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

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.
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.
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).
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.
AuthorsNigel W Flook, Paul Moayyedi, John Dent, Nicholas J Talley, Tore Persson, Björn W Karlson, Magnus Ruth
JournalThe American journal of gastroenterology (Am J Gastroenterol) Vol. 108 Issue 1 Pg. 56-64 (Jan 2013) ISSN: 1572-0241 [Electronic] United States
PMID23147520 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Antacids
  • Esomeprazole
  • 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

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