FINEARTS-HF: Topline Results Support Role for Finerenone in Mildly Reduced or Preserved EF

Finerenone (Kerendia), a nonsteroidal, selective mineralocorticoid receptor antagonist (nsMRA) can reduce the composite of cardiovascular death and total heart failure events in patients with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF), according to topline results from FINEARTS-HF.

The randomized trial is the first to show a CV benefit for an nsMRA in this patient population, Bayer AG announced today.

Findings from the phase III trial bolster the CV benefits that have already been shown with the drug in patients with chronic kidney disease (CKD) associated with type 2 diabetes. Back in 2021, the US Food and Drug Administration approved finerenone for reducing the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, CV death, nonfatal MI, and HF hospitalization in that population. Previously, both FIGARO-DKD and FIDELIO-DKD had demonstrated the CV benefits of finerenone in patients with diabetes across a broad spectrum of kidney disease and formed the basis for its approval. 

In announcing the FINEARTS-HF results, a Bayer press release noted that guideline-directed medical treatment options for HF patients with LVEF ≥ 40% are limited, constituting a “high unmet medical need.” While many patients with HFmrEF/HFpEF have CKD and other comorbidities, the FINEARTS-HF trial was not limited to CKD in diabetes.

The multinational trial enrolled approximately 6,000 patients (mean age 72 years; 46% women), including a high-risk population enrolled during or shortly after a HF hospitalization. All were age 40 or older with NYHA class II-IV symptoms, LVEF ≥ 40%, evidence of structural heart disease, and diuretic use for at least the previous 30 days. Patients were randomized to finerenone titrated to a maximum of 40 mg once daily or matching placebo.

In the press release, Bayer said full data from FINEARTS-HF will be presented at the upcoming European Society of Cardiology Congress 2024, which begins later this month. They also note that they plan to discuss submission for regulatory approval for this additional indication.