title: Third-line rescue therapy with bismuth-containing quadruple regimen after failure of two treatments (with clarithromycin and levofloxacin) for H. pylori infection.
abstract: BACKGROUND
  Helicobacter pylori eradication therapy with a proton pump inhibitor (PPI), clarithromycin, and amoxicillin fails in >20 % of cases. A rescue therapy with PPI-amoxicillin-levofloxacin still fails in >20 % of patients.
  
  
  OBJECTIVE
  To evaluate the efficacy and tolerability of a bismuth-containing quadruple regimen in patients with two consecutive eradication failures.
  
  
  METHODS
  Prospective multicenter study of patients in whom 1st treatment with PPI-clarithromycin-amoxicillin and 2nd with PPI-amoxicillin-levofloxacin had failed. A 3rd eradication regimen with a 7- to 14-day PPI (standard dose b.i.d.), bismuth subcitrate (120 mg q.i.d. or 240 mg b.i.d.), tetracycline (from 250 mg t.i.d. to 500 mg q.i.d.) and metronidazole (from 250 mg t.i.d. to 500 mg q.i.d.). Eradication was confirmed by (13)C-urea-breath-test 4-8 weeks after therapy. Compliance was determined through questioning and recovery of empty medication envelopes. Adverse effects were evaluated by means of a questionnaire.
  
  
  RESULTS
  Two hundred patients (mean age 50 years, 55 % females, 20 % peptic ulcer/80 % uninvestigated-functional dyspepsia) were initially included, and two were lost to follow-up. In all, 97 % of patients complied with the protocol. Per-protocol and intention-to-treat eradication rates were 67 % (95 % CI 60-74 %) and 65 % (58-72 %). Adverse effects were reported in 22 % of patients, the most common being nausea (12 %), abdominal pain (11 %), metallic taste (8.5 %), and diarrhea (8 %), none of them severe.
  
  
  CONCLUSIONS
  A bismuth-containing quadruple regimen is an acceptable third-line strategy and a safe alternative after two previous H. pylori eradication failures with standard clarithromycin- and levofloxacin-containing triple therapies.
authors.affiliation: Gastroenterology Unit, Hospital Universitario de La Princesa and Instituto de Investigación Sanitaria Princesa (IP), Playa de Mojácar 29. Urb. Bonanza., 28669, Boadilla del Monte, Madrid, Spain, gisbert@meditex.es.
authors.forename: J P
authors.initials: JP
authors.lastname: Gisbert
authors.forename: A
authors.initials: A
authors.lastname: Perez-Aisa
authors.forename: L
authors.initials: L
authors.lastname: Rodrigo
authors.forename: J
authors.initials: J
authors.lastname: Molina-Infante
authors.forename: I
authors.initials: I
authors.lastname: Modolell
authors.forename: F
authors.initials: F
authors.lastname: Bermejo
authors.forename: M
authors.initials: M
authors.lastname: Castro-Fernández
authors.forename: R
authors.initials: R
authors.lastname: Antón
authors.forename: B
authors.initials: B
authors.lastname: Sacristán
authors.forename: A
authors.initials: A
authors.lastname: Cosme
authors.forename: J
authors.initials: J
authors.lastname: Barrio
authors.forename: Y
authors.initials: Y
authors.lastname: Harb
authors.forename: M
authors.initials: M
authors.lastname: Gonzalez-Barcenas
authors.forename: M
authors.initials: M
authors.lastname: Fernandez-Bermejo
authors.forename: A
authors.initials: A
authors.lastname: Algaba
authors.forename: A C
authors.initials: AC
authors.lastname: Marín
authors.forename: A G
authors.initials: AG
authors.lastname: McNicholl
mesh_terms: D000328:Adult; D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D017291:Clarithromycin / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects* / Q000302:isolation & purification; D006801:Humans; D064704:Levofloxacin / Q000627:therapeutic use*; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use; D008875:Middle Aged; D009942:Organometallic Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D016879:Salvage Therapy; D013030:Spain; D011795:Surveys and Questionnaires; D013752:Tetracycline / Q000627:therapeutic use; D013997:Time Factors; D017211:Treatment Failure
chemical_list: D000900:Anti-Bacterial Agents; D009942:Organometallic Compounds; D054328:Proton Pump Inhibitors; D008795:Metronidazole; D064704:Levofloxacin; D000658:Amoxicillin; D013752:Tetracycline; D017291:Clarithromycin; C002791:bismuth tripotassium dicitrate