title: A multicenter, randomized, double-blind, 8-week comparative trial of low-dose esomeprazole (20 mg) and standard-dose omeprazole (20 mg) in patients with erosive esophagitis.
abstract: The objective of this trial was to compare the efficacy of esomeprazole, 20 mg, with that of omeprazole, 20 mg, in patients with erosive esophagitis (EE). In this multicenter, double-blind, parallel-group trial, 1176 patients with EE confirmed by endoscopy (Helicobacter pylori-negative by serology) were randomized to once-daily treatment with 20 mg esomeprazole or 20 mg omeprazole for 8 weeks. The primary outcome was the proportion of patients with healed EE through week 8. Secondary outcomes included diary and investigator assessments of heartburn symptoms. Cumulative life-table healing rates at week 8 were similarly high for 20 mg esomeprazole (90.6%; 95% confidence interval, 88.1%-93%) and 20 mg omeprazole (88.3%; 95% confidence interval, 85.5%-91.0%). The two treatments were comparable for other secondary measures and had similar tolerability profiles.
authors.affiliation: Columbia-Presbyterian Medical Center, Harkness Pavillion, 7th Floor, Room 712, New York, New York 10032, USA. cjl18@columbia.edu
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Lightdale
authors.forename: Colleen
authors.initials: C
authors.lastname: Schmitt
authors.forename: Clara
authors.initials: C
authors.lastname: Hwang
authors.forename: Bernard
authors.initials: B
authors.lastname: Hamelin
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D064098:Esomeprazole; D004942:Esophagitis, Peptic / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000897:Anti-Ulcer Agents; D009853:Omeprazole; D064098:Esomeprazole