Routine Spironolactone in Acute Myocardial Infarction
Abstract
Spironolactone, a mineralocorticoid receptor antagonist, is established in the treatment of heart failure following myocardial infarction (MI). However, its routine use post-MI remains uncertain.
This multicenter trial (CLEAR) randomized 7062 patients with MI 3537 receiving spironolactone (25 mg daily) and 3525 receiving placebo—evaluating two primary outcomes over a median follow-up of three years:
- Death from cardiovascular causes or new/worsening heart failure
- First occurrence of MI, stroke, new/worsening heart failure, or cardiovascular death
Results showed no significant reduction in either primary outcome:
- 183 events (1.7 per 100 patient-years) in spironolactone vs. 220 events (2.1 per 100 patient-years) in placebo (hazard ratio, 0.91; 95% CI, 0.69–1.21; P=0.51).
- 280 patients (7.9%) in spironolactone vs. 294 patients (8.3%) in placebo experienced secondary outcome events (hazard ratio, 0.96; 95% CI, 0.81–1.13; P=0.60).
While spironolactone lowered blood pressure slightly, it did not improve survival or reduce heart failure risk. Hyperkalemia (potassium >5.5 mmol/L) leading to discontinuation occurred more frequently with spironolactone (1.1% vs. 0.6%). Gynecomastia was also more common (2.3% vs. 0.5%).
Keywords:
myocardial infarction
spironolactone
mineralocorticoid receptor antagonist
heart failure
CLEAR trial
cardiovascular mortality
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