FINEARTS-HF Data Examine Finerenone Across Bilirubin Levels: Jawad Haider Butt, MD, PhD

New FINEARTS-HF (NCT04435626) data presented by Jawad Haider Butt, MD, PhD, of Glasgow Cardiovascular Research Center, University of Glasgow, at the American College of Cardiology Annual Scientific Session (ACC.25) explored the effects of finerenone (Kerendia; Bayer HealthCare) on clinical outcomes and bilirubin levels in patients with heart failure with preserved ejection fraction. Although recent findings have established the efficacy of the new mineralocorticoid receptor antagonists (MRAs) in reducing the risk of heart failure worsening and hospitalizations in patients with heart failure with mildly reduced and preserved ejection fraction, this analysis provides new insights into finerenone’s potential benefits across different bilirubin levels.

Key findings indicate that finerenone's efficacy in reducing cardiovascular death and worsening heart failure events did not significantly differ across baseline bilirubin tertiles. However, investigators identified a trend suggesting more pronounced benefit with higher baseline bilirubin levels when bilirubin was considered as a continuous variable. Finerenone treatment also consistently reduced bilirubin levels early after initiation, pointing to a potential mechanism of action beyond its primary cardiovascular benefits.

This transcript has been lightly edited; captions were auto-generated.

Transcript

How do these findings build on previous data yielded from the FINEARTS-HF research?

These data are unique in that sense that we have not looked at the liver biomarkers in FINEARTS before; they do build upon other data. We have done other analyses in patients with heart failure with reduced ejection fraction, and we have shown that liver biomarkers are associated with worse outcomes. Now, we have confirmed that in patients with another heart failure phenotype, that is, those with a mild or preserved ejection fraction. In addition, we have established—which is quite unique—that finerenone is effective regardless of liver biomarker concentrations at baseline.

Given the potential benefits of finerenone, what challenges exist in ensuring equitable access to this therapy, particularly for patients with advanced heart failure or socioeconomic barriers to care?

That is a very interesting and very important question, because we do already have MRAs on the market. We have the steroidal MRAs, both spironolactone and eplerenone, and they are much cheaper than finerenone. Currently, finerenone is not approved for treating patients with heart failure, so whenever it gets approved, then we have the question about who will cover the cost because at the moment, finerenone is quite expensive. On the other hand, spironolactone and eplerenone are quite cheap because they have been on the market for many, many years. But then, we have never had a positive trial with the steroidal MRAs in patients with heart failure with a mildly reduced or preserved ejection fraction.

Reference

Haider Butt J, Henderson A, Claggett B, et al. Finerenone, bilirubin, and heart failure with mildly reduced or preserved ejection fraction: an analysis from FINEARTS-HF. Presented at: ACC.25; March 29-31, 2025; Chicago, Illinois. Session 904.