A study of 4- and 7-day triple therapy with rabeprazole, high-dose levofloxacin and tinidazole rescue treatment for Helicobacter pylori eradication

Aliment Pharmacol Ther. 2006 Jan 15;23(2):281-7. doi: 10.1111/j.1365-2036.2006.02756.x.

Abstract

Background: Helicobacter pylori treatment failure is becoming an emergent problem in clinical practice. Shorter treatment duration should improve compliance to therapy and keep an acceptable H. pylori eradication rate.

Aims: To evaluate the efficacy of two rabeprazole, high-dose levofloxacin and tinidazole-based regimens as 'rescue' treatment for H. pylori eradication in an open-label, randomized, pilot study carried out in a clinical practice setting.

Methods: Eighty-five consecutive patients who have previously failed at least one H. pylori eradication attempt were randomized to receive rabeprazole (20 mg, b.d.), levofloxacin (500 mg, b.d.) and tinidazole (500 mg, b.d.) either for 4 (4-day RLT, n = 42) or 7 days (7-day RLT, n = 43). Cure of H. pylori infection was assessed by means of 13C-urea breath test.

Results: The 7-day RLT achieved 84% (95% CI: 69-93%) and 86% (95% CI: 72-95%) eradication rates in intention-to-treat and per-protocol analyses respectively. The shorter treatment obtained an 83% (95% CI: 69-93%) eradication rate in both intention-to-treat and per-protocol analysis. Both regimens were well tolerated, although patients who received the 4-day RLT reported fewer side-effects.

Conclusions: In patients who have previously failed at least one H. pylori eradication attempt, both 4- and 7-day rabeprazole, high-dose levofloxacin, tinidazole-based regimens are effective in curing the infection in more than 80% of patients.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / adverse effects
  • Anti-Infective Agents / administration & dosage*
  • Anti-Infective Agents / adverse effects
  • Antitrichomonal Agents / administration & dosage
  • Antitrichomonal Agents / adverse effects
  • Benzimidazoles / administration & dosage*
  • Benzimidazoles / adverse effects
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Enzyme Inhibitors / administration & dosage
  • Enzyme Inhibitors / adverse effects
  • Female
  • Helicobacter Infections / drug therapy*
  • Helicobacter pylori / drug effects*
  • Humans
  • Levofloxacin*
  • Male
  • Middle Aged
  • Ofloxacin / administration & dosage*
  • Ofloxacin / adverse effects
  • Omeprazole / administration & dosage
  • Omeprazole / adverse effects
  • Omeprazole / analogs & derivatives*
  • Pilot Projects
  • Rabeprazole
  • Time Factors
  • Tinidazole / administration & dosage*
  • Tinidazole / adverse effects
  • Treatment Outcome

Substances

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Anti-Bacterial Agents
  • Anti-Infective Agents
  • Antitrichomonal Agents
  • Benzimidazoles
  • Enzyme Inhibitors
  • Tinidazole
  • Rabeprazole
  • Levofloxacin
  • Ofloxacin
  • Omeprazole