title: Efficacy of 5-day levofloxacin-containing concomitant therapy in eradication of Helicobacter pylori infection.
abstract: OBJECTIVE
  Helicobacter pylori have become resistant to antimicrobial agents, reducing eradication rates. A 10-day sequential regimen that contains levofloxacin was efficient, safe, and cost saving in eradicating H pylori infection in an area with high prevalence of clarithromycin resistance. We performed a noninferiority randomized trial to determine whether a 5-day levofloxacin-containing quadruple concomitant regimen was as safe and effective as the 10-day sequential regimen in eradicating H pylori in previously untreated patients.
  
  
  METHODS
  We randomly assigned patients with H pylori infection to groups that were given 5 days of concomitant therapy (esomeprazole 40 mg twice daily, amoxicillin 1 g twice daily, levofloxacin 500 mg twice daily, and tinidazole 500 mg twice daily; n = 90) or 10 days of sequential therapy (esomeprazole 40 mg twice daily, amoxicillin 1g twice daily for 5 days followed by esomeprazole 40 mg twice daily, levofloxacin 500 mg twice daily, and tinidazole 500 mg twice daily for 5 more days; n = 90). Antimicrobial resistance was assessed by the E-test. Efficacy, adverse events, and costs were determined.
  
  
  RESULTS
  Intention-to-treat analysis showed similar eradication rates for concomitant (92.2%; 95% confidence interval [CI], 84.0%-95.8%) and sequential therapies (93.3%; 95% CI, 86.9%-97.3%). Per-protocol eradication results were 96.5% (95% CI, 91%-99%) for concomitant therapy and 95.5% for sequential therapy (95% CI, 89.6%-98.5%). The differences between sequential and concomitant treatments were 1.1% in the intention-to-treat study (95% CI; -7.6% to 9.8%) and -1.0% in the per-protocol analysis (95% CI; -8.0% to 5.9%). The prevalence of antimicrobial resistance and incidence of adverse events were comparable between groups. Concomitant therapy cost $9 less than sequential therapy.
  
  
  CONCLUSIONS
  Five days of levofloxacin-containing quadruple concomitant therapy is as effective and safe, and less expensive, in eradicating H pylori infection than 10 days of levofloxacin-containing sequential therapy.
authors.affiliation: Dipartimento Medico Chirurgico di Internistica Clinica e Sperimentale ed UOC di Gastroenterologia e, Napoli, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Federico
authors.forename: Gerardo
authors.initials: G
authors.lastname: Nardone
authors.forename: Antonietta G
authors.initials: AG
authors.lastname: Gravina
authors.forename: Maria Rosaria
authors.initials: MR
authors.lastname: Iovene
authors.forename: Agnese
authors.initials: A
authors.lastname: Miranda
authors.forename: Debora
authors.initials: D
authors.lastname: Compare
authors.forename: Paola A
authors.initials: PA
authors.lastname: Pilloni
authors.forename: Alba
authors.initials: A
authors.lastname: Rocco
authors.forename: Luigi
authors.initials: L
authors.lastname: Ricciardiello
authors.forename: Riccardo
authors.initials: R
authors.lastname: Marmo
authors.forename: Carmelina
authors.initials: C
authors.lastname: Loguercio
authors.forename: Marco
authors.initials: M
authors.lastname: Romano
mesh_terms: D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D064098:Esomeprazole / Q000008:administration & dosage; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000008:administration & dosage*; D011446:Prospective Studies; D014011:Tinidazole / Q000008:administration & dosage; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D014011:Tinidazole; D064704:Levofloxacin; D000658:Amoxicillin; D015242:Ofloxacin; D064098:Esomeprazole