Randomized, double-blind, comparative study of dexrabeprazole 10 mg versus rabeprazole 20 mg in the treatment of gastroesophageal reflux disease

Abstract

Aim: To compare the efficacy and safety of dexrabeprazole 10 mg versus rabeprazole 20 mg in the treatment of gastroesophageal reflux disease (GERD).

Methods: This was a randomized, double-blind clinical study. Fifty patients with GERD were randomly assigned to receive dexrabeprazole 10 mg or rabeprazole 20 mg once daily. Efficacy was assessed by evaluating improvement in visual analog scale (VAS) scores of heart-burn and regurgitation and safety was assessed by recording incidence of any adverse drug reactions. Laboratory investigations and upper gastro-intestinal endoscopy was conducted at baseline and after 28 d of therapy.

Results: A total of 50 patients (n = 25 in dexrabeprazole group and rabeprazole group each) completed the study. There were no significant differences in the baseline characteristics between the two groups. The VAS score (mean +/- SD) of heartburn and regurgitation in dexrabeprazole (64.8 +/- 5.1 and 64 +/- 8.1, respectively) and rabeprazole (64.4 +/- 8.7 and 57.6 +/- 9.7, respectively) groups significantly reduced (P < 0.0001) to 30 +/- 11.5, 24 +/- 10 and 32 +/- 9.5, 29.2 +/- 11.9, respectively on d 28. A significantly higher (P = 0.002) proportion of patients showed >or= 50% improvement in regurgitation with dexrabeprazole 10 mg (96%) compared to rabeprazole 20 mg (60%). Onset of symptom improvement was significantly earlier with dexrabeprazole than with rabeprazole (1.8 +/- 0.8 d vs 2.6 +/- 1.4 d; P < 0.05). The incidences of esophagitis in the dexrabeprazole group and rabeprazole group before therapy were 84% and 92%, respectively (P = 0.38). The incidence of improvement/healing of esophagitis after therapy was more (P = 0.036) in the dexrabeprazole group (95.2%) compared to the rabeprazole group (65.2%). No adverse drug reaction was seen in either group.

Conclusion: In the treatment of GERD, efficacy of dexrabeprazole 10 mg is better than rabeprazole 20 mg, with regards to improvement/healing of endoscopic lesions and relief from symptoms of regurgitation.