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Second-line treatment for Helicobacter pylori eradication after sequential therapy failure: a pilot study

Angelo Zullo, Vincenzo De Francesco, Cesare Hassan, Carmine Panella, Sergio Morini and Enzo Ierardi

Background: Helicobacter pylori plays a role in peptic ulcer and gastric carcinogenesis. It has been found that the success rate following standard 7-day triple therapies is decreasing. We have recently proposed a more successful 10-day sequential regimen as first-line therapy. However, no data are currently available for a rescue treatment in the event of eradication failure. Objective: We designed the present study in order to evaluate the efficacy of a levofloxacin–amoxycillin-based regimen as second-line therapy in sequential therapy-failure patients. Methods: This was a prospective, open-label, pilot study enrolling patients who failed H. pylori eradication after sequential therapy. Patients received a 10-day triple therapy comprising rabeprazole 20 mg twice a day, levofloxacin 250 mg twice a day and amoxycillin 1 g twice a day. Bacterial eradication was examined 4–6 weeks after treatment by using a ¹³C urea breath test. Results: Overall, 35 patients were enrolled (Males: 20; mean age: 49 ± 12 years), 29 with nonulcer dyspepsia and six with peptic ulcer. H. pylori infection was successfully cured in 30 patients, accounting for a 85.7% (95% confidence interval [CI]: 74–97) and 88.2% (95% CI: 77–99) eradication rates at intention-totreat and per protocol analyses, respectively. One patient stopped the treatment earlier due to side effects. Conclusions: Data showed that levofloxacin–amoxycillin triple therapy is a successful second-line treatment for sequential therapy-failure patients. Therefore, the 10-day sequential regimen plus the 10-day levofloxacin-based triple therapy may represent a valid therapeutic package for H. pylori managment in clinical practice.