Outcome

Substances

  • Antacids
  • Anti-Infective Agents
  • Levofloxacin
  • Ofloxacin
  • Bismuth