Efficacy of Finerenone Around Recent Worsening Heart Failure

Patients who were recently hospitalized or had recent worsening heart failure are particularly attractive targets to receive finerenone, based on a subanalyses of FINEARTS-HF, explained Akshay Desai, MD, medical director, Cardiomyopathy and Heart Failure Program, Advanced Heart Disease Section, Brigham & Women’s Hospital, and associate professor, Harvard Medical School.

[Editor’s note: Desai spoke with The American Journal of Managed Care^® ahead of the Heart Failure Society (HFSA) of American Annual Scientific Meeting, where the data were originally being released. However, the HFSA meeting was cancelled shortly before the start due to Hurricane Helene affecting the Atlanta area.]

This transcript has been lightly edited for clarity.

Transcript

How do the results of FINEARTS-HF add to the treatment landscape for patients with heart failure and mildly reduced or preserved ejection fraction? And how do the latest data add to the primary results presented earlier this year?

I think to start, FINEARTS-HF, the primary results were presented at the European Society of Cardiology meeting, and this was, to remind the audience, a trial of the nonsteroidal mineralocorticoid receptor antagonist finerenone vs placebo, a prospective randomized multicenter trial in patients with heart failure and either mildly reduced or preserved ejection fraction, not reduced ejection fraction. So, an ejection fraction more than 40%. This is a population where, historically, until recently, we've not had a lot of effective medical therapy.

More recently, we've seen great efficacy of SGLT2 inhibitors and for patients with at least [ejection fraction] below the range of normal angiotensin receptor neprilysin inhibitors. And this trial, which was presented by Scott Solomon, MD, at the European Society of Cardiology meeting and published in the New England Journal of Medicine, highlighted that treatment with finerenone was associated with improvements in the primary composite outcome of total worsening heart failure events and cardiovascular death. The reduction was about 16%. Most of that was driven by a reduction in worsening heart failure events—both in patient and ambulatory settings—without a specific improvement in cardiovascular death.

So, what was interesting about that trial is that the effects were consistent across the spectrum of ejection fraction and across almost all of the subgroups examined. And this offers, potentially, a new opportunity and new evidence supporting the role of treatment with at least finerenone in patients with heart failure and preserved ejection fraction, perhaps more broadly applicable to use of mineralocorticoid receptor antagonists in general in that population. I think what we are adding at this Heart Failure Society of America meeting is additional data from key subgroups of the FINEARTS-HF trial, and you have heard information at this meeting regarding the role of finerenone across the spectrum of ejection fraction. That data were presented by John McMurray, MD.

The presentation that I've given has focused principally on the effects of finerenone in patients with a recent worsening heart failure event. We know that patients who've had recent worsening heart failure, whether in the hospital or out of hospital, are at very high risk for subsequent mortality and readmission, particularly in the few weeks right after the worsening heart failure event. And so in that high-risk interval, we think there might be a particular opportunity for disease-modifying therapies, but we also have some concerns about safety of those therapies in that very dynamic posthospitalization or post–worsening heart failure environment.

And so, our data examine the treatment efficacy of finerenone in relation to the proximity to a worsening heart failure event. That trial enrolled patients in hospital or recently hospitalized patients and also chronic, ambulatory patients with heart failure. About half of the population had been enrolled within 3 months of a worsening heart failure event. What we found was that the treatment effect of finerenone was consistent in patients regardless of the time from worsening heart failure. And in fact, there seemed to be a numerically greater treatment effect, particularly when measured in absolute terms, in the patients who were enrolled in hospital or early after hospitalization, within the first 7 days.

So, what this suggests is that the treatment effect of finerenone is at least as effective, or at least as good, in patients who are enrolled in hospital or been recently hospitalized as those enrolled in stable ambulatory settings or those who've never had a worsening event. And it suggests that the safety in that setting is comparable to the setting in chronic care. I think this makes the recently hospitalized or recent worsening heart failure patient with mildly reduced or preserved ejection fraction a particularly attractive target for finerenone. This was a prespecified analysis, but these are secondary analyses that the trial wasn't designed to answer, and so a confirmation is needed in subsequent trials and there are a few of those ongoing with finerenone.