Mo1069 Effect of Oral Administration of a New Proton Pump Inhibitor E3710 on 24-h Intra-Gastric pH in Japanese Subjects

Abstract

Background and Aims: Due to recurring nature of GERD, Most patients require long term maintenance therapy and continuous medication of proton pump inhibitor (PPI) is an adequate option for patients with erosive esophagitis. The aim of this study was to evaluate the efficacy and cost minimization analysis of omeprazole 10 mg once daily and rabeprazole 10 mg once daily for 24 weeks in the maintenance of remission Methods:This is randomized, open-label study enrolled 279 patients with erosive esophagitis A or B (LA classification) and typical GERD symptoms. Patients who showed complete endoscopic and symptomatic healing after 8 weeks PPI treatment were randomly allocated to maintenance treatment with omeprazole 10mg once daily or rabeprazole 10mg once daily for 42 weeks. The primary efficacy endpoint was the proportion of patients with symptomatic remission at 42 weeks. Secondary assessments included healing of reflux esophagitis, severity and frequency of reflux symptoms and cost-minimization analysis in the maintenance phase Results:At the end of 42 weeks of maintenance therapy, 96.4% of omeprazole treated and 95.1% of rabeprazole treated patients remained symptom free (P>0.05). Omeprazole and rabeprazole were also similarly efficacious in terms of endoscopic non-relapse rate for RE with 93.3% of patients on omeprazole and 97.5% of patients of rabeprazle. (P>0.05) Two drugs were also comparable with regard to severity and frequency of reflux symptoms duringmaintenance phase. (P>0.05) In the cost-minimization analysis, The mean total costs per patient for remaining symptom free within 6 months was 241,775 won in omeprazole and 287,115 won in rabeprazole, respectively.(as if 24 November 2011, 1 USD= 1,176.33 won) Conclusions:Omeprazole 10mg appeared to have a similar efficacy in maintaining symptomatic remission as rabeprazole 10 mg, but had a lower total cost per patient than rabeprazole 10mg.