Finerenone reduces CV death or total HF events in patients with HFmrEF or HFpEF

This summary is based on the presentation of Scott Solomon, MD (Boston, MA, US) at the ESC Congress 2024 –Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction: FINEARTS-HF

Introduction and methods

Currently, the only class I indicated therapy for patient with heart failure with mildly reduced or preserved ejection fraction (LVEF≥ 40%) is SGLT2 inhibitors. Steroidal MRAs have shown to reduce morbidity and mortality in patients with HFrEF, but data for patients with HFpEF are not definitive. In the TOPCAT trial, no significant benefit with spironolactone was demonstrated, but post-hoc analyses suggest potential benefit in some patients.

Finerenone is a non-steroidal MRA with distinct physiochemical properties compared with steroidal MRAs. In patients with diabetes and CKD, treatment with finerenone reduces kidney and CV outcomes.

FINEARTS-HF was a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of finerenone compared with placebo in patients with heart failure with mildly reduced or preserved ejection fraction (LVEF≥40%). 6001 Patients with symptomatic HF (NYHA class II-V) with elevated natriuretic peptide levels and structural heart disease were randomized in 1:1 ratio to finerenone 10, 20 or 20, 40 mg dosing (based on eGFR) or matching placebo. Median follow-up was 32 months.

The primary endpoint was a composite of CV death or total HF events (hospitalizations/urgent visits).

Main results

• The primary endpoint of CV events or total HF events was reduced in the finerenone group compared with the placebo group (14.3/100 pt-yrs vs. 17.6 pt-yrs, RR 0.84; 95%CI: 0.74-0.95, P=0.007).
• The secondary endpoint of total HF events was also reduced in the finerenone group compared with the placebo group (RR 0.82, 95%CI: 0.70-0.94, P=0.006).
• There was no difference in CV death and all-cause death between the 2 groups.
• The change in KCCQ-TSS in the finerenone group was +8 and in the placebo group +6.4, resulting in a significant between-arm difference of +1.6 (0.8-2.3, P<0.001).
• There was consistency across all pre-specified subgroups, including based on LVEF and in patients who were taking SGLT2 inhibitors at baseline.
• With regard to safety, hyperkalemia and hypotension occurred more often, and hypokalemia was less common in patients receiving finerenone.

Conclusion

Among patients with heart failure with mildly reduced or preserved ejection fraction, use of finerenone reduced the risk of the composite endpoint of CV death or total heart failure events compared with placebo. Moreover, compared with placebo, use of finerenone resulted in reduced total heart failure events and improved overall health status (measured by KCCQ-TS). Solomon ended by stating that “these data support the use of finerenone in patients with heart failure with mildly reduced or preserved ejection fraction, and offer a new option for treating patients with this disease.”

- Our reporting is based on the information provided at the ESC Congress 2024 -

The findings of this study were simultaneously published in N Engl J Med.