In patients with heart failure with mildly reduced and preserved ejection fraction, finerenone reduced the risk of heart failure worsening or hospitalizations compared with placebo, explained John McMurray, MD, the co–principal investigator of the FINEARTS-HF trial.
The FINEARTS-HF trial found finerenone reduced the risk of heart failure worsening and hospitalizations in patients with heart failure with mildly reduced and preserved ejection fraction, explained coprincipal investigator of the FINEARTS-HF clinical trial, John McMurray, MD, professor of Medical Cardiology at the University of Glasgow in Scotland and the United Kingdom, and chair of the 2024 European Society of Cardiology (ESC) Congress.
Can you outline the key findings from the FINEARTS-HF clinical trial presented at the ESC Congress?
FINEARTS was a large trial. There were about 6001 patients enrolled—nearly equal numbers of men and women—and the patients had heart failure with mildly reduced and preserved ejection fraction. So what that means is they had an ejection fraction of 40% or above. So that's a group of patients where, until very recently, we've had no evidence-based treatment, and most of our therapy has been empirical.
So, we studied a new type of mineralocorticoid receptor antagonist [MRA], or aldosterone antagonist, a nonsteroidal MRA finerenone, [and] compared that to placebo in these patients, and the randomized treatment was added to usual care. Our primary end point was a composite of total worsening heart failure events. So, that means first as well as subsequent events. And by worsening heart failure event, I mean either admission to hospital because of worsening heart failure or worsening heart failure that was treated in an ambulatory care setting that didn't lead to hospital admission, but required intravenous therapy.
And we found that finerenone compared to placebo, reduced the risk of that primary composite end point by 16%, that was the relative risk reduction. The main effect was on heart failure hospitalizations, and there was an 18% relative risk reduction in total heart failure hospitalizations with some other end points. Probably the one that matters most to patients is that we measured the Kansas City Cardiomyopathy Questionnaire, total symptom score. The KCCQ is a patient-reported outcome. So, the patients fill in a questionnaire, and we saw a significant improvement in that with finerenone compared to placebo.
Overall, finerenone was well tolerated. There were some expected adverse events. So, we saw a bit more hyperkalemia—so, high potassium—and we saw less hypokalemia—low potassium. We also saw more patients who had a rise in serum creatinine concentration. And we saw that patients who were randomized to finerenone were more likely to have a lower blood pressure than patients randomized to placebo. But none of those adverse events were frequent or commonly led to treatment discontinuation.
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