September 10, 2024 | 2:57 PM
READING TIME: 3 minutes
Detailed results from the Phase III Finearts-Hf study demonstrate that, compared with placebo, finerenone showed a statistically significant improvement in cardiovascular outcomes in patients with heart failure (Hh) and a left ventricular ejection fraction (LVEF) greater than or equal to 40%. Finerenone – reports a note from Bayer – significantly reduced the risk of the primary composite endpoint of cardiovascular death and total heart failure events (primary and recurrent), defined as hospitalizations for heart failure or urgent heart failure visits, by 16% over a median duration of 32 months. Based on the results of Finearts-Hf – it is stated – finerenone is the first mineralocorticoid receptor antagonist to demonstrate decisive cardiovascular benefits in a Phase III study in patients with left ventricular heart failure. The results of the study were presented at the last Congress of the European Society of Cardiology Esc 2024 and simultaneously published in the ‘New England Journal of Medicine’.
“Treating patients with heart failure with LVEF ≥40% has been a significant challenge for many physicians and there is a high unmet clinical need as these patients are at substantial risk for serious cardiovascular events. Unlike heart failure with reduced ejection fraction, where many treatments are now available, we currently have limited treatment options with demonstrated efficacy for heart failure with LVEF ≥40%,” said Scott D. Solomon, MD, The Edward D. Frohlich Distinguished Chair, Professor of Medicine at Harvard Medical School, Director of Noninvasive Cardiology and Senior Physicians at Brigham and Women’s Hospital, and Chair of the Study Executive Committee. “With Finearts-HF being the first large-scale study of a selective nonsteroidal mineralocorticoid receptor antagonist in these still-at-risk heart failure patients, finerenone, once approved, could provide significant support to these vulnerable patients.”
The benefits shown in the primary endpoint – the note details – were consistent across all prespecified subgroups, regardless of background therapy, comorbidities, or hospitalization status, including those based on disease status (ejection fraction) or baseline use of SGLT2 inhibitors. Finerenone also significantly reduced the secondary endpoints of total heart failure events and improved patient-reported health status, as measured by change from baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) total symptom score.
Heart failure – the note continues – affects more than 60 million people worldwide; approximately half of these patients suffer from heart failure with a LVEF of ≥40% which is associated with multimorbidity, making the clinical condition complex to manage. More than half of these patients will die within 5 years.
“Bayer has a long history in cardiology and heart failure is one of our key areas of focus,” said Christian Rommel, Head of Research and Development, Bayer Pharmaceuticals Division. “These promising results confirm our continued commitment to patients with this debilitating condition. In the Finearts-Hf study, finerenone reduced cardiovascular outcomes in a complex patient population. This confirms the potential of the molecule, once approved, as a valid treatment option in heart failure with mildly reduced or preserved ejection fraction, regardless of background therapy and disease state. Finearts-Hf included a significant proportion of hospitalized or recently hospitalized patients, making the results particularly relevant for improving cardiovascular events in patients with limited treatment options.”
Approximately 6,000 patients were randomized at more than 630 hospitals in 37 countries worldwide to receive finerenone or a placebo once daily. In addition, patients in the study received their usual therapy to treat symptoms and comorbidities. Finerenone once daily significantly reduced the combined risk of cardiovascular death and total (primary and recurrent) heart failure events, defined as heart failure hospitalizations or urgent heart failure visits, by 16% over a median duration of 32 months.
