An open-label, non-comparative, nonâ€‘interventional, multi-center, postâ€‘authorization safety study on the administration of rabeprazole to adults with gastroâ€‘esophageal reflux disease
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 â‰¥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.
Keywords Rabeprazole, post-authorization safety study, gastro-esophageal reflux disease, real-life clinical practice
Ann Gastroenterol 2014; 27 (2): 133-138