COMPARISON OF RABEPRAZOLE 20 MG VS. OMEPRAZOLE 20 MG IN THE TREATMENTOF ACTIVE GASTRIC-ULCER - A EUROPEAN MULTICENTER STUDY

Background: Rabeprazole sodium is the newest member of a class of subs tituted benzimidazole molecules known as proton pump inhibitors. Other proton pump inhibitors have been shown to be effective in healing act ive, benign gastric ulcers, Methods: In this randomized, double-blind, multicentre study, conducted at 25 European sites, rabeprazole and om eprazole were compared in patients with active gastric ulcers, Two hun dred and twenty-seven patients with active benign gastric ulcer were r andomized to receive either rabeprazole 20 mg (n = 113) or omeprazole 20 mg (n = 114) once daily for 3 or 6 weeks, with healing monitored by endoscopy. Results: After 3 weeks, complete healing (ITT analysis) wa s documented in 58% of patients given rabeprazole and 61% in patients given omeprazole (N.S.). After 6 weeks the healing rates were identica l in both groups at 91%. Rabeprazole-treated patients had numerically greater symptom relief at all 12 points of comparison. The differences significantly favoured rabeprazole at week 3 for daytime pain improve ment (P = 0.023) and at week 6 for pain frequency (P = 0.006) and comp lete resolution of night pain (P = 0.022). Both drugs were well-tolera ted over the 6-week treatment course. Mean changes from baseline to en d-point in fasting serum gastrin were comparable. No significant diffe rences in laboratory parameters were seen. Conclusion: In this study, rabeprazole produced healing rates comparable to omeprazole at weeks 3 and 6, but provided more consistent and occasionally significantly su perior symptom improvement. Both treatments were well-tolerated.