Please use this identifier to cite or link to this item: http://hdl.handle.net/2440/50867
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Type: Journal article
Title: A randomized, comparative trial of a potassium-competitive acid blocker (AZD0865) and esomeprazole for the treatment of patients with nonerosive reflux disease
Author: Dent, J.
Kahrilas, P.
Hatlebakk, J.
Vakil, N.
Denison, H.
Franzen, S.
Lundborg, P.
Citation: American Journal of Gastroenterology, 2008; 2008(1):20-26
Publisher: Blackwell Publishing Ltd
Issue Date: 2008
ISSN: 0002-9270
1572-0241
Statement of
Responsibility: 
John Dent, Peter J. Kahrilas, Jan Hatlebakk, Nimish Vakil, Hans Denison, Stefan Franzén and Per Lundborg
Abstract: OBJECTIVES: AZD0865 is a gastric acid-suppressing agent that has a rapid onset of action and long duration of effect. This double-blind, randomized, multicenter study investigated the efficacy and safety of AZD0865 in the treatment of patients with nonerosive reflux disease (NERD). METHODS: Patients with troublesome heartburn for at least 6 months and no evidence of erosions at endoscopy were randomized to receive AZD0865 (25, 50, or 75 mg/day) or esomeprazole 20 mg/day, for 4 wk. Throughout the treatment period, patients reported the presence and intensity of heartburn and other NERD symptoms twice daily using an electronic diary. Twenty-four-hour ambulatory intraesophageal/intragastric pH monitoring was performed in a subset of patients on day 14. RESULTS: A total of 1,469 patients were randomized. The median time to sustained absence of heartburn (for 7 consecutive days) was approximately 12 days for all treatment groups and did not differ significantly for any of the AZD0865 doses or compared with esomeprazole. There were no significant differences among treatment groups in the cumulative incidence of sustained absence of heartburn during 4 wk treatment (i.e., 65-70%). The percentage of time for which intragastric pH was greater than 4 was significantly greater for AZD0865 75 mg/day compared with esomeprazole 20 mg (75% vs 60%, P < 0.05). AZD0865 was generally well tolerated although reversible elevations of liver transaminases occurred in some patients receiving the agent. CONCLUSIONS: AZD0865 did not provide clinical benefit over esomeprazole 20 mg in the management of patients with NERD.
Keywords: Esophagus; Humans; Gastroesophageal Reflux; Heartburn; Imidazoles; Pyridines; Enzyme Inhibitors; Endoscopy, Gastrointestinal; Gastric Acidity Determination; Treatment Outcome; Administration, Oral; Severity of Illness Index; Questionnaires; Retrospective Studies; Follow-Up Studies; Double-Blind Method; Dose-Response Relationship, Drug; Hydrogen-Ion Concentration; Adolescent; Adult; Aged; Middle Aged; Female; Male; Esomeprazole Sodium
Description: © 2008 by Am. Coll. of Gastroenterology
RMID: 0020084840
DOI: 10.1111/j.1572-0241.2007.01544.x
Appears in Collections:Medicine publications

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