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

Abstract

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.

Keywords: Bismuth; Eradication; Helicobacter pylori; Levofloxacin; Non-bismuth quadruple therapy; Second-line.