Comparison of rabeprazole 20 mg vs. omeprazole 20 mg in the treatment of active gastric ulcer-a European multicentre study

Autor:	B. Thjodleifsson, C. P. M. Dekkers, J. A. Beker, T. J. Humphries, A. Gabryelewicz, N. E. Bell
Rok vydání:	1998
Předmět:	Chemotherapy medicine.medical_specialty Hepatology business.industry medicine.drug_class medicine.medical_treatment Stomach Gastroenterology Rabeprazole Proton-pump inhibitor law.invention Clinical trial medicine.anatomical_structure Randomized controlled trial law Internal medicine Medicine Pharmacology (medical) Rabeprazole Sodium business Omeprazole medicine.drug
Zdroj:	Alimentary Pharmacology & Therapeutics. 12:789-795
ISSN:	0269-2813
DOI:	10.1046/j.1365-2036.1998.00373.x
Popis:	Background: Rabeprazole sodium is the newest member of a class of substituted benzimidazole molecules known as proton pump inhibitors. Other proton pump inhibitors have been shown to be effective in healing active, benign gastric ulcers. Methods: In this randomized, double-blind, multicentre study, conducted at 25 European sites, rabeprazole and omeprazole were compared in patients with active gastric ulcers. Two hundred and twenty-seven patients with active benign gastric ulcer were randomized 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) was documented in 58% of patients given rabeprazole and 61% in patients given omeprazole (N.S.). After 6 weeks the healing rates were identical 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 improvement (P = 0.023) and at week 6 for pain frequency (P = 0.006) and complete resolution of night pain (P = 0.022). Both drugs were well-tolerated over the 6-week treatment course. Mean changes from baseline to end-point in fasting serum gastrin were comparable. No significant differences 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 superior symptom improvement. Both treatments were well-tolerated.
Databáze:	OpenAIRE
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