Kerendia Reduces Cardiovascular Deaths in Patients with Cardio-Kidney-Metabolic Conditions

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New data from the FINE-HEART trial found that Bayer’s Kerendia (finerenone) demonstrated a numerical reduction in cardiovascular (CV) deaths but narrowly missed statistical significance with an 11% relative risk reduction in high-risk patient populations. Despite missing statistical significance, the effects of Kerendia on CV death were generally consistent across the 16 subgroups examined in FINE-HEART, with results suggesting that the treatment offers benefits across a broad range of high-risk patient populations, which encompassed cardiovascular, kidney, and metabolic conditions.¹

“Given the strong epidemiological overlap and shared mechanistic pathways of cardio-kidney-metabolic conditions, these data are welcome news for clinicians. It is great to see that finerenone addresses fundamental drivers of heart and kidney pathophysiology,” said Muthiah Vaduganathan, MD, MPHD, cardiologist, co-director, Center for Cardiometabolic Implementation Science at Brigham and Women’s Hospital and faculty, Harvard Medical School, in a press release. “While the individual Phase III studies with finerenone were not powered to evaluate CV mortality or efficacy in key subgroups, the high number of patients in FINE-HEART allowed us to explore these outcomes, and provided important, encouraging insights for clinicians for the treatment of these multimorbid patients, confirming efficacy is consistent across key subgroups.”

FINE-HEART is a protocol prespecified, participant-level pooled analysis that consisted of an estimated 19,000 patients with heart failure (HF) and/or chronic kidney disease (CKD) and type 2 diabetes (T2D) from prior Phase III studies. The randomized FIDELIO-DKD and FIGARO-DKD trials included around 13,000 patients with CKD and T2D with albuminuria (UACR≥30mg/g) across 48 countries. Additionally, FINEARTS-HF included around 6,000 patients with symptomatic HF and a left ventricular ejection fraction (LVEF) of ≥40%, elevated natriuretic peptides, and evidence of structural heart disease across 37 countries. The primary endpoint was the reduction of CV deaths overall. Secondary endpoints included a kidney composite endpoint with a ≥50% sustained decline in eGFR, HF hospitalization, the composite of CV death or HF hospitalization, new-onset atrial fibrillation, major adverse CV events, all-cause death, all-cause hospitalization, and the composite of all-cause death or all-cause hospitalization.

Results found that in a prespecified sensitivity analysis including CV and undetermined deaths, finerenone achieved a significant 12% reduction. Further, the treatment also lowered all-cause mortality by 9%, reduced the risk of kidney failure by 20%, and decreased heart failure hospitalizations by 17%.

The safety profile of Kerendia was found to be consistent with results from previous studies. Bayer stated that Kerendia is a non-steroidal, selective mineralocorticoid receptor that works to target MR/renin-angiotensin-aldosterone system overreaction, addressing chronic and progressive inflammatory and fibrotic drivers, known to be strongly associated with HF and CKD.¹

According to the Centers for Disease Control and Prevention (CDC), heart disease is the leading cause of death for people of most racial and ethnic groups in the United States. From 2019 to 2020, heart disease cost about $252.2 billion in health care services, medicines, and lost productivity due to death.²

“Heart failure, chronic kidney disease, and type 2 diabetes have shared disease drivers, and FINE-HEART, including around 19,000 patients from three Phase studies, complements and confirms the positive results seen so far with finerenone,” said Christian Rommel, PhD, head, research and development, pharmaceuticals division, Bayer, in the press release. “These findings are highly relevant for clinicians as they demonstrate that finerenone can improve outcomes in these patients with a high unmet medical need."

References

1. Late-Breaking data from finerenone pooled analysis on cardiovascular and kidney outcomes and mortality in high-risk patient populations presented at ESC Congress 2024. Bayer. September 1, 2024. Accessed September 4, 2024. https://www.bayer.com/media/en-us/late-breaking-data-from-finerenone-pooled-analysis-on-cardiovascular-and-kidney-outcomes-and-mortality-in-high-risk-patient-populations-presented-at-esc-congress-2024/

2. Heart Disease Facts. CDC. Accessed September 4, 2024. https://www.cdc.gov/heart-disease/data-research/facts-stats/index.html#:~:text=Heart%20disease%20in%20the%20United%20States&text=One%20person%20dies%20every%2033,1%20in%20every%205%20deaths.