Levofloxacin-based triple therapy in first-line treatment for Helicobacter pylori eradication

Am J Gastroenterol. 2006 Sep;101(9):1985-90. doi: 10.1111/j.1572-0241.2006.00716.x.


Background: The standard first-line therapies for Helicobacter pylori eradication are based on clarithromycin and amoxicillin or metronidazole. Recent studies suggested levofloxacin as an alternative option for both first-and second-line H. pylori eradication treatment.

Aims: To compare efficacy and tolerability of two different 7-day standard triple therapies versus 7-day levofloxacin-based triple therapy in first-line treatment for H. pylori infection.

Methods: Three hundred consecutive H. pylori positive patients were randomized to receive: clarithromycin, amoxicillin, esomeprazole (Group A: N = 100); clarithromycin, metronidazole, esomeprazole (Group B: N = 100); or clarithromycin, levofloxacin, esomeprazole (Group C: N = 100). H. pylori status was rechecked by (13)C urea breath test 6 wk after the end of therapy.

Results: Sixteen out of 300 patients discontinued treatment because of the occurrence of side effects (Group A, 5; Group B, 7; Group C, 4). The eradication rates in intention to treat (ITT) and per protocol (PP) analyses were: Group A, 75% and 79%; Group B, 72% and 77.4%; and Group C, 87% and 90.6%. The eradication rate achieved with levofloxacin-based triple therapy was significantly higher than that with standard therapies in either ITT (87%vs 75%, p <0.05; 87%vs 72%, p <0.01;) or PP analysis (90.6%vs 79%, p <0.05; 90.6 vs 77.4, p <0.05). No difference was found between standard triple therapies. The incidence of side effects was similar among groups.

Conclusions: A 7-day levofloxacin-based triple therapy can achieve higher H. pylori eradication rates than standard regimens. These data suggest levofloxacin-based regimens can be the most effective in first-line anti-H. pylori therapy, at least in the Italian population.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Anti-Bacterial Agents / therapeutic use*
  • Biopsy
  • Clarithromycin / therapeutic use
  • Drug Therapy, Combination
  • Endoscopy, Gastrointestinal
  • Enzyme Inhibitors / therapeutic use
  • Esomeprazole / therapeutic use
  • Female
  • Follow-Up Studies
  • Gastric Mucosa / microbiology
  • Gastric Mucosa / pathology
  • Gastritis / drug therapy*
  • Gastritis / epidemiology
  • Gastritis / microbiology
  • Helicobacter Infections / drug therapy*
  • Helicobacter Infections / epidemiology
  • Helicobacter Infections / microbiology
  • Helicobacter pylori / drug effects
  • Helicobacter pylori / isolation & purification*
  • Humans
  • Levofloxacin*
  • Male
  • Metronidazole / therapeutic use
  • Middle Aged
  • Ofloxacin / therapeutic use*
  • Prospective Studies
  • Treatment Outcome


  • Anti-Bacterial Agents
  • Enzyme Inhibitors
  • Metronidazole
  • Levofloxacin
  • Ofloxacin
  • Clarithromycin
  • Esomeprazole