PMID- 24732963
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20211021
IS  - 1108-7471 (Print)
IS  - 1792-7463 (Electronic)
IS  - 1108-7471 (Linking)
VI  - 27
IP  - 2
DP  - 2014
TI  - 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.
PG  - 133-138
AB  - 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.
FAU - Zouboulis-Vafiadis, Irini
AU  - Zouboulis-Vafiadis I
AD  - First Department of Propaedeutic Medicine, Athens University Medical School 
      "Laiko" General Hospital (Irini Zouboulis-Vafiadis, Nikolaos Katsilabros).
FAU - Paraskevas, Emmanuel
AU  - Paraskevas E
AD  - Gastroenterology Department, Agios Savvas Hospital (Emmanuel Paraskevas).
FAU - Tzourmakliotis, Dimitrios
AU  - Tzourmakliotis D
AD  - Gastroenterology Department, Polycliniki Athinon (Dimitrios Tzourmakliotis).
FAU - Hatzikyriakou, Maria
AU  - Hatzikyriakou M
AD  - Janssen-Cilag (Maria Hatzikyriakou, Angeliki Mestoussi, Alexandra 
      Papadokostopoulou).
FAU - Mestoussi, Angeliki
AU  - Mestoussi A
AD  - Janssen-Cilag (Maria Hatzikyriakou, Angeliki Mestoussi, Alexandra 
      Papadokostopoulou).
FAU - Vasdekis, Vassilios
AU  - Vasdekis V
AD  - Department of Statistics, Athens University of Economics and Business (Vassilios 
      Vasdekis).
FAU - Katsilabros, Nikolaos
AU  - Katsilabros N
AD  - First Department of Propaedeutic Medicine, Athens University Medical School 
      "Laiko" General Hospital (Irini Zouboulis-Vafiadis, Nikolaos Katsilabros).
FAU - Arhimandritis, Athanasios
AU  - Arhimandritis A
AD  - Medical School, Athens University (Athanasios Archimandritisdagger), Athens, Greece.
FAU - Papadokostopoulou, Alexandra
AU  - Papadokostopoulou A
AD  - Janssen-Cilag (Maria Hatzikyriakou, Angeliki Mestoussi, Alexandra 
      Papadokostopoulou).
LA  - eng
PT  - Journal Article
PL  - Greece
TA  - Ann Gastroenterol
JT  - Annals of gastroenterology
JID - 101121847
PMC - PMC3982628
OTO - NOTNLM
OT  - Rabeprazole
OT  - gastro-esophageal reflux disease
OT  - post-authorization safety study
OT  - real-life clinical practice
COIS- Conflict of Interest: This study was sponsored by Janssen-Cilag, Greece
EDAT- 2014/04/16 06:00
MHDA- 2014/04/16 06:01
PMCR- 2014/01/01
CRDT- 2014/04/16 06:00
PHST- 2013/04/10 00:00 [received]
PHST- 2013/12/17 00:00 [accepted]
PHST- 2014/04/16 06:00 [entrez]
PHST- 2014/04/16 06:00 [pubmed]
PHST- 2014/04/16 06:01 [medline]
PHST- 2014/01/01 00:00 [pmc-release]
AID - AnnGastroenterol-27-133 [pii]
PST - ppublish
SO  - Ann Gastroenterol. 2014;27(2):133-138.