title: First-line eradication rates comparing two shortened non-bismuth quadruple regimens against Helicobacter pylori: an open-label, randomized, multicentre clinical trial.
abstract: OBJECTIVE
  Helicobacter pylori eradication remains a challenge. Non-bismuth-based quadruple regimens (NBQR) have shown high eradication rates (ER) elsewhere that need to be locally confirmed. The objective of this study was to compare the first-line ER of a hybrid therapy (20 mg of omeprazole twice daily and 1 g of amoxicillin twice daily for 10 days, adding 500 mg of clarithromycin twice daily and 500 mg of metronidazole every 8 h for the last 5 days; OA-OACM) with that of a 10 day concomitant regimen consisting of taking all four drugs twice daily every day (including 500 mg of metronidazole every 12 h; OACM). A 10 day arm with standard triple therapy (OAC; 20 mg of omeprazole/12 h, 1 g of amoxicillin/12 h and 500 mg of clarithromycin/12 h) was included.
  
  
  METHODS
  Three hundred consecutive patients were randomized (1: 2: 2) into one of the three following regimens: (i) OAC (60); (ii) OA-OACM (120); and (iii) OACM (120). Eradication was generally confirmed by a [(13)C]urea breath test at least 4 weeks after the end of treatment. Adverse events and compliance were assessed. EudraCT: 2011-006258-99.
  
  
  RESULTS
  ITT cure rates were: OAC, 70.0% (42/60) (95% CI: 58.3-81.7); OA-OACM, 90.8% (109/120) (95% CI: 85.6-96.0); and OACM, 90.0% (107/119) (95% CI: 84.6-95.4). PP rates were: OAC, 72.4% (42/58) (95% CI: 60.8-84.1); OA-OACM, 93.9% (108/115) (95% CI: 89.5-98.3); and OACM, 90.3% (102/113) (95% CI: 84.8-95.8). Both NBQR significantly improved ER compared with OAC (P < 0.01), but no differences were seen between them. Mean compliance was elevated [98.0% (SD = 9.8)] with no differences between groups. There were more adverse events in the quadruple arms (OACM, 65.8%; OA-OACM, 68.6%; OAC, 46.6%; P < 0.05), but no significant differences between groups in terms of severity were seen.
  
  
  CONCLUSIONS
  Hybrid and concomitant regimens show good ER against H. pylori infection with an acceptable safety profile. They clearly displace OAC as first-line regimen in our area.
authors: Department of Gastroenterology, Hospital Universitario Marqués de Valdecilla-Instituto de Investigación Marqués de Valdecilla (IDIVAL), Avda de Valdecilla s/n, 39008, Santander, Cantabria, Spain.
authors: Antonio
authors: A
authors: Cuadrado-Lavín
authors: Department of Gastroenterology, Hospital Comarcal de Laredo-IDIVAL, Avda Derechos Humanos s/n, 39770 Laredo, Cantabria, Spain.
authors: J Ramón
authors: JR
authors: Salcines-Caviedes
authors: Department of Gastroenterology, Hospital Comarcal de Laredo-IDIVAL, Avda Derechos Humanos s/n, 39770 Laredo, Cantabria, Spain.
authors: Ainhoa
authors: A
authors: Diaz-Perez
authors: Department of Internal Medicine, Hospital of Laredo-IDIVAL, Avda Derechos Humanos s/n, 39770 Laredo, Cantabria, Spain miguel.carrascosa@scsalud.es.
authors: Miguel F
authors: MF
authors: Carrascosa
authors: Department of Pharmacy, Hospital Universitario Marqués de Valdecilla-IDIVAL, Avda de Valdecilla s/n, 39008, Santander, Cantabria, Spain.
authors: María
authors: M
authors: Ochagavía
authors: Department of Gastroenterology, Hospital Comarcal Sierrallana, Barrio Ganzo, 39300 Torrelavega, Cantabria, Spain.
authors: José Luis
authors: JL
authors: Fernandez-Forcelledo
authors: Department of Gastroenterology, Hospital Comarcal de Laredo-IDIVAL, Avda Derechos Humanos s/n, 39770 Laredo, Cantabria, Spain.
authors: Marta
authors: M
authors: Cobo
authors: Department of Gastroenterology, Hospital Universitario Marqués de Valdecilla-Instituto de Investigación Marqués de Valdecilla (IDIVAL), Avda de Valdecilla s/n, 39008, Santander, Cantabria, Spain.
authors: Pedro
authors: P
authors: Fernández-Gil
authors: Department of Pharmacy, Hospital Comarcal de Laredo-IDIVAL, Avda Derechos Humanos s/n, 39770 Laredo, Cantabria, Spain.
authors: Blanca
authors: B
authors: Ayestarán
authors: Clinical Pharmacology Service-Clinical Trial Phase I Unit, Hospital Universitario Marqués de Valdecilla-IDIVAL, Avda de Valdecilla s/n, 39008 Santander, Cantabria, Spain.
authors: Blanca
authors: B
authors: Sánchez
authors: Clinical Trial Agency, IDIVAL, Edificio IDIVAL, Avda Cardenal Herrera Oria s/n, 39011 Santander, Cantabria, Spain.
authors: Cristina
authors: C
authors: Campo
authors: Group of Epidemiology and Computational Biology, University of Cantabria-IDIVAL, Santander, Cantabria, Spain Consorcio de Investigación Biomédica en Red de Epidemiología y Salud Pública, Spain.
authors: Javier
authors: J
authors: Llorca
authors: Department of Pharmacy, Hospital Comarcal Sierrallana, Barrio Ganzo, 39300 Torrelavega, Cantabria, Spain.
authors: Silvia
authors: S
authors: Lorenzo
authors: Department of Pharmacy, Hospital Universitario Marqués de Valdecilla-IDIVAL, Avda de Valdecilla s/n, 39008, Santander, Cantabria, Spain.
authors: Aitziber
authors: A
authors: Illaro
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D001944:Breath Tests; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome; D014508:Urea / Q000032:analysis; D055815:Young Adult
chemical_list: D000890:Anti-Infective Agents; D054328:Proton Pump Inhibitors; D014508:Urea
keywords: H. pylori; concomitant; hybrid; non-bismuth-based quadruple regimens; randomized clinical trials