Spironolactone saves lives in heart failure

Date: July 21, 1999
Time: 9:00 am

The aldosterone antagonist spironolactone cuts the risk of death and the rate of hospitalization by one-third in patients with severe heart failure, according to a large international study. The multicentre study was stopped earlier than planned and its results have been released on the Internet before print publication in the New England Journal of Medicine.

The Randomized Aldactone Evaluation Study was conducted in 15 countries on 5 continents, enrolling 1663 patients in 195 centres. Patients had a ventricular ejection fraction of 35% or less and were receiving standard therapy for heart failure -- an angiotensin-converting-enzyme (ACE) inhibitor, a loop diuretic and, in some cases, digoxin. Spironolactone or placebo were added to the regimen on a randomized basis. After follow-up of an average of 2 years, the mortality rate was 35% in the spironolactone group and 46% in the placebo group. Spironolactone treatment also lowered the rate of hospitalization and resulted in significant improvement in the symptoms of heart failure. The main side effects are gynecomastia and breast pain, which affected 10% of men taking the drug.

Spironolactone reduces levels of aldosterone, a steroid produced at up to 20 times the normal levels in patients with heart failure. Aldosterone contributes to the sodium retention and edema that characterize the condition. According to an accompanying editorial, "the importance of aldosterone in congestive heart failure has been overlooked in recent years" because ACE inhibitors were thought to eliminate aldosterone production. However, it now appears that ACE inhibitors suppress aldosterone only briefly.

Based on these results, the authors and editorialist recommend adding spironolactone to standard therapy for patients with severe heart failure. -- C.J. Brown

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