During the 2024 European Society of Cardiology (ESC) Congress, Bayer will unveil late-breaking results from the Phase III FINEARTS-HF trial evaluating finereneone’s efficacy in patients with HF and left ventricular ejection fraction (LVEF) of 40% or higher.

Finerenone, marketed as KERENDIA®, is currently approved for reducing cardiovascular risks in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

FINEARTS-HF Trial: Key Findings

The FINEARTS-HF trial assessed the efficacy and safety of finereneone in reducing cardiovascular and HF events in patients with symptomatic HF and LVEF of 40% or higher. The trial enrolled approximately 6,000 patients randomly assigned to finereneone or placebo for up to 42 months.

Earlier this month, Bayer announced that the trial met its primary endpoint, demonstrating a statistically significant reduction in the composite of cardiovascular death and total HF events (hospitalizations or urgent HF visits).

FINE-HEART Study: Integrated Analysis

The FINE-HEART study pooled data from three Phase III trials (FINEARTS-HF, FIDELIO-DKD, and FIGARO-DKD) to explore finereneone’s effects on cardio-kidney outcomes in patients with HF with LVEF of 40% or higher and/or CKD and T2D.

KERENDIA® in HF Patients

The positive results from the FINEARTS-HF trial indicate that finereneone may benefit a broader patient population, including those with HF and LVEF of 40% or higher, regardless of CKD/T2D status.

Additional Information

Bayer will also present data from the OCEANIC-AF trial investigating asundexian, an investigational anticoagulant, in patients with atrial fibrillation. No health authority has yet approved Asundexian.

For more information on KERENDIA®, consult the full Prescribing Information.

Source link: http://www.businesswire.com/news/home/20240829465836/en/ESC-Congress-2024-Bayer-to-Present-Phase-III-KERENDIA%C2%AE-finerenone-Data

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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.