Efficacy of esomeprazole compared with omeprazole in reflux esophagitis patients -A phase III, multicenter, randomized, double-blind, parallel-group trial-

Abstract

Efficacy of esomeprazole 40mg/day (E40) and 20mg/day (E20) as initial treatment for reflux esophagitis (RE) was compared with omeprazole 20mg/day (O20) in this multicenter, prospective, randomized, double-blind study. Healing rates at week 8 (primary endpoint) were 90.0% (171/190), 87.3% (165/189), and 87.4% (166/190) for the E40, E20, and O20 groups, respectively, confirming the non-inferiority of E40 and E20 to O20. Drug-related adverse events were reported in 4.2%, 7.9%, and 8.4% of patients in the E40, E20 and O20 groups, respectively, but none of these events were serious. Initial treatment of esomeprazole for RE was generally well tolerated, confirming the non-inferiority effect with omeprazole.