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A randomized, double-blind, comparative study of standard-dose rabeprazole and high-dose omeprazole in gastro-oesophageal reflux disease.
Aliment Pharmacol Ther. 2002 Mar; 16(3):479-85.AP

Abstract

BACKGROUND

Rabeprazole has a faster onset of antisecretory action than omeprazole, and it is of interest to determine whether this translates into faster symptom relief in patients with gastro-oesophageal reflux disease.

AIMS

To assess the relief from heartburn after 3 days of treatment with standard-dose rabeprazole or high-dose omeprazole (primary end-point). Secondary end-points included the decrease in score for other symptoms of gastro-oesophageal reflux disease, healing rates and quantification of antacid use.

METHODS

Patients with endoscopically confirmed erosive oesophagitis were randomized to receive 4 weeks of double-blind treatment with rabeprazole (20 mg) or omeprazole (40 mg). Patients who were not healed after 4 weeks received a further 4 weeks of treatment.

RESULTS

Two hundred and seventy-four patients were screened, 251 patients were randomized and 230 patients completed the trial. The numbers of patients with relief from heartburn on day 4 were similar in the two groups (84% for rabeprazole; 95% confidence interval, 76-90%; 83% for omeprazole; 95% confidence interval, 75-89%). There were no significant differences between the treatments in the relief from other gastro-oesophageal reflux disease symptoms or in healing rates. The number of reports of severe heartburn during the first 3 days was higher in the omeprazole group (daytime heartburn: 4.7% for rabeprazole vs. 10.3% for omeprazole, P=0.005; night-time heartburn: 4.7% for rabeprazole vs. 9.8% for omeprazole, P=0.01; statistical comparisons defined post hoc).

CONCLUSIONS

Standard-dose rabeprazole was as effective as high-dose omeprazole in relieving symptoms by day 4 of treatment and in healing oesophageal lesions, but had a faster onset of action in patients with severe heartburn. This suggests that the improved pharmacological properties of rabeprazole translate into a clinically relevant advantage.

Authors+Show Affiliations

Department of Gastroenterology and Hepatology, University of Essen, Essen, Germany. g.holtmann@uni-essen.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11876701

Citation

Holtmann, G, et al. "A Randomized, Double-blind, Comparative Study of Standard-dose Rabeprazole and High-dose Omeprazole in Gastro-oesophageal Reflux Disease." Alimentary Pharmacology & Therapeutics, vol. 16, no. 3, 2002, pp. 479-85.
Holtmann G, Bytzer P, Metz M, et al. A randomized, double-blind, comparative study of standard-dose rabeprazole and high-dose omeprazole in gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2002;16(3):479-85.
Holtmann, G., Bytzer, P., Metz, M., Loeffler, V., & Blum, A. L. (2002). A randomized, double-blind, comparative study of standard-dose rabeprazole and high-dose omeprazole in gastro-oesophageal reflux disease. Alimentary Pharmacology & Therapeutics, 16(3), 479-85.
Holtmann G, et al. A Randomized, Double-blind, Comparative Study of Standard-dose Rabeprazole and High-dose Omeprazole in Gastro-oesophageal Reflux Disease. Aliment Pharmacol Ther. 2002;16(3):479-85. PubMed PMID: 11876701.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, double-blind, comparative study of standard-dose rabeprazole and high-dose omeprazole in gastro-oesophageal reflux disease. AU - Holtmann,G, AU - Bytzer,P, AU - Metz,M, AU - Loeffler,V, AU - Blum,A L, PY - 2002/3/6/pubmed PY - 2002/6/5/medline PY - 2002/3/6/entrez SP - 479 EP - 85 JF - Alimentary pharmacology & therapeutics JO - Aliment Pharmacol Ther VL - 16 IS - 3 N2 - BACKGROUND: Rabeprazole has a faster onset of antisecretory action than omeprazole, and it is of interest to determine whether this translates into faster symptom relief in patients with gastro-oesophageal reflux disease. AIMS: To assess the relief from heartburn after 3 days of treatment with standard-dose rabeprazole or high-dose omeprazole (primary end-point). Secondary end-points included the decrease in score for other symptoms of gastro-oesophageal reflux disease, healing rates and quantification of antacid use. METHODS: Patients with endoscopically confirmed erosive oesophagitis were randomized to receive 4 weeks of double-blind treatment with rabeprazole (20 mg) or omeprazole (40 mg). Patients who were not healed after 4 weeks received a further 4 weeks of treatment. RESULTS: Two hundred and seventy-four patients were screened, 251 patients were randomized and 230 patients completed the trial. The numbers of patients with relief from heartburn on day 4 were similar in the two groups (84% for rabeprazole; 95% confidence interval, 76-90%; 83% for omeprazole; 95% confidence interval, 75-89%). There were no significant differences between the treatments in the relief from other gastro-oesophageal reflux disease symptoms or in healing rates. The number of reports of severe heartburn during the first 3 days was higher in the omeprazole group (daytime heartburn: 4.7% for rabeprazole vs. 10.3% for omeprazole, P=0.005; night-time heartburn: 4.7% for rabeprazole vs. 9.8% for omeprazole, P=0.01; statistical comparisons defined post hoc). CONCLUSIONS: Standard-dose rabeprazole was as effective as high-dose omeprazole in relieving symptoms by day 4 of treatment and in healing oesophageal lesions, but had a faster onset of action in patients with severe heartburn. This suggests that the improved pharmacological properties of rabeprazole translate into a clinically relevant advantage. SN - 0269-2813 UR - https://www.unboundmedicine.com/medline/citation/11876701/A_randomized_double_blind_comparative_study_of_standard_dose_rabeprazole_and_high_dose_omeprazole_in_gastro_oesophageal_reflux_disease_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=0269-2813&date=2002&volume=16&issue=3&spage=479 DB - PRIME DP - Unbound Medicine ER -