title: A randomized, comparative trial of a potassium-competitive acid blocker (AZD0865) and esomeprazole for the treatment of patients with nonerosive reflux disease.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Gastroenterology & Hepatology, Royal Adelaide Hospital, Adelaide, Australia.
authors.forename: John
authors.initials: J
authors.lastname: Dent
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Kahrilas
authors.forename: Jan
authors.initials: J
authors.lastname: Hatlebakk
authors.forename: Nimish
authors.initials: N
authors.lastname: Vakil
authors.forename: Hans
authors.initials: H
authors.lastname: Denison
authors.forename: Stefan
authors.initials: S
authors.lastname: Franzén
authors.forename: Per
authors.initials: P
authors.lastname: Lundborg
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D016099:Endoscopy, Gastrointestinal; D004791:Enzyme Inhibitors / Q000008:administration & dosage*; D064098:Esomeprazole / Q000008:administration & dosage*; D004947:Esophagus / Q000378:metabolism / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; D005745:Gastric Acidity Determination; D005764:Gastroesophageal Reflux / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D006356:Heartburn / Q000175:diagnosis / Q000188:drug therapy / Q000209:etiology; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007093:Imidazoles / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011725:Pyridines / Q000008:administration & dosage*; D012189:Retrospective Studies; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: C514958:AZD0865; D004791:Enzyme Inhibitors; D007093:Imidazoles; D011725:Pyridines; D064098:Esomeprazole