Finerenone May Be Added as Standard Care for Patients with Heart Failure and Mildly Reduced or Preserved Ejection Fraction

The non-steroidal mineralocorticoid receptor antagonist (MRA) finerenone was shown in 2 trials (FIDELIO-DKD and FIAGARO-DKD) to significantly decrease cardiovascular (CV) events and slow progression of kidney function in patients with type 2 diabetes and chronic kidney diseases (CKD). The only medications recommended as first line therapy for patients with heart failure and mildly reduced ejection fraction and preserved ejection fraction (HFmrEF/HFpEF) are the sodium-glucose co-transporters type 2 inhibitors (SGLT-2i). Recently, finerenone was evaluated in patients with HFmr/HFpEF in a trial called the FINEARTS-HF. The latter was a randomized, double-blind, placebo-controlled international trial with the primary composite outcome consisting of first and recurrent (i.e. total) worsening heart failure (HF) events and death from CV causes. Patients included were 40 years or older with left ventricular ejection fraction (LVEF) ≥40%, New York Heart Association (NYHA) functional status, mostly II and III, elevated natriuretic peptides, and evidence of structural heart disease. After a median follow-up of 32 months, 14.9 and 17.7 primary outcome events per 100 patient-year occurred in the finerenone and placebo group, respectively, rate ratio (RR) 0.84 (95% CI, 0.74 to 0.95; P 0.007). The significant reduction in the primary outcome was mainly driven by the reduction in total worsening HF events (RR 0.82; 95% CI 0.71 to 0.94), whereas reduction in CV death did not reach statistical significance RR 0.93 (95% CI, 0.78 to 1.11). Results of secondary outcomes of the FINEART-HF trial showed a trend towards reduction in all-cause death [hazard ratio (HR) 0.93, 95% CI, 0.83 to 1.06)] and worsening of kidney composite outcome HR 1.33 (95% CI, 0.94 to 1.89). There was no heterogeneity in results in different patient subgroups classified by diabetes status, baseline EF, and use of sodium-glucose co-transporters type 2 inhibitors (SGLT-2is). The most common adverse effects of finerenone were hyperkalemia (serum potassium > 5.5 mmol/L) occurring in 14.3% and 6.9% of patients in the finerenone and placebo, groups, respectively. In summary, finerenone is a useful agent for treatment of HFmr/HFpEF that can be added to SGLT2i. Its main limitations are hyperkalemia and possibly worsening kidney function in patients with (HFmr/HFpEF). Long-term studies are required to evaluate the safety of finerenone in patients with (HFmr/HFpEF).