Acid-suppressive therapy with esomeprazole for relief of unexplained chest pain in primary care: a randomized, double-blind, placebo-controlled trial.

Abstract

OBJECTIVES:

High-quality data regarding the efficacy of acid-suppressive treatment for unexplained chest pain are lacking. The aim of this study was to evaluate the efficacy of esomeprazole in primary-care treatment of patients with unexplained chest pain stratified for frequency of reflux/regurgitation symptoms.

METHODS:

Patients with a ≥ 2-week history of unexplained chest pain (unrelated to gastroesophageal reflux) who had at least moderate pain on ≥ 2 of the last 7 days were stratified by heartburn/regurgitation frequency (≤ 1 day/week (stratum 1) vs. ≥ 2 days/week (stratum 2)) and randomized to 4 weeks of double-blind treatment with twice-daily esomeprazole 40 mg or placebo. Chest pain relief during the last 7 days of treatment (≤ 1 day with minimal symptoms assessed daily using a 7-point scale) was analyzed by stratum in keeping with the predetermined analysis plan.

RESULTS:

Overall, 599 patients (esomeprazole: 297, placebo: 302) were randomized. In stratum 1, more esomeprazole than placebo recipients achieved chest pain relief (38.7% vs. 25.5%; P=0.018); no between-treatment difference was observed in stratum 2 (27.2% vs. 24.2%; P=0.54). However, esomeprazole was superior to placebo in a post-hoc analysis of the whole study population (combined strata; 33.1% vs. 24.9%; P=0.035).

CONCLUSIONS:

A 4-week course of high-dose esomeprazole provided statistically significant relief of unexplained chest pain in primary-care patients who experienced infrequent or no heartburn/regurgitation, but there was no such significant reduction in patients with more frequent reflux symptoms.

• Authors: Nigel W Flook, Paul Moayyedi, John Dent, Nicholas J Talley, Tore Persson, Björn W Karlson, Magnus Ruth
• Journal: The American journal of gastroenterology (Am J Gastroenterol) Vol. 108 Issue 1 Pg. 56-64 (Jan 2013) ISSN: 1572-0241 [Electronic] United States
• PMID: 23147520 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antacids
• Esomeprazole

Topics

• Administration, Oral
• Adolescent
• Adult
• Aged
• Antacids (therapeutic use)
• Chest Pain (drug therapy, etiology)
• Double-Blind Method
• Drug Administration Schedule
• Esomeprazole (therapeutic use)
• Female
• Gastroesophageal Reflux (complications)
• Heartburn (complications)
• Humans
• Intention to Treat Analysis
• Male
• Middle Aged
• Pain Measurement
• Primary Health Care
• Treatment Outcome
• Young Adult