[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: Yoshikazu Kinoshita, Hiroto Miwa, Kunio Kasugai
• Journal: Nihon Shokakibyo Gakkai zasshi = The Japanese journal of gastro-enterology (Nihon Shokakibyo Gakkai Zasshi) Vol. 110 Issue 8 Pg. 1428-38 (Aug 2013) ISSN: 0446-6586 [Print] Japan
• PMID: 23912002 (Publication Type: Clinical Trial, Phase III, Comparative Study, English Abstract, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Proton Pump Inhibitors
• Omeprazole
• Esomeprazole

Topics

• Aged
• Double-Blind Method
• Esomeprazole (adverse effects, therapeutic use)
• Esophagitis, Peptic (drug therapy)
• Female
• Humans
• Male
• Middle Aged
• Omeprazole (adverse effects, therapeutic use)
• Proton Pump Inhibitors (adverse effects, therapeutic use)