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134 ESOMEPRAZOLE FOR TREATMENT OF UNEXPLAINED CHEST PAIN IN PRIMARY CARE: A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER STUDY N Flook1, BW Karlson2, M Ruth2 AIMS: To compare esomeprazole with placebo for relief of unexplained chest pain.
1University of Alberta, Edmonton, Alberta; 2AstraZeneca R&D, Mölndal, Sweden
METHODS: Primary care patients with =>2 weeks of chest pain or discomfort (moderate severity on =>2 of the last 7 d) of unexplained cause were included. Patients with identifiable non-cardiac causes of chest pain (e.g. musculoskeletal disorders, gastroesophageal reflux disease) were excluded, as were patients with known cardiac disorders, abnormal ECG, troponin or exercise test results at baseline. Patients were randomized to esomeprazole 40 mg twice daily or placebo for 4 weeks, and stratified according to frequency of heartburn or acid regurgitation as follows: <2 d/week (stratum 1); or =>2 d/week (stratum 2). The primary variable was relief of chest pain or discomfort (measured on a 7-grade Likert scale), analyzed by stratum. Relief was defined as <=1 d with minimal symptoms during the last 7 d of treatment.
RESULTS: The intention-to-treat population comprised 599 patients (316 men, mean age 46.9 y [18-76 y]). In total, 297 patients received esomeprazole and 302 received placebo. Esomeprazole was significantly more effective than placebo for the relief of chest pain in stratum 1 (38.7% vs 25.5%, P = .018). However, the difference was not statistically significant in stratum 2 (27.2% vs 24.2%). Esomeprazole was significantly more effective than placebo when the two strata were combined in a post-hoc analysis (33.1% vs 29.4%; P = .035). Esomeprazole was generally well tolerated. There were no deaths in the study. One patient (placebo group) experienced a nonfatal myocardial infarction during the study. Discontinuations due to adverse events were similar between the esomeprazole and placebo groups (3.3% and 2.9%, respectively).
CONCLUSIONS: Esomeprazole is more effective than placebo for relief of unexplained chest pain in primary care patients. This treatment regimen is generally well tolerated when patients with identifiable non-cardiac causes of chest pain or known cardiac disorders, abnormal ECG, troponin or exercise test results have been excluded.
Supported by AstraZeneca. NF has received research support from AstraZeneca. Other authors are employees of AstraZeneca