title: An open-label, non-comparative, non-interventional, multi-center, post-authorization safety study on the administration of rabeprazole to adults with gastro-esophageal reflux disease.
abstract: BACKGROUND
  Rabeprazole produces a profound and long-lasting inhibition of gastric acid secretion. The aim of the study was to monitor the safety and efficacy of rabeprazole administered to patients with erosive or symptomatic non-erosive reflux disease, in real-life healthcare settings.
  
  
  METHODS
  Male and female patients, aged ≥18 years, with endoscopy diagnosed GERD were included; patients received at least 8 weeks treatment with rabeprazole. Changes in severity of symptoms recorded on the Likert scale were analysed using marginal homogeneity tests.
  
  
  RESULTS
  186 patients were enrolled across 17 study sites; 127 patients (68.3%) completed the study. Almost 75% of patients had an initial diagnosis of GERD with Grade A or B esophagitis. The most commonly reported adverse events (AEs) were diarrhea, flatulence, dizziness, cough, abdominal pain, upper abdominal pain and somnolence. Over half of AEs were unrelated to study drug; 1 severe AE of diarrhea was possibly related to study drug. No new AEs were reported not included in the current version of Summary of Product Characteristics. Rabeprazole was effective in reducing the symptoms of GERD; the Likert scale scores of symptoms decreased significantly for all patients from 0-4 weeks and 4-8 weeks.
  
  
  CONCLUSIONS
  In our study, rabeprazole was safe and effective in reducing the symptoms of GERD.
authors.affiliation: First Department of Propaedeutic Medicine, Athens University Medical School "Laiko" General Hospital (Irini Zouboulis-Vafiadis, Nikolaos Katsilabros).
authors.forename: Irini
authors.initials: I
authors.lastname: Zouboulis-Vafiadis
authors.affiliation: Gastroenterology Department, Agios Savvas Hospital (Emmanuel Paraskevas).
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Paraskevas
authors.affiliation: Gastroenterology Department, Polycliniki Athinon (Dimitrios Tzourmakliotis).
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Tzourmakliotis
authors.affiliation: Janssen-Cilag (Maria Hatzikyriakou, Angeliki Mestoussi, Alexandra Papadokostopoulou).
authors.forename: Maria
authors.initials: M
authors.lastname: Hatzikyriakou
authors.affiliation: Janssen-Cilag (Maria Hatzikyriakou, Angeliki Mestoussi, Alexandra Papadokostopoulou).
authors.forename: Angeliki
authors.initials: A
authors.lastname: Mestoussi
authors.affiliation: Department of Statistics, Athens University of Economics and Business (Vassilios Vasdekis).
authors.forename: Vassilios
authors.initials: V
authors.lastname: Vasdekis
authors.affiliation: First Department of Propaedeutic Medicine, Athens University Medical School "Laiko" General Hospital (Irini Zouboulis-Vafiadis, Nikolaos Katsilabros).
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Katsilabros
authors.affiliation: Medical School, Athens University (Athanasios Archimandritis†), Athens, Greece.
authors.forename: Athanasios
authors.initials: A
authors.lastname: Arhimandritis
authors.affiliation: Janssen-Cilag (Maria Hatzikyriakou, Angeliki Mestoussi, Alexandra Papadokostopoulou).
authors.forename: Alexandra
authors.initials: A
authors.lastname: Papadokostopoulou
keywords: Rabeprazole; gastro-esophageal reflux disease; post-authorization safety study; real-life clinical practice
references.citation: Gastroenterology. 1996 Jul;111(1):85-92
references.pmid: 8698230
references.citation: J Clin Epidemiol. 1993 Mar;46(3):273-9
references.pmid: 8455052
references.citation: Expert Opin Drug Saf. 2009 Jan;8(1):119-26
references.pmid: 19236223
references.citation: Drugs. 2009 Jul 9;69(10):1373-401
references.pmid: 19583455
references.citation: Aliment Pharmacol Ther. 2002 Mar;16(3):445-54
references.pmid: 11876697