Double-blind, placebo-controlled comparison of rabeprazole 20 mg vs. omeprazole 20 mg in the treatment of erosive or ulcerative gastro-oesophageal reflux disease

Background: Rabeprazole sodium is the most recent member of a class of subs tituted benzimidazole molecules known as proton pump inhibitors. Other prot on pump inhibitors have been shown to be effective in healing oesophagitis. Methods: In this randomised, double-blind, multicentre study, conducted at 27 European sites, the efficacy and safety of rabeprazole and omeprazole we re compared in patients with erosive or ulcerative gastro-oesophageal reflu x disease (GERD).100 patients received rabeprazole 20 mg, and 102 patients omeprazole 20 mg once daily for 4 or 8 weeks, with healing monitored by end oscopy. Results: Overall GERD healing rates observed and evaluated at weeks 4 and 8 were equivalent. Four-week healing rates for rabeprazole and omeprazole we re 81%-81% and 92%-94% for 8-week healing. Rabeprazole-treated patients had similar relief of the frequency and intensity of heartburn to those treate d with omeprazole. Both drugs were well tolerated over the 8-week treatment period, Mean changes in fasting serum gastrin were comparable, No signific ant differences in laboratory parameters were seen. Biopsies for argyrophil ECL cell histology at the end-point revealed a similar distributions of hy perplasia grades to those at baseline in both groups. Biopsies of body and antral mucosa for other parameters were similar between treatments for Heli cobactcr pylori colonization, presence or degree of inflammation, atrophy o r intestinal metaplasia at the end-point. Conclusion: In this study, GERD healing rates following rabeprazole 20 mg o nce daily were equivalent to those obtained with omeprazole 20 mg once dail y. Both treatments resulted in a comparable relief of the frequency and int ensity of heartburn associated with this disease, and both were well tolera ted.