Q&A

Selective aldosterone blockade reduces mortality after MI

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  • BACKGROUND: Family physicians commonly manage patients with congestive heart failure following acute MI. This trial examined the effects of selective aldosterone blockade on morbidity and mortality in patients who suffered an acute MI complicated by left ventricular dysfunction and clinical signs of congestive heart failure.
  • POPULATION STUDIED: This industry-sponsored study enrolled 6642 patients at medical centers in 37 different countries. Inclusion criteria included acute MI (diagnosed according to “standard criteria”) within the previous 2 weeks; left ventricular dysfunction (ejection fraction <40%), and heart failure as documented by clinical findings of pulmonary rales, radiographic changes, or a third heart sound.
  • STUDY DESIGN AND VALIDITY: Subjects were randomized to receive either eplerenone 25 mg/d titrated to a maximum of 50 mg/d (n=3391), or placebo (n=3313). All patients concurrently received 1; to“optimal medical management1; that included ACE inhibitors, beta-blockers, diuretics, aspirin, statins, and coronary reperfusion therapy. Endpoints were analyzed using the Cox proportional-hazards regression and the time to event was summarized using standard Kaplan-Meier curves. All final data analysis was performed by the study sponsor.
  • OUTCOMES MEASURED: Primary endpoints were time to death from any cause and time to death or hospitalization for cardiovascular events (stroke, MI, heart failure, or arrhythmia). Secondary endpoints were the absolute presence of death or hospitalization. Endpoints were adjudicated by blinded assessors.
  • RESULTS: Groups were similar at baseline. Patients were followed every 3 months for an average of 16 months. Mortality from all causes was lower in the eplerenone group (14.4% vs 16.7%; P<.01; number needed to treat [NNT]=44). Cardiovascular death and hospitalization were also reduced in the eplerenone group (26.7% vs 30%; P<.01; NNT=33).


 

PRACTICE RECOMMENDATIONS

Eplerenone, a selective mineralocorticoid receptor antagonist currently approved by the Food and Drug Administration for treatment of hypertension, reduces mortality following myocardial infarction (MI) in patients with left ventricular dysfunction and clinical signs of congestive heart failure. Previous research by the same group established that spironolactone does the same at lower cost than eplenerone.1

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