Acid-Suppressive Therapy With Esomeprazole for Relief of Unexplained Chest Pain in Primary Care: A Randomized, Double-Blind, Placebo-Controlled Trial


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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 apost-hocanalysis 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.

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