Efficacy of two levofloxacin-containing second-line therapies for Helicobacter pylori: a pilot study.

BACKGROUND: An ideal second-line therapeutic regimen for the treatment of patients who do not respond to standard triple therapy is currently being investigated. In this study, we aimed to investigate the efficacy of two levofloxacin-containing second-line therapies for Helicobacter pylori (H. pylori).

MATERIALS AND METHODS: One hundred and forty eight consecutive H. pylori -positive patients who did not respond to the standard triple therapy (77 female, 71 male) were enrolled in the study. The patients were randomized consecutively to two-second-line therapy groups; 73 to the levofloxacin-containing sequential (LCS) and 75 to the levofloxacin-containing quadruple (LCQ) therapy group. The LCS therapy group received pantoprazole 40 mg and amoxicillin 1,000 mg twice daily for 5 days followed by pantoprazole 40 mg twice daily and metronidazole 500 mg three times daily and levofloxacin 500 mg one time daily for 7 days. The LCQ therapy group received pantoprazole 40 mg twice daily, tetracycline 500 mg four times daily, bismuth subcitrate 300 mg four times daily and levofloxacin 500 mg one time daily for 10 days. H. pylori eradication was confirmed by stool antigen testing at least 6 weeks after cessation of therapy. Side-effects and compliance were assessed by a questionnaire.

RESULTS: Intention-to-treat cure rates were: 82.2% (95%CI; 73-91) and 90.6% (95%CI; 79-95) in the LCS and LCQ therapy, respectively. Per protocol cure rates were: 85.7% (95%CI; 75-92) and 93.1% (95%CI; 85-98) in the LCS and LCQ therapy, respectively. No statistically significant difference was found between two groups (p = .1). No differences in compliance or adverse effects were demonstrated between two groups.

CONCLUSIONS: This prospective trial demonstrates that both levofloxacin-containing sequential therapy and levofloxacin-containing quadruple therapy regimens have higher H. pylori eradication rates and are well tolerated. The levofloxacin-containing quadruple therapy is likely the best treatment option for a second-line therapy, at least in the Turkish population.