Document Detail


Acid-suppressive therapy with esomeprazole for relief of unexplained chest pain in primary care: a randomized, double-blind, placebo-controlled trial.
MedLine Citation:
PMID:  23147520     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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
Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-11-13
Journal Detail:
Title:  The American journal of gastroenterology     Volume:  108     ISSN:  1572-0241     ISO Abbreviation:  Am. J. Gastroenterol.     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-01-04     Completed Date:  2013-02-27     Revised Date:  2013-04-19    
Medline Journal Info:
Nlm Unique ID:  0421030     Medline TA:  Am J Gastroenterol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  56-64     Citation Subset:  IM    
Affiliation:
University of Alberta, Edmonton, Alberta, Canada. nflook@shaw.ca
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00251901
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adolescent
Adult
Aged
Antacids / therapeutic use*
Chest Pain / drug therapy*,  etiology
Double-Blind Method
Drug Administration Schedule
Esomeprazole Sodium / 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
Chemical
Reg. No./Substance:
0/Antacids; L2C9GWQ43H/Esomeprazole Sodium
Comments/Corrections
Comment In:
Praxis (Bern 1994). 2013 Mar 27;102(7):423-4   [PMID:  23531912 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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