Levofloxacin, bismuth, amoxicillin and esomeprazole as second-line Helicobacter pylori therapy after failure of non-bismuth quadruple therapy.

BACKGROUND

The best rescue therapy for Helicobacter pylori (H. pylori) infection following failure of non-bismuth quadruple therapy (NBQT) remains unanswered.

AIMS: To determine the efficacy, safety and compliance of levofloxacin, bismuth, amoxicillin and esomeprazole (LBAE) regimen following failure of NBQT.

METHODS

132 patients with H. pylori infection refractory to first-line NBQT received LBAE regimen (levofloxacin 500mg once/day, bismuth potassium citrate 220mg twice/day, amoxicillin 1000mg twice/day and esomeprazole 20mg twice/day for 14 days). Gastric mucosal biopsy was obtained for H. pylori culture, antimicrobial sensitivity test and cytochrome P450 isoenzyme 2C19 polymorphism analysis.

RESULTS

LBAE therapy achieved eradication rates of 73.5% [95% confidence intervals (CI) 65.9-81.1%] in intention-to-treat and 78.5% (71.1-85.9%) in per-protocol analyses in patients with high antibiotic resistance (amoxicillin 8.3%, clarithromycin 55.6%, metronidazole 73.6% and levofloxacin 36.1%). Adverse effects were found in 19.2% and compliance in 96.1% of the treated patients. Multivariate analyses identified levofloxacin resistance [odds ratio (OR) 7.183, 95% CI 1.616-31.914, P=0.010] and history of quinolone intake (4.844, 1.174-19.983, P=0.029) as independent predictors of treatment failure. The eradication rate of patients with dual amoxicillin and levofloxacin resistance was significantly decreased (33.3%, P=0.006).

CONCLUSIONS

In populations with high levofloxacin resistance, 14-day second-line LBAE regimen resulted in an unsatisfactory efficacy in patients resistant to NBQT despite good safety and compliance.