FINEARTS-HF Study Shows Finerenone Cuts CV death and Heart Failure Events in HFmrEF/HFpEF Patients
USA: Topline results from the FINEARTS-HF trial have revealed that finerenone (Kerendia), a nonsteroidal selective mineralocorticoid receptor antagonist (nsMRA), can lower the risk of cardiovascular (CV) death and total heart failure (HF) events in patients with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF).
Bayer announced that FINEARTS-HF met its primary endpoint, achieving a statistically significant reduction of the composite of CV death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits. The trial found no new safety concerns beyond those identified in previous studies with the drug.
Bayer will present the FINEARTS-HF data at the European Society of Cardiology (ESC) Congress 2024 in September and intends to discuss regulatory approval with the U.S. Food and Drug Administration (FDA) thereafter.
KERENDIA, a non-steroidal selective mineralocorticoid receptor antagonist (MRA), has already demonstrated cardiovascular benefits, including reductions in heart failure hospitalizations, cardiovascular death, and non-fatal myocardial infarction in adults with chronic kidney disease (CKD) and type 2 diabetes (T2D). The new topline data shows positive results for a broader patient population, including those with heart failure and a left ventricular ejection fraction (LVEF) greater than 40%, extending its potential benefits beyond CKD in T2D.
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