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QUESTION: In patients with acute myocardial infarction (MI) complicated by left ventricular dysfunction and congestive heart failure (CHF), does adjunctive treatment with eplerenone reduce morbidity and mortality more than placebo?
Design
Randomised {allocation concealed*}†, blinded (clinicians, patients, outcome assessors, {data collectors, data analysts, and manuscript writers}†),* placebo controlled trial with mean 16 months of follow up (Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study [EPHESUS]).
Setting
674 centres in 37 countries.
Patients
6642 patients (mean age 64 y, 71% men) with acute MI, left ventricular dysfunction (ejection fraction ≤40%), and HF (confirmed by the presence of pulmonary rales, pulmonary venous congestion on chest radiography, or a third heart sound). Exclusion criteria included potassium sparing diuretics, serum creatinine ≥220 μmol/l, and serum potassium >5.0 mmol/l before randomisation. 6632 patients (99.8%) were included in the …
Footnotes
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Source of funding: Pharmacia.
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For correspondence: Dr B Pitt, University of Michigan, Ann Arbor, MI, USA. bpitt{at}umich.edu
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Abstract and commentary also appear in ACP Journal Club.
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↵† Information provided by author.