title: Second-line rescue therapy with levofloxacin after H. pylori treatment failure: a Spanish multicenter study of 300 patients.
abstract: OBJECTIVE
  Quadruple therapy is generally recommended as second-line therapy after Helicobacter pylori (H. pylori) eradication failure. However, this regimen requires the administration of four drugs with a complex scheme, is associated with a relatively high incidence of adverse effects, and bismuth salts are not available worldwide anymore. Our aim was to evaluate the efficacy and tolerability of a triple second-line levofloxacin-based regimen in patients with H. pylori eradication failure.
  
  
  METHODS
  
  
  
  METHODS
  Prospective multicenter study.
  
  
  METHODS
  in whom a first treatment with proton pump inhibitor-clarithromycin-amoxicillin had failed.
  
  
  METHODS
  A second eradication regimen with levofloxacin (500 mg b.i.d.), amoxicillin (1 g b.i.d.), and omeprazole (20 mg b.i.d.) was prescribed for 10 days.
  
  
  RESULTS
  Eradication was confirmed with (13)C-urea breath test 4-8 wk after therapy. Compliance with therapy was determined from the interview and the recovery of empty envelopes of medications. Incidence of adverse effects was evaluated by means of a specific questionnaire.
  
  
  RESULTS
  Three hundred consecutive patients were included. Mean age was 48 yr, 47% were male, 38% had peptic ulcer, and 62% functional dyspepsia. Almost all (97%) patients took all the medications correctly. Per-protocol and intention-to-treat eradication rates were 81% (95% CI 77-86%) and 77% (73-82%). Adverse effects were reported in 22% of the patients, mainly including nausea (8%), metallic taste (5%), abdominal pain (3%), and myalgias (3%); none of them were severe.
  
  
  CONCLUSIONS
  Ten-day levofloxacin-based rescue therapy constitutes an encouraging second-line strategy, representing an alternative to quadruple therapy in patients with previous proton pump inhibitor-clarithromycin-amoxicillin failure, being simple and safe.
authors.affiliation: Hospital de la Princesa, Madrid.
authors.forename: Javier P
authors.initials: JP
authors.lastname: Gisbert
authors.forename: Fernando
authors.initials: F
authors.lastname: Bermejo
authors.forename: Manuel
authors.initials: M
authors.lastname: Castro-Fernández
authors.forename: Angeles
authors.initials: A
authors.lastname: Pérez-Aisa
authors.forename: Miguel
authors.initials: M
authors.lastname: Fernández-Bermejo
authors.forename: Albert
authors.initials: A
authors.lastname: Tomas
authors.forename: José
authors.initials: J
authors.lastname: Barrio
authors.forename: Felipe
authors.initials: F
authors.lastname: Bory
authors.forename: Pedro
authors.initials: P
authors.lastname: Almela
authors.forename: Pilar
authors.initials: P
authors.lastname: Sánchez-Pobre
authors.forename: Angel
authors.initials: A
authors.lastname: Cosme
authors.forename: Vicente
authors.initials: V
authors.lastname: Ortiz
authors.forename: Pilar
authors.initials: P
authors.lastname: Niño
authors.forename: Sam
authors.initials: S
authors.lastname: Khorrami
authors.forename: Luis-Miguel
authors.initials: LM
authors.lastname: Benito
authors.forename: Jose-Antonio
authors.initials: JA
authors.lastname: Carneros
authors.forename: Eloisa
authors.initials: E
authors.lastname: Lamas
authors.forename: Inés
authors.initials: I
authors.lastname: Modolell
authors.forename: Alejandro
authors.initials: A
authors.lastname: Franco
authors.forename: Juan
authors.initials: J
authors.lastname: Ortuño
authors.forename: Luis
authors.initials: L
authors.lastname: Rodrigo
authors.forename: Fernando
authors.initials: F
authors.lastname: García-Durán
authors.forename: Elena
authors.initials: E
authors.lastname: O'Callaghan
authors.forename: Julio
authors.initials: J
authors.lastname: Ponce
authors.forename: María-Paz
authors.initials: MP
authors.lastname: Valer
authors.forename: Xavier
authors.initials: X
authors.lastname: Calvet
mesh_terms: D000658:Amoxicillin / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001944:Breath Tests; D017291:Clarithromycin / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005500:Follow-Up Studies; D005753:Gastric Mucosa / Q000382:microbiology / Q000473:pathology; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects / Q000302:isolation & purification*; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000627:therapeutic use*; D009853:Omeprazole / Q000627:therapeutic use*; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D017211:Treatment Failure; D014508:Urea / Q000032:analysis
chemical_list: D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D064704:Levofloxacin; D000658:Amoxicillin; D014508:Urea; D015242:Ofloxacin; D017291:Clarithromycin; D009853:Omeprazole