Esomeprazole treatment of frequent heartburn: two randomized, double-blind, placebo-controlled trials.

Abstract

PURPOSE:

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.

CONCLUSION:

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: David A Peura, Barry Traxler, Christopher Kocun, Tore Lind
• Journal: Postgraduate medicine (Postgrad Med) Vol. 126 Issue 4 Pg. 33-41 (Jul 2014) ISSN: 1941-9260 [Electronic] England
• PMID: 25141241 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Nonprescription Drugs
• Proton Pump Inhibitors
• Esomeprazole

Topics

• Adult
• Double-Blind Method
• Esomeprazole (administration & dosage)
• Female
• Heartburn (drug therapy)
• Humans
• Male
• Middle Aged
• Nonprescription Drugs
• Proton Pump Inhibitors (administration & dosage)
• Self Medication
• Treatment Outcome