Finerenone Significantly Reduces Cardiovascular Death, Heart Failure in the FINEARTS-HF Trial

Finerenone (Kerendia; Bayer), a non-steroidal mineralocorticoid receptor antagonist (MRA), achieved a statistically significant reduction of composite cardiovascular (CV) death and total, first, and recurrent, heart failure (HF) events in the phase 3 FINEARTS-HF trial (NCT04435626). The promising results are to be presented at the European Society of Cardiology Congress 2024 and plans to submit for regulatory approval with the FDA.¹

The observed success of finerenone may add additional therapeutic considerations for clinicians and patients balancing HF and the multiple associated comorbidities. Image Credit: © peopleimages.com - stock.adobe.com

Finerenone was first approved by the FDA in July 2021 to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, CV death, non-fatal myocardial infarction (MI), and hospitalization for HF in adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). It is an oral non-steroidal, selective MRA with a previously established CV benefit in adults with CKD and T2D that effectively reduced in hospitalization for HF, CV, and non-fatal MI. The newest topline data indicated finerenone demonstrated clinically meaningful results in patients diagnosed with HF.²

Use of steroidal MRAs has been limited due to safety concerns around risks of hyperkalaemia, gynecomastia, and kidney dysfunction; however, these may be mitigated by the non-steroidal MRAs. The randomized, double-blind, placebo-controlled, multicenter, event-driven phase 3 FINEARTS-HF trial is designed to evaluate the long-term efficacy and safety of finerenone among patients with diagnoses of symptomatic HF with reduced left ventricular ejection fraction (LVEF) (≥40%). The primary end point of the trial was the composite of CV death and total HF events, defined as hospitalizations for HF or urgent HF visits. The trial began on September 14, 2020.^2-4

About 6000 patients across 37 countries were randomized to receive either finerenone or placebo once daily for up to 42 months. At the end of the treatment period, researchers observed a statistically significant reduction in CV death and first or recurrent HF events. Additionally, no new safety concerns were identified.^2-4

“[We are] determined to drive research and innovations that have the potential to become treatment options for diseases with high unmet medical need, including for patients with mildly reduced or preserved ejection fraction,” said Christian Rommel PhD,, head of research and development at Bayer’s Pharmaceuticals Division, in a news release.²

Of the 6.7 million individuals in the US with HF, approximately 55% have an LVEF ≥ 40%. However, there are limited guidelines to direct treatment. The observed success of finerenone may add additional therapeutic considerations for clinicians and patients balancing HF and the multiple associated comorbidities, such as obesity, hypertension, and CKD.²

References

1. A study of eltrombopag in participants with severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection. ClinicalTrials.gov. NCT04435626. Updated August 2024. Accessed August 9, 2024. https://clinicaltrials.gov/ct2/show/NCT04435626

2. Bayer announces primary endpoint achieved in phase III finearts-hf cardiovascular outcomes study investigating kerendia® (finerenone) in patients with heart failure with mildly reduced or preserved ejection fraction. Business Wire. August 5, 2024. Accessed August 9, 2024. https://www.businesswire.com/news/home/20240804941740/en

3. Vaduganathan M, Claggett BL, Lam CSP, et al. Finerenone in patients with heart failure with mildly reduced or preserved ejection fraction: Rationale and design of the FINEARTS-HF trial. Eur J Heart Fail. May 14, 2024. doi:10.1002/ejhf.3253

4. Finearts - hf (finerenone in heart failure patients). National Research Authority. Accessed August 9, 2024. https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/finearts-hf-finerenone-in-heart-failure-patients/