Background: Levofloxacin is an effective medication for second line Helicobacter pylori (H. pylori) eradication.However, limited studies have approved its use as an effective antibiotic in first line therapy. Dexlansoprazole isa new PPI and lacks of evidence in support of a role in H. pylori eradication. This study was designed to evaluateefficacy of levofloxacin-dexlansoprazole-based quadruple therapy for H. pylori eradication in Thailand. Materialsand
Methods: This prospective randomized control study was performed during June 2014 to December 2014.H. pylori infected gastritis patients were randomized to receive 7- or 14-day levofloxacin-dexlansoprazole basedon quadruple therapy (levofloxacin 500 mg OD, dexlansoprazole 60 mg bid, clarithromycin MR 1000 mg OD,bismuth subsalicylate 1048 mg bid). CYP2C19 genotyping and antibiotic susceptibility tests were conductedfor all patients. A 13C urea breath test was performed to confirm H. pylori eradication at least 4 weeks aftertreatment.
Results: A total of 100 patients were enrolled, comprising 44 males and 56 females (mean age of 52.6years). Eradication rate by PP analysis was 85.7% (42/49) with the 7-day regimen and 98% (48/49) with the14-day regimen (85.7% vs 98%; p-value=0.059). ITT analysis was 84% and 96% with 7- and 14-day regimens,respectively (84% vs 96%; p-value=0.092). Antibiotic susceptibility testing demonstrated 35.1% resistance tometronidazole, 18.3% to clarithromycin, and 13.5% to levofloxacin. CYP2C19 genotyping revealed 54.1% RM,34.7% IM and 11.2% PM. The 14-day regimen provided 100% eradication in patients with clarithromycin or dualclarithromycin and metronidazole H. pylori resistant strains. Moreover, the eradication rate was 96.6% in patientswith CYP2C19 genotype RM.
Conclusions: The 14-day levofloxacin-dexlansoprazole based quadruple therapyprovides high H. pylori eradication regardless of CYP2C19 genotype, clarithromycin or dual clarithromycinand metronidazole resistant strains. This regimen could be use as an alternative first line therapy for H. pylorieradication in Thailand.