A randomized, double-blind trial of the efficacy and safety of 10 or 20 mg rabeprazole compared with 20 mg omeprazole in the maintenance of gastro-oesophageal reflux disease over 5 years.

2.50
Hdl Handle:
http://hdl.handle.net/2336/4583
Title:
A randomized, double-blind trial of the efficacy and safety of 10 or 20 mg rabeprazole compared with 20 mg omeprazole in the maintenance of gastro-oesophageal reflux disease over 5 years.
Authors:
Thjodleifsson, B; Rindi, G; Fiocca, R; Humphries, T J; Morocutti, A; Miller, N; Bardhan, K D
Citation:
Aliment. Pharmacol. Ther. 2003, 17(3):343-51
Issue Date:
1-Feb-2003
Abstract:
BACKGROUND: Gastro-oesophageal reflux disease has a chronic course, and often requires long-term treatment. Proton pump inhibitors are the treatment of choice for both acute and maintenance treatment, but little is known from randomized controlled trials of their effects beyond 1 year. AIM: To compare the efficacy and safety of two doses of rabeprazole with 20 mg omeprazole in the maintenance treatment of erosive gastro-oesophageal reflux disease over 5 years. METHODS: Two hundred and forty-three patients who had previously responded to acute treatment for erosive gastro-oesophageal reflux disease were prospectively randomized to receive 5 years of treatment with rabeprazole (10 or 20 mg daily) or omeprazole (20 mg daily). The primary outcome measure was endoscopically confirmed relapse of erosive gastro-oesophageal reflux disease. RESULTS: One hundred and twenty-three patients (51%) completed all 5 years of the study, with similar completion rates in the three groups. Relapses occurred in nine of 78 (11.5%), eight of 82 (9.8%) and 11 of 83 (13.3%) patients in the rabeprazole 20 mg, rabeprazole 10 mg and omeprazole 20 mg groups, respectively. Gastric biopsy showed no evidence of any harmful effects. All treatments were well tolerated. CONCLUSIONS: Rabeprazole 10 mg, rabeprazole 20 mg and omeprazole 20 mg all had similar efficacy in the maintenance treatment of gastro-oesophageal reflux disease. All three were safe and well tolerated during 5 years of treatment.
Additional Links:
http://www.blackwell-synergy.com/doi/full/10.1046/j.1365-2036.2003.01446.x

Full metadata record

DC FieldValue Language
dc.contributor.authorThjodleifsson, B-
dc.contributor.authorRindi, G-
dc.contributor.authorFiocca, R-
dc.contributor.authorHumphries, T J-
dc.contributor.authorMorocutti, A-
dc.contributor.authorMiller, N-
dc.contributor.authorBardhan, K D-
dc.date.accessioned2006-09-25T08:54:28Z-
dc.date.available2006-09-25T08:54:28Z-
dc.date.issued2003-02-01-
dc.identifier.citationAliment. Pharmacol. Ther. 2003, 17(3):343-51en
dc.identifier.issn0269-2813-
dc.identifier.pmid12562446-
dc.identifier.doidoi:10.1046/j.1365-2036.2003.01446.x-
dc.identifier.otherGAS12-
dc.identifier.urihttp://hdl.handle.net/2336/4583-
dc.description.abstractBACKGROUND: Gastro-oesophageal reflux disease has a chronic course, and often requires long-term treatment. Proton pump inhibitors are the treatment of choice for both acute and maintenance treatment, but little is known from randomized controlled trials of their effects beyond 1 year. AIM: To compare the efficacy and safety of two doses of rabeprazole with 20 mg omeprazole in the maintenance treatment of erosive gastro-oesophageal reflux disease over 5 years. METHODS: Two hundred and forty-three patients who had previously responded to acute treatment for erosive gastro-oesophageal reflux disease were prospectively randomized to receive 5 years of treatment with rabeprazole (10 or 20 mg daily) or omeprazole (20 mg daily). The primary outcome measure was endoscopically confirmed relapse of erosive gastro-oesophageal reflux disease. RESULTS: One hundred and twenty-three patients (51%) completed all 5 years of the study, with similar completion rates in the three groups. Relapses occurred in nine of 78 (11.5%), eight of 82 (9.8%) and 11 of 83 (13.3%) patients in the rabeprazole 20 mg, rabeprazole 10 mg and omeprazole 20 mg groups, respectively. Gastric biopsy showed no evidence of any harmful effects. All treatments were well tolerated. CONCLUSIONS: Rabeprazole 10 mg, rabeprazole 20 mg and omeprazole 20 mg all had similar efficacy in the maintenance treatment of gastro-oesophageal reflux disease. All three were safe and well tolerated during 5 years of treatment.en
dc.language.isoenen
dc.publisherBlackwell Scientific Publicationsen
dc.relation.urlhttp://www.blackwell-synergy.com/doi/full/10.1046/j.1365-2036.2003.01446.xen
dc.subject.meshBenzimidazolesen
dc.subject.meshAnti-Ulcer Agentsen
dc.subject.meshComparative Studyen
dc.subject.meshDose-Response Relationship, Drugen
dc.subject.meshDouble-Blind Methoden
dc.subject.meshFemaleen
dc.subject.meshGastrinsen
dc.subject.meshGastroesophageal Refluxen
dc.subject.meshHelicobacter Infectionsen
dc.subject.meshHelicobacter pylorien
dc.subject.meshOmeprazoleen
dc.subject.meshProspective Studiesen
dc.subject.meshRecurrenceen
dc.subject.meshResearch Support, Non-U.S. Gov'ten
dc.subject.meshTreatment Outcomeen
dc.titleA randomized, double-blind trial of the efficacy and safety of 10 or 20 mg rabeprazole compared with 20 mg omeprazole in the maintenance of gastro-oesophageal reflux disease over 5 years.en
dc.typeArticleen
dc.identifier.journalAlimentary pharmacology & therapeuticsen
dc.format.digYES-

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