Efficacy of moxifloxacin-based sequential therapy for first-line eradication of Helicobacter pylori infection in gastrointestinal disease.

AIM To evaluate the efficacy of 14-d moxifloxacin-based sequential therapy as first-line eradication treatment of Helicobacter pylori (H. pylori) infection. METHODS From December 2013 to August 2014, 161 patients with confirmed H. pylori infection randomly received 14 d of moxifloxacin-based sequential group (MOX-ST group, n = 80) or clarithromycin-based sequential group (CLA-ST group, n = 81) therapy. H. pylori infection was defined on the basis of at least one of the following three tests: a positive (13)C-urea breath test; histologic evidence of H. pylori by modified Giemsa staining; or a positive rapid urease test (CLOtest; Delta West, Bentley, Australia) by gastric mucosal biopsy. Successful eradication therapy for H. pylori infection was defined as a negative (13)C-urea breath test four weeks after the end of eradication treatment. Compliance was defined as good when drug intake was at least 85%. H. pylori eradication rates, patient compliance with drug treatment, adverse event rates, and factors influencing the efficacy of eradication therapy were evaluated. RESULTS The eradication rates by intention-to-treat analysis were 91.3% (73/80; 95%CI: 86.2%-95.4%) in the MOX-ST group and 71.6% (58/81; 95%CI: 65.8%-77.4%) in the CLA-ST group (P = 0.014). The eradication rates by per-protocol analysis were 93.6% (73/78; 95%CI: 89.1%-98.1%) in the MOX-ST group and 75.3% (58/77; 95%CI: 69.4%-81.8%) in the CLA-ST group (P = 0.022). Compliance was 100% in both groups. The adverse event rates were 12.8% (10/78) and 24.6% (19/77) in the MOX-ST and CLA-ST group, respectively (P = 0.038). Most of the adverse events were mild-to-moderate in intensity; there was none serious enough to cause discontinuation of treatment in either group. In multivariate analysis, advanced age (≥ 60 years) was a significant independent factor related to the eradication failure in the CLA-ST group (adjusted OR = 2.13, 95%CI: 1.97-2.29, P = 0.004), whereas there was no significance in the MOX-ST group. CONCLUSION The 14-d moxifloxacin-based sequential therapy is effective. Moreover, it shows excellent patient compliance and safety compared to the 14-d clarithromycin-based sequential therapy.