From the Guidelines
Indication for Eplerenone
Eplerenone is indicated for patients with Heart Failure with Reduced Ejection Fraction (HFrEF) and NYHA class II to IV symptoms to reduce morbidity and mortality, as long as the eGFR is >30 mL/min/1.73 m2 and serum potassium is <5.0 mEq/L 1.
Key Considerations
- The starting dose of eplerenone is 25 mg orally daily, which can be increased to 50 mg daily orally after a month, with dose reduction by half for patients with eGFR 31 to 49 mL/min/1.73 m2 1.
- Regular monitoring of serum potassium levels and renal function is crucial, approximately 1 week, then 4 weeks, then every 6 months after initiating or intensifying eplerenone therapy 1.
- Eplerenone has been shown to provide high economic value in the treatment of HFrEF, with a cost per QALY of under $1000 1.
Clinical Evidence
The EPHESUS study demonstrated a 15% and 17% reduction in overall and cardiovascular mortality, respectively, with the addition of eplerenone to ACE inhibitors or ARBs and beta blockers in post-MI patients with HF 1. The RALES and EMPHASIS-HF studies also support the use of mineralocorticoid receptor antagonists, including eplerenone, in patients with HFrEF 1.
Important Warnings
- Eplerenone should be discontinued if serum potassium cannot be maintained at <5.5 mEq/L to avoid life-threatening hyperkalemia 1.
- Patients should be cautioned to avoid nonsteroidal anti-inflammatory agents and cyclo-oxygenase-2 inhibitors, which can lead to worsening renal function and hyperkalemia 1.
From the FDA Drug Label
Eplerenone tablets are an aldosterone antagonist indicated for: • Improving survival of stable patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction. • The treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
The indication for Eplerenone is:
- Improving survival of stable patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction
- The treatment of hypertension, to lower blood pressure 2 2
From the Research
Indications for Eplerenone
- Eplerenone is indicated for the treatment of hypertension and heart failure, specifically for patients with left-ventricular systolic dysfunction (ejection fraction <40%) and clinical evidence of heart failure following acute myocardial infarction 3, 4, 5.
- It is also used to reduce the risk of cardiovascular mortality and morbidity in adult patients with chronic systolic heart failure and mild symptoms 6.
- Eplerenone has been shown to be beneficial in reducing mortality and cardiovascular morbidity in post-myocardial infarction patients with systolic heart failure currently taking standard heart failure medications 3, 7.
Patient Population
- Patients with hypertension, including those with diabetes and renal impairment 3, 7.
- Patients with heart failure, including those with left-ventricular systolic dysfunction and clinical evidence of heart failure following acute myocardial infarction 4, 5, 6.
- Patients with chronic systolic heart failure and mild symptoms, in addition to standard optimal therapy 6.
Benefits and Risks
- Eplerenone has been shown to reduce blood pressure, improve survival, and reduce cardiovascular morbidity in patients with hypertension and heart failure 3, 4, 7.
- The most severe side effect of eplerenone is hyperkalemia, which can be life-threatening in some cases 3, 5, 6.
- Eplerenone has a lower risk of sex hormone-related adverse effects, such as gynecomastia and vaginal bleeding, compared to spironolactone 4, 5, 6.