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A Randomized, Comparative Trial of a Potassium-Competitive Acid Blocker (AZD0865) and Esomeprazole for the Treatment of Patients With Nonerosive Reflux Disease

Dent, John, M.D.1; Kahrilas, Peter J., M.D.2; Hatlebakk, Jan, M.D.3; Vakil, Nimish, M.D., F.A.C.P., F.A.C.G.4; Denison, Hans, M.D.5; Franzén, Stefan, Ph.D.5; Lundborg, Per, M.D.5

American Journal of Gastroenterology: January 2008 - Volume 103 - Issue 1 - p 20–26
ORIGINAL CONTRIBUTIONS: ESOPHAGUS
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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.

1Department of Gastroenterology & Hepatology, Royal Adelaide Hospital, Adelaide, Australia; 2Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois; 3Institute of Medicine, Haukeland University Hospital, University of Bergen, Bergen, Norway; 4University of Wisconsin Medical School, Madison, Wisconsin; and 5AstraZeneca Research & Development, Mölndal, Sweden

Reprint requests and correspondence: John Dent, M.D., Department of Gastroenterology & Hepatology, Royal Adelaide Hospital, Adelaide, Australia.

Received April 2, 2007; accepted July 31, 2007.

CONFLICT OF INTERESTGuarantor of the article: John Dent, M.D.

Specific author contributions: John Dent and Peter Kahrilas were involved in planning and overseeing the trial, contributed to data interpretation and the primary drafting and finalization of the manuscript. Jan Hatlebakk headed one of the study centers, contributed to data interpretation and review and finalization of the manuscript. Nimish Vakil contributed to the study design, interpretation of the data, and review and finalization of the manuscript. Hans Denison helped plan the study and to develop the detailed study protocol. He contributed to surveillance and interpretation of the study data, and review and finalization of the manuscript. Stefan Franzén helped plan the study and to develop the detailed study protocol and performed statistical analyses. He also was involved in data interpretation and review and finalization of the manuscript. Per Lundborg was involved in study surveillance, interpretation of data, and review and finalization of the manuscript.

Financial support: John Dent is a paid consultant to AstraZeneca and recipient of research support in the field of gastroesophageal reflux disease. Peter Kahrilas is a paid consultant to AstraZeneca. Jan Hatlebakk is a consultant for Wyeth, AstraZeneca, Medtronic, and Takeda and receives funding from these companies. Nimish Vakil serves as a paid consultant to AstraZeneca, TAP Pharmaceuticals, Proctor and Gamble, and Eisai-Janssen, and has received research funding from Altana. Hans Denison, Stefan Franzén, and Per Lundborg are full-time employees of AstraZeneca.

Potential competing interests: None.

© The American College of Gastroenterology 2008. All Rights Reserved.
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