Dr Chris Kramer on the Clinical Importance of Finerenone for Patients With Heart Failure

Christopher Kramer, MD, vice president of the American College of Cardiology (ACC), has been involved in multiple studies aimed at improving treatment strategies for difficult-to-treat patients with mildly reduced or preserved ejection fraction. In this interview, Kramer discusses the latest findings from the finerenone clinical trials presented at the 2024 European Society of Cardiology Congress, focusing on the results of the FINEARTS study, a pivotal investigation into the effectiveness of finerenone—a mineralocorticoid receptor antagonist—in managing heart failure with ejection fractions greater than 40%. He provides an in-depth overview of the study’s outcomes, its implications for clinical practice, and what it means for the future of heart failure treatment.

This transcript has been lightly edited for clarity.

Transcript

Can you share an overview of the latest data on finerenone in heart failure presented in the FINEARTS session?

So, FINEARTS was a study of the drug finerenone, which is a mineralocorticoid receptor blocker in heart failure with mildly reduced or preserved ejection fraction—patients with ejection fraction more than 40%. This has been a difficult-to-treat population. Patients with heart failure with reduced ejection fraction have multiple drug options; in fact, there are 4 classes of drugs that are proven beneficial in that population. Patients with either mildly reduced or preserved ejection fraction have very limited proven options. Most recently, SGLT2 [sodium-glucose cotransporter 2] inhibitors have been shown to be beneficial.

There has been one prior large study of mineralocorticoid receptor blockers, the TOPCAT study, which was of spironolactone. It didn't reach its primary end point. It was problematic in that half the patients enrolled in that study were enrolled in parts of the world that it wasn't clear they actually had heart failure. And so there has been controversy around this study. So there needed to be another study of this class of agents in heart failure preserved ejection fraction. This is that study. So, that's by way of background.

Finerenone is a is a drug that's in that class, and these patients were randomized to placebo, one of 2 doses of finerenone. And the bottom line is that finerenone therapy was associated with a reduced combined end point of heart failure exacerbation and cardiovascular death. All of the differences were in heart failure worsening. There was no difference between groups in cardiovascular deaths in terms of the absolute numbers, but all of the difference was in heart failure exacerbation, heart failure hospitalizations, and those were highly statistically significantly different. And then when you combine the end point, they were highly different. There was also improvement in the KCCQ [Kansas City Cardiomyopathy Questionnaire] score, which was a measure of how patients feel and the amount of activities they can do in terms of daily life; so that improved in the treatment group, where it was much more so than in the placebo group.

There were a couple of areas where there weren't differences. There were no differences in the NYHA [New York Heart Association] class, which is a broad way of understanding how short of breath patients feel, but it's a qualitative measure, and there was no difference there. There were also no differences in terms of safety outcomes. The drug was associated with some increase in hyperkalemia, a known side effect of the drug, but none of those episodes were life-threatening. There were no deaths from hyperkalemia. There were a small number of hospitalizations. It actually reduced the number of hypokalemic episodes because the mechanism of the drug is, in part, to raise potassium. Blood pressure was a little bit lower in the treated group, as one would expect as a blood pressure–lowering drug, and maybe some of the benefits are from that.

But the bottom line is, it's really the second class of agents now that have been shown to be beneficial in heart failure with preserved ejection fraction. So now you have SGLT2 inhibitors, and now a second class, mineralocorticoid receptor antagonists, now proven to have benefit in terms of reducing heart failure hospitalizations. And that is really the crux of the problem in heart failure preserved EF: these patients come in, volume overloaded, needing hospitalization quite frequently. And so, if there's anything one can do to reduce those numbers of hospitalizations, it is clinically very important.