[Efficacy and safety of esomeprazole, compared with omeprazole, in maintenance
therapy for reflux esophagitis -a phase III, multicenter, randomized,
double-blind trial-]. [Article in Japanese]
Author(s): Kinoshita Y(1), Miwa H, Kasugai K.
Affiliation(s): Author information:
(1)Second Department of Internal Medicine, Shimane University School of Medicine,
Japan. kinosita@med.shimane-u.ac.jp
Publication date & source: 2013, Nihon Shokakibyo Gakkai Zasshi. , 110(8):1428-38
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.
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