title: Optimised empiric triple and concomitant therapy for Helicobacter pylori eradication in clinical practice: the OPTRICON study.
abstract: BACKGROUND
  Empiric triple therapy for Helicobacter pylori should be abandoned when clarithromycin resistance rate is >15-20%. Optimisation of triple therapy (high-dose acid suppression and 14-day duration) can increase eradication rates by 10%.
  
  
  OBJECTIVE
  To compare the efficacy and safety of optimised triple (OPT-TRI) and nonbismuth quadruple concomitant (OPT-CON) therapies.
  
  
  METHODS
  Prospective multicentre study in 16 Spanish centres using triple therapy in clinical practice. In a 3-month two-phase fashion, the first 402 patients received an OPT-TRI therapy [esomeprazole (40 mg b.d.), amoxicillin (1 g b.d) and clarithromycin (500 mg b.d) for 14 days] and the last 375 patients an OPT-CON treatment [OPT-TRI therapy plus metronidazole (500 mg b.d)].
  
  
  RESULTS
  Seven-hundred seventy-seven consecutive patients were included (402 OPT-TRI, 375 OPT-CON). The OPT-CON therapy achieved significantly higher eradication rates in the per-protocol [82.3% (95% CI = 78-86%) vs. 93.8% (91-96%), P < 0.001] and intention-to-treat analysis [81.3% (78-86%) vs. 90.4% (87-93%), P < 0.001]. Adverse events (97% mild/moderate) were significantly more common with OPT-CON therapy (39% vs. 47%, P = 0.016), but full compliance with therapy was similar between groups (94% vs. 92%, P = 0.4). OPT-CON therapy was the only significant predictor of successful eradication (odds ratio, 2.24; 95% CI: 1.48-3.51, P < 0.001). The rate of participating centres achieving cure rates ≥ 90% favoured OPT-CON therapy (OPT-TRI 25% vs. OPT-CON 62%).
  
  
  CONCLUSIONS
  Empiric OPT-CON therapy achieved significantly higher cure rates (>90%) compared to OPT-TRI therapy. Addition of metronidazole to OPT-TRI therapy increased eradication rates by 10%, resulting in more mild adverse effects, but without impairing compliance with therapy.
authors.affiliation: Department of Gastroenterology, Hospital San Pedro de Alcantara, Caceres, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Molina-Infante
authors.forename: A J
authors.initials: AJ
authors.lastname: Lucendo
authors.forename: T
authors.initials: T
authors.lastname: Angueira
authors.forename: M
authors.initials: M
authors.lastname: Rodriguez-Tellez
authors.forename: A
authors.initials: A
authors.lastname: Perez-Aisa
authors.forename: A
authors.initials: A
authors.lastname: Balboa
authors.forename: J
authors.initials: J
authors.lastname: Barrio
authors.forename: E
authors.initials: E
authors.lastname: Martin-Noguerol
authors.forename: B J
authors.initials: BJ
authors.lastname: Gomez-Rodriguez
authors.forename: J M
authors.initials: JM
authors.lastname: Botargues-Bote
authors.forename: J
authors.initials: J
authors.lastname: Gomez-Camarero
authors.forename: A
authors.initials: A
authors.lastname: Huerta
authors.forename: I
authors.initials: I
authors.lastname: Modolell
authors.forename: I
authors.initials: I
authors.lastname: Ariño
authors.forename: M T
authors.initials: MT
authors.lastname: Herranz-Bachiller
authors.forename: F
authors.initials: F
authors.lastname: Bermejo
authors.forename: A G
authors.initials: AG
authors.lastname: McNicholl
authors.forename: C
authors.initials: C
authors.lastname: O'Morain
authors.forename: J P
authors.initials: JP
authors.lastname: Gisbert
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000658:Amoxicillin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017291:Clarithromycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D064098:Esomeprazole / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects* / Q000302:isolation & purification; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008795:Metronidazole / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D008795:Metronidazole; D000658:Amoxicillin; D017291:Clarithromycin; D064098:Esomeprazole