Effect of Fluoroquinolone Resistance on 14‐day Levofloxacin Triple and Triple Plus Bismuth Quadruple Therapy

Abstract

AbstractObjectiveLevofloxacin has been proposed to replace clarithromycin for Helicobacter pylori treatment. Seven‐ and 10‐day fluoroquinolone triple therapies have generally failed to achieve cure rates of ≥90%, whereas 14‐day therapy has achieved 95% success. The aim was to assess the efficacy and effect of fluoroquinolone resistance on 14‐day levofloxacin‐containing triple therapy with or without the addition of bismuth.DesignHelicobacter pylori‐positive patients with functional dyspepsia or healed peptic ulcers were randomized to receive lansoprazole 30 mg b.i.d., amoxicillin 1000 mg b.i.d., and levofloxacin 500 mg daily with (B‐LAL) or without (LAL) bismuth potassium citrate 220 mg b.i.d. for 14 days. Eradication was assessed by 13C‐urea breath testing 4 weeks after completing treatment. Antimicrobial susceptibility was by the agar dilution method. Success was defined as PP success ≥90%.ResultsA total of 152 of 161 patients (81 LAL and 80 B‐LAL) enrolled completed treatment. The PP rates were 94.6% (70/74; 95% CI, 86.9–97.9%) with B‐LAL and 85.9% (95% CI, 76.5–91.9%) with LAL (p = .07); the ITT eradication rates were 87.5% (95% CI, 78.5–93.1%) with B‐LAL and 82.7% (95% CI, 73–89.4%) with LAL (p = .39). Levofloxacin resistance was present in 30.3%. Treatment success was excellent with susceptible strains (97.5%) versus resistant strains (70.6%) for B‐LAL and 97.3% versus 37.5% for LAL, respectively.ConclusionsFourteen‐day fluoroquinolone therapy was highly effective when fluoroquinolone resistance rates are <12%. The addition of bismuth maintained effectiveness with fluoroquinolone resistance as high as 25%.