FINEARTS-HF: Finerenone Could Find Role as Second Pillar in HFmrEF/HFpEF

Scott Solomon, MD
Credit: Brigham and Women's Hospital

Full results of the FINEARTS-HF trial signal the heart failure community, and potentially guidelines, could soon be anointing finerenone (Kerendia) as a second pillar for guideline-directed medical therapy in patients with heart failure and a left ventricular ejection fraction (LVEF) greater than 40%.

With the presentation of results at the European Society of Cardiology (ESC) Congress 2024 coming less than a month after the announcement of topline results in early August, the newest data released from the trial provides further insight into the role of the non-steroidal, selective mineralocorticoid receptor antagonist in treatment algorithms for heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF).

“The FINEARTS-HF trial provides the first definite evidence that an MRA is beneficial in HFmrEF/HFpEF,” explained principal investigator Scott Solomon, MD, senior physician and director of Noninvasive Cardiology, and Senior Physician at Brigham and Women’s Hospital. “We have 4 pillars of guideline-directed medical therapy in HFrEF but only SGLT2 inhibitors as a treatment option for HFmrEF/HFpEF. Given that finerenone was beneficial in patients already receiving an SGLT2 inhibitor, our findings point to finerenone as a new second pillar in HFmrEF/HFpEF.”

Approved in 2021 based on data from the FIDELIO-DKD and FIGARO-DKD trials, Bayer announced on August 05, 2024 the FINEARTS-HF trial had met its primary endpoint. FINEARTS-HF was a phase 3, international, multicenter, parallel-group, event-driven, double-blind, randomized trial and enrolled 6016 patients with a diagnosis of New York Heart Association class II-IV heart failure with an LVEF of 40% or greater, and receiving diuretic treatment for at least 30 days prior to randomization.

These patients were randomized in a 1:1 ratio to finerenone or placebo and subsequently followed for up to 42 months for a primary composite endpoint of cardiovascular death and total heart failure events, which investigators defined as hospitalizations for heart failure or urgent heart failure visits. Of note, 13 patients from a single site were excluded due to what investigators described as “serious violations of Good Clinical Practice guideline” and another patient was excluded because they underwent randomization twice. Ultimately, 2998 patients were randomized to placebo and 3003 were randomized to finerenone.

Investigators highlighted both the finerenone and placebo groups were similar in regard to baseline characteristics. Investigators pointed out the mean LVEF was 53% (SD, 8) and 69.1% met the criteria for NYHA functional class II heart failure. When examining baseline medication use, investigators found 84.9% were being treated with beta-blockers, 35.9% with ACE inhibitors, 35.0% with ARBs, 8.5% with ARNI, and 13.6% with SGLT2 inhibitors.

As Bayer previously highlighted in their topline data announcement, the FINEARTS trial met its primary endpoint, with use of finerenone associated with a statistically significant 16% relative reduction in rate of primary outcome events compared with placebo therapy (rate ratio [RR], 0.84; 95% confidence interval [CI], 0.74 to 0.95; P = 0.007). Specifically, 1083 primary outcome events occurred among 624 patients in the finerenone group and 1283 primary outcome events occurred among 719 patients in the placebo group.

Data from ESC Congress 2024 offered further insight into the trial, with analysis of individual components of the primary endpoint revealing use of finerenone was associated with an 18% relative reduction in incidence of heart failure hospitalization (RR, 0.82; 95% CI, 0.71 to 0.94; P = .006) and nonsignificant 7% relative risk reduction for death from cardiovascular causes (Hazard Ratio [HR], 0.93; 95% CI, 0.78 to 1.11). Additional data from ESC Congress 2024 demonstrated there was no differences between the finerenone and placebo groups for all-cause mortality (HR, 0.93; 95% CI, 0.83 to 1.06) or the composite kidney outcome (HR, 1.33; 95% CI, 0.94 to 1.89).

In their August release announcing topline results from the trial, Bayer disclosed plans to discuss the data and submission for regulatory approval with the FDA.

References:

1. SD Solomon, JJV McMurray, M Vaduganathan, et al. Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. Presented at: European Society of Cardiology Congress 2024. August 30 - September 2, 2024. London, UK.
2. Campbell P. Topline data prove Finerenone’s HFPEF benefit in Finearts-HF trial. HCP Live. August 5, 2024. Accessed September 1, 2024. https://www.hcplive.com/view/topline-data-prove-finerenone-s-hfpef-benefit-in-finerarts-hf-trial.