title: Esomeprazole treatment of frequent heartburn: two randomized, double-blind, placebo-controlled trials.
abstract: OBJECTIVE
  To determine the efficacy of a 14-day regimen of esomeprazole 20 mg for the treatment of frequent heartburn in subjects who are likely to self-treat with over-the-counter medications without consulting a health care provider.
  
  
  METHODS
  Adults with frequent heartburn ≥ 2 days per week in the past 4 weeks were randomly assigned to 14-day double-blind treatment with esomeprazole 20 mg once daily or placebo in 2 identical multicenter studies (ClinicalTrials.gov identifiers: NCT01370525, NCT01370538). The primary efficacy outcome was percentage of heartburn-free 24-hour days across 14 days. Secondary efficacy outcomes included heartburn resolution, defined as heartburn ≤ 2 days over 14 days, and percentages of subjects reporting ≤ 1 day with heartburn in the first and final weeks of treatment. Subjects recorded data in daily self-assessment diaries.
  
  
  RESULTS
  The percentage of heartburn-free 24-hour days over 14 days was significantly higher (P < 0.0001) in subjects receiving esomeprazole 20 mg compared with placebo in study 1 (N = 331; 46.13% vs. 33.07%, respectively) and study 2 (N = 320; 48.00% vs 32.75%, respectively). Significantly more subjects treated with esomeprazole 20 mg had heartburn resolution over 14 days and in the first and final weeks compared with placebo. Within the first 4 days, the proportion of subjects with heartburn-free days was significantly greater with esomeprazole 20 mg versus placebo. Treatment was generally well tolerated, with a safety pattern consistent with the known profile for esomeprazole.
  
  
  CONCLUSIONS
  A 14-day regimen of esomeprazole 20 mg once daily was effective for treating frequent heartburn in subjects who are likely to self-treat with over-the-counter medications.
authors.affiliation: Emeritus Professor, University of Virginia School of Medicine, Charlottesville, VA. dap8v@virginia.edu.
authors.forename: David A
authors.initials: DA
authors.lastname: Peura
authors.forename: Barry
authors.initials: B
authors.lastname: Traxler
authors.forename: Christopher
authors.initials: C
authors.lastname: Kocun
authors.forename: Tore
authors.initials: T
authors.lastname: Lind
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D064098:Esomeprazole / Q000008:administration & dosage*; D005260:Female; D006356:Heartburn / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D004366:Nonprescription Drugs; D054328:Proton Pump Inhibitors / Q000008:administration & dosage*; D012651:Self Medication; D016896:Treatment Outcome
chemical_list: D004366:Nonprescription Drugs; D054328:Proton Pump Inhibitors; D064098:Esomeprazole