Efficacy and safety of Levofloxacin, Clarithromycin and Esomeprazol as first line triple therapy for Helicobacter pylori eradication in Middle East. Prospective, randomized, blind, comparative, multicenter study

Abstract

Background/aims Antibiotic resistance and poor compliance are the main causes of Helicobacter pylori ( H. pylori ) eradication failure. This study evaluated the eradication rate, tolerability, and compliance of Levofloxacin, Clarithromycin and Esomeprazol combined triple therapy for H. pylori eradication. Patients and methods Four hundred-fifty patients from 3 centres who were diagnosed to have Helicobacter pylori infection by 13C-urea breath test were randomized into 3 equal groups; group 1 (CAE) received Clarithromycin 500 mg twice daily, Amoxicillin 1000 mg twice daily, plus Esomeprazol 20 mg twice daily for 7 days, group 2 (LAE) received Levofloxacin 500 mg once daily, Amoxicillin 1000 mg twice daily, plus Esomeprazol 20 mg twice daily for 7 days, group 3 (CLE) received Levofloxacin 500 mg once daily, Clarithromycin 500 mg twice daily, plus Esomeprazol 20 mg twice daily for 7 days. 436 patients were re-evaluated by 13C-urea breath test after 6 weeks from completion of treatment. Results H. pylori eradication (intention to treat) was successful in 136/150 (90.6%) with CLE, 127/150 (84.7%) with LAE and 118/150 (78.6%) with CAE. There was a significant difference ( p < 0.001) regarding treatment success between CLE and LAE when compared with CAE. There was no difference among the treatment groups with regard to the incidence and severity of adverse events reported. Conclusion The combined Levofloxacin, and Clarithromycin and Esomeprazol based regimen as first line triple therapy for H. pylori eradication can give more significant eradication rate with same safety when compared with classic triple therapy.