title: [Efficacy and safety of esomeprazole, compared with omeprazole, in maintenance therapy for reflux esophagitis -a phase III, multicenter, randomized, double-blind trial-].
abstract: A multicenter, randomized, double-blind study comparing the efficacy and safety of esomeprazole 20mg/day (E20) and 10mg/day (E10) with omeprazole 10mg/day (O10) for maintenance of remission in patients with healed reflux esophagitis (RE). For RE, at week 24, the estimated Kaplan-Meier recurrence-free rates were 92.0%, 87.5%, and 82.7% in the E20, E10, and O10 groups, respectively. There was a statistically significant difference between the E20 and O10 groups (p=0.007). Drug-related adverse events tended to be mild but were reported at rates of 9.0%, 8.0%, and 5.3% in the E20, E10, and O10 groups, respectively. Compared with omeprazole, maintenance therapy with 20mg esomeprazole was generally well tolerated and effective for RE.
authors.affiliation: Second Department of Internal Medicine, Shimane University School of Medicine, Japan. kinosita@med.shimane-u.ac.jp
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Kinoshita
authors.forename: Hiroto
authors.initials: H
authors.lastname: Miwa
authors.forename: Kunio
authors.initials: K
authors.lastname: Kasugai
mesh_terms: D000368:Aged; D004311:Double-Blind Method; D064098:Esomeprazole / Q000009:adverse effects / Q000627:therapeutic use*; D004942:Esophagitis, Peptic / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000009:adverse effects / Q000627:therapeutic use*; D054328:Proton Pump Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D054328:Proton Pump Inhibitors; D009853:Omeprazole; D064098:Esomeprazole