#104 Aldosterone antagonists in systolic heart failure – no longer an afterthought.

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- RALES:1 1,663 patients with Class III–IV heart failure on ACE inhibitors and diuretics. Given spironolactone or placebo. At 24 months:
- Statistically significant reduction in:
- Mortality: spironolactone 35%, placebo 46%, Number Needed to Treat (NNT) 10.
- Cardiovascular hospitalization: 32% vs. 40%, NNT 12.
- Adverse events:
- Gynecomastia/breast pain: spironolactone 10%, placebo 1%, Number Needed to Harm (NNH) 11.
- Serious hyperkalemia (potassium ≥6 mmol/L): not statistically different.
- Statistically significant reduction in:
- EMPHASIS-HF:2 2,737 patients with Class II heart failure with majority on ACE inhibitors, and β-blockers. Given eplerenone or placebo. At 21 months:
- Statistically significant reduction in:
- Mortality: eplerenone 13%, placebo 16%, NNT 34.
- Cardiovascular hospitalization: 22% vs. 29%, NNT 15.
- Adverse events:
- Hyperkalemia (>5.5 mmol/L) increased with eplerenone 12%, placebo 7%, NNH 22.
- No difference in gynecomastia or renal failure.
- Statistically significant reduction in:
- Aldosterone antagonists compare favourably to other agents used in congestive heart failure whose relative risk reductions for mortality are:
- Aldosterone antagonists1,2 ~25%.
- β-blockers5 ~29%.
- ACE inhibitors6,7 ~23%.
- Aldosterone antagonists are prescribed at less than half the rate of β-blockers and ACE inhibitors, and represent the greatest potential for increased systolic heart failure survival.8
- Titration to target doses of ACE inhibitors and β-blockers before adding aldosterone antagonists has been advocated,9 however the rates/doses of these medications were quite different in RALES and EMPHASIS-HF, yet they had similar outcomes.
- There is no head-to-head trial of spironolactone vs. eplerenone. Spironolactone ($12/month) could be used first and, if gynecomastia/breast pain develop, switch to eplereonone ($100/month).