Eplerenone in Patients With Systolic Heart Failure and Mild Symptoms: Analysis of Repeat Hospitalizations

Study Questions:

How does eplerenone impact readmission rates for patients with mild heart failure (HF)?

Methods:

This was a secondary analysis of the EMPHASIS-HF (Eplerenone in Mild Patients Hospitalizations and Survival Study in Heart Failure) trial, which compared eplerenone 50 mg daily versus placebo in patients with an ejection fraction ≤35% and New York Heart Association (NYHA) class II symptoms. The primary outcome of interest was the cumulative incidence of HF hospitalizations and the rate of HF hospitalizations using mortality as a competing risk.

Results:

Over a median 25 months of follow-up, death occurred in 17% (n = 458) of patients (n = 2,737 randomized), and 37% (n = 1,013) had at least one hospitalization. In total, there were 1,985 hospital admissions, and 40% (n = 793) of these were due to HF. Patients taking eplerenone had a 32% (95% confidence interval [CI], 20-43%) relative risk reduction in initial HF admission. By 1 year, the cumulative number of HF hospitalizations was 20.3 per 100 patients on placebo versus 9.20 on eplerenone (treatment difference, 11.6 hospitalizations per 100 patients). The impact on hospitalization rate was greatest in the first year then attenuated. Eplerenone therapy reduced the rate of HF hospitalizations significantly compared to placebo (rate ratio, 0.53; 95% CI, 0.42-0.66; p < 0.001).

Conclusions:

Patients with mild HF treated with eplerenone had significantly fewer HF hospitalizations.

Perspective:

This analysis of the EMPHASIS-HF trial demonstrated that patients with ‘mild’ HF still have high admission frequencies for HF. Further, it demonstrated benefit with eplerenone therapy in reducing the total number of hospital readmissions, especially within the first year. There are several statistical obstacles the authors acknowledge in repeated measure analyses such as that by Rogers et al., where repeat observations on patients are not independent data points. However, the authors do raise an important question (in this era of accountable care) of ‘what is the best outcome measure for HF patients?’ besides mortality. Preventing one admission is good, but preventing multiple readmissions seems even more important.

Clinical Topics: Dyslipidemia, Heart Failure and Cardiomyopathies, Lipid Metabolism, Acute Heart Failure

Keywords: Follow-Up Studies, Patient Readmission, Risk Reduction Behavior, Mineralocorticoid Receptor Antagonists, Heart Failure, Apolipoprotein A-I, Confidence Intervals, Spironolactone, New York


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