The efficacy and safety of spironolactone in the treatment of chronic heart failure after acute myocardial infarction

Objective: To evaluate the efficacy and safety of spironolactone among patients with acute myocardial infarction complicated with heart failure. Method: All patients with symptomatic left ventricular dysfunction were routinely managed with a combination of 4 types of drugs: a diuretic, an ACE inhibitor, beta-blocker and (usually) digitalis. 85 patients were randomly assigned to two groups: 43 patients in spironolactone group and 42 patients as control. Spironolactone was orally given 20mg once daily. The primary end points were death from any cause and death from cardiovascular causes or hospitalization for worsening heart failure. Result: During a mean follow-up of 12 months, there were 1 death in the spironolactone group and 7 deaths in the placebo group (2.3% vs 16.7%, p0.05). Of these deaths, 1 in the spironolactone group and 6 in the placebo group were attributed to cardiovascular causes (2.3% vs 14.3%, p0.05). The frequency of hospitalization for worsening heart failure was significantly lower in the spironolactone group than in the placebo group(9.3% vs 26.2%, p0.05). Gynecomastia was reported in 1 patient who was treated with spironolactone. No hyperkalemia occurred in both groups of patients. Conclusion: The addition of spironolactone to optimal medical therapy is effective and safe among patients with acute myocardial infarction complicated with heart failure.