title: Beyond Maastricht IV: are standard empiric triple therapies for Helicobacter pylori still useful in a South-European country?
abstract: BACKGROUND
  Empiric triple treatments for Helicobacter pylori (H. pylori) are increasingly unsuccessful. We evaluated factors associated with failure of these treatments in the central region of Portugal.
  
  
  METHODS
  This single-center, prospective study included 154 patients with positive (13)C-urea breath test (UBT). Patients with no previous H. pylori treatments (Group A, n = 103) received pantoprazole 40 mg 2×/day, amoxicillin 1000 mg 12/12 h and clarithromycin (CLARI) 500 mg 12/12 h, for 14 days. Patients with previous failed treatments (Group B, n = 51) and no history of levofloxacin (LVX) consumption were prescribed pantoprazole 40 mg 2×/day, amoxicillin 1000 mg 12/12 h and LVX 250 mg 12/12 h, for 10 days. H. pylori eradication was assessed by UBT 6-10 weeks after treatment. Compliance and adverse events were assessed by verbal and written questionnaires. Risk factors for eradication failure were determined by multivariate analysis.
  
  
  RESULTS
  Intention-to-treat and per-protocol eradication rates were Group A: 68.9% (95% CI: 59.4-77.1%) and 68.8% (95% CI: 58.9-77.2%); Group B: 52.9% (95% CI: 39.5-66%) and 55.1% (95% CI: 41.3-68.2%), with 43.7% of Group A and 31.4% of Group B reporting adverse events. Main risk factors for failure were H. pylori resistance to CLARI and LVX in Groups A and B, respectively. Another independent risk factor in Group A was history of frequent infections (OR = 4.24; 95% CI 1.04-17.24). For patients with no H. pylori resistance to CLARI, a history of frequent infections (OR = 4.76; 95% CI 1.24-18.27) and active tobacco consumption (OR = 5.25; 95% CI 1.22-22.69) were also associated with eradication failure.
  
  
  CONCLUSIONS
  Empiric first and second-line triple treatments have unacceptable eradication rates in the central region of Portugal and cannot be used, according to Maastricht recommendations. Even for cases with no H. pylori resistance to the used antibiotics, results were unacceptable and, at least for CLARI, are influenced by history of frequent infections and tobacco consumption.
authors.affiliation: Gastroenterology Department, Centro Hospitalar e Universitário de Coimbra, Praceta Mota Pinto e Avenida Bissaya Barreto, 3000-075, Coimbra, Portugal. nunoperesalmeida@gmail.com.
authors.forename: Nuno
authors.initials: N
authors.lastname: Almeida
authors.affiliation: Gastroenterology Centre, Faculty of Medicine, Coimbra University, Praceta Mota Pinto e Avenida Bissaya Barreto, 3000-075, Coimbra, Portugal. mariamanueldonato@gmail.com.
authors.forename: Maria Manuel
authors.initials: MM
authors.lastname: Donato
authors.affiliation: Gastroenterology Department, Centro Hospitalar e Universitário de Coimbra, Praceta Mota Pinto e Avenida Bissaya Barreto, 3000-075, Coimbra, Portugal. jmromaozinho@gmail.com.|Gastroenterology Centre, Faculty of Medicine, Coimbra University, Praceta Mota Pinto e Avenida Bissaya Barreto, 3000-075, Coimbra, Portugal. jmromaozinho@gmail.com.
authors.forename: José Manuel
authors.initials: JM
authors.lastname: Romãozinho
authors.affiliation: Laboratory of Microbiology, Faculty of Pharmacy, Coimbra University, Azinhaga de Santa Comba, 3000-548, Coimbra, Portugal. crisluxo@ci.uc.pt.
authors.forename: Cristina
authors.initials: C
authors.lastname: Luxo
authors.affiliation: Laboratory of Microbiology, Faculty of Pharmacy, Coimbra University, Azinhaga de Santa Comba, 3000-548, Coimbra, Portugal. ocardoso@ci.uc.pt.
authors.forename: Olga
authors.initials: O
authors.lastname: Cardoso
authors.affiliation: Pathology Department, Coimbra University Hospital Centre, Praceta Mota Pinto e Avenida Bissaya Barreto, 3000-075, Coimbra, Portugal. augustacipriano@gmail.com.
authors.forename: Maria Augusta
authors.initials: MA
authors.lastname: Cipriano
authors.affiliation: Pathology Department, Coimbra University Hospital Centre, Praceta Mota Pinto e Avenida Bissaya Barreto, 3000-075, Coimbra, Portugal. carol.marinho@huc.min-saude.pt.
authors.forename: Carol
authors.initials: C
authors.lastname: Marinho
authors.affiliation: Gastroenterology Department, Centro Hospitalar e Universitário de Coimbra, Praceta Mota Pinto e Avenida Bissaya Barreto, 3000-075, Coimbra, Portugal. xanafmuc@hotmail.com.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Fernandes
authors.affiliation: Gastroenterology Centre, Faculty of Medicine, Coimbra University, Praceta Mota Pinto e Avenida Bissaya Barreto, 3000-075, Coimbra, Portugal. carloscalhau1@gmail.com.
authors.forename: Carlos
authors.initials: C
authors.lastname: Calhau
authors.affiliation: Gastroenterology Department, Centro Hospitalar e Universitário de Coimbra, Praceta Mota Pinto e Avenida Bissaya Barreto, 3000-075, Coimbra, Portugal. carlos.sofia@huc.min-saude.pt.|Gastroenterology Centre, Faculty of Medicine, Coimbra University, Praceta Mota Pinto e Avenida Bissaya Barreto, 3000-075, Coimbra, Portugal. carlos.sofia@huc.min-saude.pt.
authors.forename: Carlos
authors.initials: C
authors.lastname: Sofia
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D001944:Breath Tests; D017291:Clarithromycin / Q000627:therapeutic use*; D024881:Drug Resistance, Bacterial / Q000235:genetics; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000235:genetics; D006801:Humans; D064704:Levofloxacin / Q000627:therapeutic use*; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D009593:Nitroimidazoles / Q000627:therapeutic use; D000077402:Pantoprazole; D011174:Portugal; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D017211:Treatment Failure; D055815:Young Adult
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000900:Anti-Bacterial Agents; D009593:Nitroimidazoles; D054328:Proton Pump Inhibitors; D064704:Levofloxacin; D000658:Amoxicillin; D000077402:Pantoprazole; D017291:Clarithromycin