Antofloxacin-based bismuth quadruple therapy is safe and effective in Helicobacter pylori eradication: A prospective, open-label, randomized trial.

ABSTRACT

BACKGROUND AND STUDY AIMS: The present study was designed to evaluate the safety, efficacy, and tolerability of antofloxacin-based bismuth quadruple therapy in Chinese patients with Helicobacter pylori infection. PATIENTS AND METHODS: Total 290 patients with H. pylori infection were randomly and equally divided into two groups as per different bismuth quadruple therapies for 14 d colloidal bismuth pectin 200 mg thrice a day, lansoprazole 30 mg twice a day, amoxicillin 1 g twice a day, and antofloxacin 200 mg once a day (ACLA group) or levofloxacin 500 mg once a day (LCLA group). Eradication was assessed with 13C-urea breath test 6 wk after treatment completion; the primary endpoint was the eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses. The minimum inhibitory concentration was measured with the PDM epsilometer test to assess the susceptibility of H. pylori strains on gastric biopsy specimens to antofloxacin and levofloxacin. RESULTS: The eradication rates of H. pylori in the ACLA group were 93.8% and 97.8% for the ITT and PP analysis, respectively; these rates were significantly higher than those in the LCLA group, at 86.2% and 92.6%, respectively (p = 0.031 and 0.041, respectively). The total incidence of adverse events during the eradication therapy did not significantly differ between the ACLA and LCLA groups (31.7% vs. 37.9%%, p = 0.267), and the two groups displayed similar severity of adverse events (p = 0.156) and compliance rate (100% by ACLA vs. 97.8% by LCLA, p = 0.080). The eradication rate with the antofloxacin susceptible strains in the ACLA group was significantly higher than that with the resistant strains (99.2% vs. 66.7%, p = 0.045). Moreover, the eradication rate with the levofloxacin susceptible strains in the LCLA group was significantly higher than that with the resistant strains (95.3% vs. 80.0%, p = 0.013). CONCLUSION: Antofloxacin is safe and effective for H. pylori eradication. Antofloxacin-based bismuth quadruple therapy could be an alternative treatment for H. pylori eradication.