Heart Failure
Lauren Howell, PharmD
A NEJM study published in October 2024 found that finerenone may have a role in the treatment of patients with heart failure and mildly reduced or preserved ejection fraction. Patients treated with finerenone were found to have a significantly lower rate of a composite of total worsening heart failure events and death from cardiovascular causes than those treated with placebo.
Steroidal mineralocorticoid receptor antagonists (MRAs), such as finerenone, have already been established as capable of reducing mortality and morbidity in patients with heart failure and reduced ejection fraction. Until recently, data regarding their efficacy in patients with preserved or mildly reduced ejection fraction have not been widely available. In this international, multicenter, parallel-group, event-driven, double-blind, randomized trial, patients with heart failure and a left ventricular ejection fraction of 40% or greater were assigned in a 1:1 ratio, to receive finerenone or placebo, in addition to usual therapy. The maximum dose of finerenone was either 20 mg or 40 mg once daily, depending on baseline eGFR.
The primary outcome was a composite of total worsening heart failure events, defined as a first or recurrent unplanned hospitalization or urgent visit for heart failure and death from cardiovascular causes. The components of the primary outcome and safety were also assessed.
Study findings
Over the span of 32 months, the finerenone group had 1,083 primary outcome events in 624 of 3,003 patients, and the placebo group had 1,283 primary outcome events in 719 of 2,998 patients. The total number of worsening heart failure events was 842 among patients taking finerenone and 1,024 among patients in the placebo group. In the finerenone group, the percentage of patients who died from cardiovascular causes was 8.1%, compared to 8.7% in the placebo group.
A total of 20.4% of patients in the finerenone group and 20.6% in the placebo group discontinued therapy for reasons other than death. At the end of the 32-month period, 68.4% of patients in the finerenone group were taking the individualized target dose. Serious adverse events occurred in 38.7% of patients in the treatment group and 40.5% of patients in the placebo group. Increases in creatinine and potassium levels were more common with finerenone than placebo. Hypokalemia was less common with finerenone than with placebo. Mean systolic BP at 6 months was lower in the finerenone group.
Overall, in patients with heart failure and preserved or mildly reduced ejection fraction, finerenone resulted in a significantly lower rate of a composite of total worsening heart failure events and death from cardiovascular causes than placebo. The rate was also lower in the finerenone group for both total worsening heart failure events and death from cardiovascular causes individually. Finerenone was associated with a moderate benefit with respect to improvement in patient-reported health status but not in the NYHA functional class. The incidence of serious adverse events was similar between the two trial groups.
Application to pharmacy practice
There does seem to be a potential role for finerenone in the treatment of heart failure with mildly reduced or preserved ejection fraction. However, the study authors said that “we cannot determine on the basis of these data whether similar benefits would have been observed with other mineralocorticoid receptor antagonists.”
In an accompanying NEJM editorial, Theresa McDonagh, MD, said that “the trial results are likely to change the rather weak guideline recommendations for the use of MRAs in patients with chronic heart failure and an LVEF of 40% or greater.” She also said that “In the broader context of clinical trials of MRAs for chronic heart failure, the FINEARTS-HF trial helps to complete the picture. MRAs now have proven efficacy across the entire spectrum of chronic heart failure.” ■