Journal Article

Empirical levofloxacin-containing versus clarithromycin-containing sequential therapy for Helicobacter pylori eradication: a randomised trial

Romano, Marco, Federico, Alessandro, Miranda, Agnese, Tiso, Angelo, Nardone, Gerardo, Salerno, Raffaele, Iovene, Maria Rosaria, Sica, Mariano, Gravina, Antonietta G, Marmo, Riccardo, Cuomo, Antonio, Rocco, Alba

2010

Overview

Background and aimsAntimicrobial drug resistance is a major cause of the failure of Helicobacter pylori eradication and is largely responsible for the decline in eradication rate. Quadruple therapy has been suggested as a first-line regimen in areas with clarithromycin resistance rate >15%. This randomised trial aimed at evaluating the efficacy of a levofloxacin-containing sequential regimen in the eradication of H pylori-infected patients in a geographical area with >15% prevalence of clarithromycin resistance versus a clarithromycin-containing sequential therapy.Methods375 patients who were infected with H pylori and naïve to treatment were randomly assigned to one of the following treatments: (1) 5 days omeprazole 20 mg twice daily + amoxicillin 1 g twice daily followed by 5 days omeprazole 20 mg twice daily + clarithromycin 500 mg twice daily + tinidazole 500 mg twice daily; or (2) omeprazole 20 mg twice daily + amoxicillin 1 g twice daily followed by omeprazole 20 mg twice daily + levofloxacin 250 mg twice daily + tinidazole 500 mg twice daily; or (3) omeprazole 20 mg twice daily + amoxicillin 1 g twice daily followed by omeprazole 20 mg twice daily + levofloxacin 500 mg twice daily + tinidazole 500 mg twice daily. Antimicrobial resistance was assessed by the E-test. Efficacy, adverse events and costs were determined for each group.ResultsEradication rates in the intention-to-treat analyses were 80.8% (95% CI, 72.8% to 87.3%) with clarithromycin sequential therapy, 96.0% (95% CI, 90.9% to 98.7%) with levofloxacin-250 sequential therapy, and 96.8% (95% CI, 92.0% to 99.1%) with levofloxacin-500 sequential therapy. No differences in prevalence of antimicrobial resistance or incidence of adverse events were observed between groups. Levofloxacin-250 therapy was cost-saving compared with clarithromycin sequential therapy.ConclusionIn an area with >15% prevalence of clarithromycin resistant H pylori strains, a levofloxacin-containing sequential therapy is more effective, equally safe and cost-saving compared to a clarithromycin-containing sequential therapy.

• Publisher: BMJ Publishing Group Ltd and British Society of Gastroenterology,BMJ Publishing Group,BMJ Publishing Group LTD
• Subject: Adolescent / Adult / Aged / Anti-Bacterial Agents - administration & dosage / Anti-Bacterial Agents - adverse effects / Anti-Bacterial Agents - economics / Antibacterial agents / Antibiotics. Antiinfectious agents. Antiparasitic agents / Antimicrobial agents / Bacterial diseases / Bacterial diseases of the digestive system and abdomen / Biological and medical sciences / Clarithromycin - administration & dosage / Clarithromycin - adverse effects / Clarithromycin - economics / Clinical medicine / Cost analysis / Drug Costs - statistics & numerical data / Drug dosages / Drug Resistance, Bacterial / Drug Therapy, Combination - methods / Endoscopy / Female / Gastroenterology / Gastroenterology. Liver. Pancreas. Abdomen / H pylori / Helicobacter Infections - drug therapy / Helicobacter pylori / Helicobacter pylori - drug effects / Human bacterial diseases / Humans / Infections / Infectious diseases / Levofloxacin / Male / Medical sciences / Middle Aged / Ofloxacin - administration & dosage / Ofloxacin - adverse effects / Ofloxacin - economics / Pain / Pharmacology. Drug treatments / Prospective Studies / sequential therapy / Treatment Outcome / Ulcers / Young Adult