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Double-blind comparison [correction of Double-blind, placebo-controlled comparison] of rabeprazole 20 mg vs. omeprazole 20 mg in the treatment of erosive or ulcerative gastro-oesophageal reflux disease. The European Rabeprazole Study Group.
Aliment Pharmacol Ther. 1999 Jan; 13(1):49-57.AP

Abstract

BACKGROUND

Rabeprazole sodium is the most recent 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 oesophagitis.

METHODS

In this randomised, double-blind, multicentre study, conducted at 27 European sites, the efficacy and safety of rabeprazole and omeprazole were compared in patients with erosive or ulcerative gastro-oesophageal reflux 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 endoscopy.

RESULTS

Overall GERD healing rates observed and evaluated at weeks 4 and 8 were equivalent. Four-week healing rates for rabeprazole and omeprazole were 81%-81% and 92%-94% for 8-week healing. Rabeprazole-treated patients had similar relief of the frequency and intensity of heartburn to those treated with omeprazole. Both drugs were well tolerated over the 8-week treatment period. Mean changes in fasting serum gastrin were comparable. No significant differences in laboratory parameters were seen. Biopsies for argyrophil ECL cell histology at the end-point revealed a similar distributions of hyperplasia grades to those at baseline in both groups. Biopsies of body and antral mucosa for other parameters were similar between treatments for Helicobacter pylori colonization, presence or degree of inflammation, atrophy or intestinal metaplasia at the end-point.

CONCLUSION

In this study, GERD healing rates following rabeprazole 20 mg once daily were equivalent to those obtained with omeprazole 20 mg once daily. Both treatments resulted in a comparable relief of the frequency and intensity of heartburn associated with this disease, and both were well tolerated.

Authors+Show Affiliations

Ignatius Hospital, Breda, The Netherlands.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

9892879

Citation

Dekkers, C P., et al. "Double-blind Comparison [correction of Double-blind, Placebo-controlled Comparison] of Rabeprazole 20 Mg Vs. Omeprazole 20 Mg in the Treatment of Erosive or Ulcerative Gastro-oesophageal Reflux Disease. the European Rabeprazole Study Group." Alimentary Pharmacology & Therapeutics, vol. 13, no. 1, 1999, pp. 49-57.
Dekkers CP, Beker JA, Thjodleifsson B, et al. Double-blind comparison [correction of Double-blind, placebo-controlled comparison] of rabeprazole 20 mg vs. omeprazole 20 mg in the treatment of erosive or ulcerative gastro-oesophageal reflux disease. The European Rabeprazole Study Group. Aliment Pharmacol Ther. 1999;13(1):49-57.
Dekkers, C. P., Beker, J. A., Thjodleifsson, B., Gabryelewicz, A., Bell, N. E., & Humphries, T. J. (1999). Double-blind comparison [correction of Double-blind, placebo-controlled comparison] of rabeprazole 20 mg vs. omeprazole 20 mg in the treatment of erosive or ulcerative gastro-oesophageal reflux disease. The European Rabeprazole Study Group. Alimentary Pharmacology & Therapeutics, 13(1), 49-57.
Dekkers CP, et al. Double-blind Comparison [correction of Double-blind, Placebo-controlled Comparison] of Rabeprazole 20 Mg Vs. Omeprazole 20 Mg in the Treatment of Erosive or Ulcerative Gastro-oesophageal Reflux Disease. the European Rabeprazole Study Group. Aliment Pharmacol Ther. 1999;13(1):49-57. PubMed PMID: 9892879.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Double-blind comparison [correction of Double-blind, placebo-controlled comparison] of rabeprazole 20 mg vs. omeprazole 20 mg in the treatment of erosive or ulcerative gastro-oesophageal reflux disease. The European Rabeprazole Study Group. AU - Dekkers,C P, AU - Beker,J A, AU - Thjodleifsson,B, AU - Gabryelewicz,A, AU - Bell,N E, AU - Humphries,T J, PY - 1999/1/20/pubmed PY - 1999/1/20/medline PY - 1999/1/20/entrez SP - 49 EP - 57 JF - Alimentary pharmacology & therapeutics JO - Aliment Pharmacol Ther VL - 13 IS - 1 N2 - BACKGROUND: Rabeprazole sodium is the most recent 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 oesophagitis. METHODS: In this randomised, double-blind, multicentre study, conducted at 27 European sites, the efficacy and safety of rabeprazole and omeprazole were compared in patients with erosive or ulcerative gastro-oesophageal reflux 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 endoscopy. RESULTS: Overall GERD healing rates observed and evaluated at weeks 4 and 8 were equivalent. Four-week healing rates for rabeprazole and omeprazole were 81%-81% and 92%-94% for 8-week healing. Rabeprazole-treated patients had similar relief of the frequency and intensity of heartburn to those treated with omeprazole. Both drugs were well tolerated over the 8-week treatment period. Mean changes in fasting serum gastrin were comparable. No significant differences in laboratory parameters were seen. Biopsies for argyrophil ECL cell histology at the end-point revealed a similar distributions of hyperplasia grades to those at baseline in both groups. Biopsies of body and antral mucosa for other parameters were similar between treatments for Helicobacter pylori colonization, presence or degree of inflammation, atrophy or intestinal metaplasia at the end-point. CONCLUSION: In this study, GERD healing rates following rabeprazole 20 mg once daily were equivalent to those obtained with omeprazole 20 mg once daily. Both treatments resulted in a comparable relief of the frequency and intensity of heartburn associated with this disease, and both were well tolerated. SN - 0269-2813 UR - https://www.unboundmedicine.com/medline/citation/9892879/Double_blind_comparison_[correction_of_Double_blind_placebo_controlled_comparison]_of_rabeprazole_20_mg_vs__omeprazole_20_mg_in_the_treatment_of_erosive_or_ulcerative_gastro_oesophageal_reflux_disease__The_European_Rabeprazole_Study_Group_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=0269-2813&date=1999&volume=13&issue=1&spage=49 DB - PRIME DP - Unbound Medicine ER -