IngentaConnect A randomized, double-blind trial of the efficacy and safety of 10...

Authors: Thjodleifsson, B.¹; Rindi, G.²; Fiocca, R.³; Humphries, T. J.⁴; Morocutti, A.⁴; Miller, N.⁴; Bardhan, K. D.⁵

Source: Alimentary Pharmacology & Therapeutics, Volume 17, Number 3, February 2003 , pp. 343-351(9)

Publisher: Blackwell Publishing

Abstract:

Summary 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.

Document Type: Research article

DOI: 10.1046/j.1365-2036.2003.01446.x

Affiliations: 1: University Hospital, Reykjavik, Iceland; 2: University of Parma, Parma, Italy; 3: Department of Pathology, University of Genoa, Genoa, Italy; 4: Eisai Limited, London, UK; 5: Rotherham General Hospitals NHS Trust, Rotherham, UK

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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