title: High-dose esomeprazole and amoxicillin dual therapy for first-line Helicobacter pylori eradication: a proof of concept study.
abstract: BACKGROUND
  The prevalence of resistance to clarithromycin and metronidazole has considerably increased, with a corresponding decrease in the eradication rate for Helicobacter pylori (H. pylori) infection. Primary resistance to amoxicillin is extremely low, and esomeprazole was found to exert a noteworthy antimicrobial activity in vitro against H. pylori. A dual therapy with high-dose of esomeprazole coupled with high-dose amoxicillin might be therefore an ideal first-line treatment for H. pylori eradication. We aimed to assess the efficacy of a first-line 10-day, high-dose dual therapy consisting of amoxicillin and esomeprazole to eradicate H. pylori infection.
  
  
  METHODS
  Consecutive naïve H. pylori-infected patients, who underwent an upper endoscopy in 4 Italian hospitals due to dyspeptic symptoms and found to be infected at routine histological assessment, were invited to participate. Patients enrolled received a 10-day, high-dose dual therapy comprising esomeprazole (40 mg t.i.d) and amoxicillin (1 g t.i.d.). At least 4 weeks after the end of the treatment a (13)C-urea breath test was performed to evaluate the eradication.
  
  
  RESULTS
  A total of 56 patients agreed to participate in the study and were all followed-up. The overall eradication was 87.5% (95% CI=78.8•96.2), without a statistically significant difference among centres. Overall, 5 (8.9%; 1.5•16.4%) patients complained of side-effects.
  
  
  CONCLUSIONS
  The 10-day, high-dose dual therapy with esomeprazole and amoxicillin might be an effective and safe first-line regimen. The efficacy of a longer 14-day regimen should be tested.
authors.affiliation: Gastroenterology and Digestive Endoscopy, 'Nuovo Regina Margherita' Hospital, Rome (Angelo Zullo, Cesare Hassan), Italy.
authors.forename: Angelo
authors.initials: A
authors.lastname: Zullo
authors.affiliation: Gastroenterology Unit, Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome (Lorenzo Ridola), Italy.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Ridola
authors.affiliation: Gastroenterology Unit, 'Riuniti' Hospital, Foggia (Vincenzo De Francesco, Annamaria Bellesia), Italy.
authors.forename: Vincenzo De
authors.initials: VD
authors.lastname: Francesco
authors.affiliation: Gastroenterology and Endoscopy Unit, Versilia Hospital, Lido di Camaiore (Luigi Gatta), Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Gatta
authors.affiliation: Gastroenterology and Digestive Endoscopy, 'Nuovo Regina Margherita' Hospital, Rome (Angelo Zullo, Cesare Hassan), Italy.
authors.forename: Cesare
authors.initials: C
authors.lastname: Hassan
authors.affiliation: Gastroenterology Unit, Sapienza University of Rome "Polo Pontino" Hospital, Latina (Domenico Alvaro), Italy.
authors.forename: Domenico
authors.initials: D
authors.lastname: Alvaro
authors.affiliation: Gastroenterology Unit, 'Riuniti' Hospital, Foggia (Vincenzo De Francesco, Annamaria Bellesia), Italy.
authors.forename: Annamaria
authors.initials: A
authors.lastname: Bellesia
authors.affiliation: Department of Gastroenterology "Salvini" Hospital, Garbagnate, Milan (Germana de Nucci, Gianpiero Manes), Italy.
authors.forename: Germana
authors.initials: G
authors.lastname: de Nucci
authors.affiliation: Department of Gastroenterology "Salvini" Hospital, Garbagnate, Milan (Germana de Nucci, Gianpiero Manes), Italy.
authors.forename: Gianpiero
authors.initials: G
authors.lastname: Manes
keywords: Helicobacter pylori infection; amoxicillin; dual therapy; esomeprazole