Randomised clinical trial: a multicentre, double-blind, placebo-controlled study on the efficacy and safety of rabeprazole 5 mg or 10 mg once daily in patients with non-erosive reflux disease
- 14 November 2010
- journal article
- research article
- Published by Wiley in Alimentary Pharmacology & Therapeutics
- Vol. 33 (2), 213-224
- https://doi.org/10.1111/j.1365-2036.2010.04508.x
Abstract
The efficacy of rabeprazole 5 mg/day for patients with non-erosive reflux disease (NERD) has not been reported in the literature. To evaluate the efficacy of rabeprazole 5 mg and 10 mg/day in Japanese NERD patients. The influence of baseline characteristics as well as genetic background on efficacy was also analysed. Subjects were grade M (minimal changes) NERD patients. Two hundred and eighty-eight of these subjects, who were nonresponders to open label antacid therapy, entered in a 4-week, double-blind treatment (placebo, rabeprazole 5 mg or 10 mg/day). Complete heartburn relief rates were 21% in placebo, 34% in rabeprazole 5 mg and 44% in rabeprazole 10 mg (5 mg vs. placebo P = 0.074, 10 mg vs. placebo P = 0.001). Rabeprazole 5 mg was significantly more effective than placebo in elderly patients and in patients with low heartburn frequency or without hiatal hernia. The efficacy of rabeprazole 10 mg was not influenced by age, BMI, hiatal hernia, Helicobacter pylori infection, frequency and severity of heartburn or CYP2C19 genotypes. Rabeprazole 5 mg was effective in a subgroup of Japanese NERD patients. Rabeprazole 10 mg provided more potent heartburn relief than 5 mg and was less fragile to baseline characteristics.Keywords
This publication has 35 references indexed in Scilit:
- Asia‐Pacific consensus on the management of gastroesophageal reflux disease: UpdateJournal of Gastroenterology and Hepatology, 2007
- Validity of endoscopic classification of nonerosive reflux diseaseThe Esophagus, 2007
- Predictors of treatment response in patients with non‐erosive reflux diseaseAlimentary Pharmacology & Therapeutics, 2006
- Minimal changes in reflux esophagitis: red ones and white onesThe Esophagus, 2006
- Efficacy of Rabeprazole in the Treatment of Symptomatic Gastroesophageal Reflux DiseaseDigestive Diseases and Sciences, 2005
- Review article: quality‐of‐life issues in gastro‐oesophageal reflux diseaseAlimentary Pharmacology & Therapeutics, 2005
- Review article: relief of symptoms in gastric acid‐related diseases – correlation with acid suppression in rabeprazole treatmentAlimentary Pharmacology & Therapeutics, 2004
- Oesophageal hypersensitivity in Japanese patients with non‐erosive gastro‐oesophageal reflux diseasesAlimentary Pharmacology & Therapeutics, 2004
- Six‐month trial of on‐demand rabeprazole 10 mg maintains symptom relief in patients with non‐erosive reflux diseaseAlimentary Pharmacology & Therapeutics, 2004
- Review of rabeprazole in the treatment of gastro-oesophageal reflux diseaseExpert Opinion on Pharmacotherapy, 2004