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Empirical levofloxacin-containing versus clarithromycin-containing sequential therapy for Helicobacter pylori eradication: a randomised trial
  1. Marco Romano1,
  2. Antonio Cuomo2,
  3. Antonietta G Gravina1,
  4. Agnese Miranda1,
  5. Maria Rosaria Iovene3,
  6. Angelo Tiso1,
  7. Mariano Sica4,
  8. Alba Rocco4,
  9. Raffaele Salerno5,
  10. Riccardo Marmo6,
  11. Alessandro Federico1,
  12. Gerardo Nardone4
  1. 1Dipartimento Medico Chirurgico di Internistica Clinica e Sperimentale ed UOC di Gastroenterologia, Azienda Ospedaliera Universitaria, Seconda Università di Napoli, Napoli, Italy
  2. 2Servizio di Gastroenterologia, Ospedale Umberto I, Nocera Inferiore (SA), Italy
  3. 3Servizio di Microbiologia Clinica, Azienda Ospedaliera Universitaria, Seconda Università di Napoli, Italy
  4. 4Dipartimento di Medicina Clinica e Sperimentale-Area Funzionale di Gastroenterologia, Università Federico II, Napoli, Italy
  5. 5Servizio di Endoscopia Digestiva, Ospedale Maresca, Torre del Greco (NA), Italy
  6. 6Unità Operativa di Gastroenterologia, Azienda Ospedaliera Salerno, Presidio Ospedaliero Polla (SA), Italy
  1. Correspondence to Dr Marco Romano, c/o II Policlinico, Edifico 3, IV piano, Via Pansini 5, 80131 Napoli, Italy; marco.romano{at}unina2.it

Abstract

Background and aims Antimicrobial 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.

Methods 375 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.

Results Eradication 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.

Conclusion In 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.

  • H pylori, sequential therapy
  • levofloxacin

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Footnotes

  • Competing interests None.

  • Ethics approval This study was conducted with the approval of the Ethics Committee of the Second University of Naples, Italy.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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