Biomaterial Database

[Efficacy and safety of esomeprazole, compared with omeprazole, in maintenance therapy for reflux esophagitis -a phase III, multicenter, randomized, double-blind trial-]. 2013

Yoshikazu Kinoshita, and Hiroto Miwa, and Kunio Kasugai

Second Department of Internal Medicine, Shimane University School of Medicine, Japan. kinosita@med.shimane-u.ac.jp

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.

UI	MeSH Term	Description	Entries
D008297	Male		Males
D008875	Middle Aged	An adult aged 45 - 64 years.	Middle Age
D009853	Omeprazole	A 4-methoxy-3,5-dimethylpyridyl, 5-methoxybenzimidazole derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits an H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.	H 168-68,Omeprazole Magnesium,Omeprazole Sodium,Prilosec,H 168 68,H 16868,Magnesium, Omeprazole,Sodium, Omeprazole
D004311	Double-Blind Method	A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.	Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D004942	Esophagitis, Peptic	INFLAMMATION of the ESOPHAGUS that is caused by the reflux of GASTRIC JUICE with contents of the STOMACH and DUODENUM.	Esophagitis, Reflux,Esophagitides, Peptic,Esophagitides, Reflux,Peptic Esophagitides,Peptic Esophagitis,Reflux Esophagitides,Reflux Esophagitis
D005260	Female		Females
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000368	Aged	A person 65 years of age or older. For a person older than 79 years, AGED, 80 AND OVER is available.	Elderly
D054328	Proton Pump Inhibitors	Compounds that inhibit H(+)-K(+)-EXCHANGING ATPASE. They are used as ANTI-ULCER AGENTS and sometimes in place of HISTAMINE H2 ANTAGONISTS for GASTROESOPHAGEAL REFLUX.	Proton Pump Inhibitor,Inhibitor, Proton Pump,Inhibitors, Proton Pump,Pump Inhibitor, Proton
D064098	Esomeprazole	The S-isomer of omeprazole.	Esomeprazole Magnesium,Esomeprazole Potassium,Esomeprazole Sodium,Esomeprazole Strontium,Esomeprazole Strontium Anhydrous,Nexium,Strontium, Esomeprazole