Efficacy of levofloxacin-based rescue therapy for Helicobacter pylori infection after standard triple therapy: a randomized controlled trial.

OBJECTIVES This prospective study was designed to determine the efficacy of a levofloxacin-based rescue therapy for Helicobacter pylori infection after failure of standard triple therapies. We also surveyed the predictors of this rescue therapy. PATIENTS AND METHODS From June 2005 to March 2007, 1036 patients infected with H. pylori received standard triple regimens (proton pump inhibitor, clarithromycin and amoxicillin). H. pylori eradication was achieved in 855 (82.5%) subjects. One hundred and sixty-six eradication-failure patients were enrolled and randomly assigned to receive a 7 day eradication therapy with esomeprazole, bismuth subcitrate, tetracycline and metronidazole (EBTM) or esomeprazole, amoxicillin and levofloxacin (EAL). Follow-up endoscopy was done 16 weeks later to assess the treatment response. Patients' response, CYP2C19 genotypes and antibiotic resistances were also examined. RESULTS Intention-to-treat analysis revealed that both groups showed similar eradication rates [EBTM 63.9%; 95% confidence interval (CI): 53.6-74.2 and EAL 69.9%; 95% CI: 60.1-79.7] (P = 0.89). Per-protocol results were EBTM = 84.1% (95% CI: 75.1-93.1) and EAL = 75.3% (95% CI: 65.8-84.8) (P = 0.82). Both regimens had similar compliance (P = 0.32), but the EBTM group had more adverse events (P = 0.27). Logistic regression analysis showed that poor compliance, CYP2C19 homozygous extensive metabolizer genotype and levofloxacin resistance were important predictors for eradication failure. CONCLUSIONS The EAL regimen can achieve an efficacy similar to that of the standard EBTM therapy. It may be very useful in countries where bismuth salts are not available. Compliance, CYP2C19 genotype and resistances to antibiotics may influence the outcome of levofloxacin-based rescue therapy. It seems advisable to reserve levofloxacin for rescue treatment to avoid an increase in the resistance phenomenon.