Comparison of rabeprazole 20mg versus omeprazole 20mg in the treatment of active duodenal ulcer: a European multicentre study

Background: Rabeprazole sodium is the newest member of a class of substitut ed benzimidazole molecules known as proton pump inhibitors. Other proton pu mp inhibitors have been shown to be effective in healing active duodenal ul cer. Methods: This randomized, double-blind, multicentre study, conducted at 25 European sites, compared the efficacy and tolerability of rabeprazole and o meprazole in patients with active duodenal ulcers. One hundred and two pati ents with active duodenal ulcer received rabeprazole 20 mg and 103 patients omeprazole 20 mg once daily for 2 or 4 weeks, with ulcer healing monitored by endoscopy. Results: After 2 weeks, complete ulcer healing was documented in 69% of pat ients given rabeprazole 62% of patients given omeprazole 20 mg and in 20 mg (N.S.). After 4 weeks, healing rates were 98% in the rabeprazole group and 93% in the omeprazole group (P = 0.083), Rabeprazole-treated patients had significantly greater improvement in daytime pain symptom relief than those treated with omeprazole at the conclusion of the study (P = 0.038), Both d rugs were well tolerated over the 4-week treatment period. Mean changes fro m baseline to end-point in fasting serum gastrin were significantly greater in the rabeprazole group, but at end-point mean values were well within no rmal limits for both groups. No clinically meaningful changes or other betw een-group differences were observed in laboratory parameters. Conclusion: In this study, rabeprazole produced healing rates equivalent to omeprazole at weeks 2 and 4, and provided significantly greater improvemen t in daytime pain. Both treatments were well tolerated.