medwireNews: Finerenone reduces the risk for new-onset heart failure (HF), as well as hospitalization for heart failure (HHF) and death from HF, in people with type 2 diabetes and albuminuric chronic kidney disease (CKD), the latest analysis of FIGARO-DKD study data show.
The benefits of treatment with the selective, nonsteroidal mineralocorticoid receptor antagonist (MRA), relative to placebo, were apparent regardless of a previous history of HF and “can be expected to translate into meaningful improvements in patient outcomes,” write Gerasimos Filippatos (Attikon University Hospital, Athens, Greece) and co-authors in Circulation.
Filippatos et al explain the phase 3 FIGARO-DKD trial primarily showed that finerenone significantly improved the composite cardiovascular (CV) outcome of time to CV death, nonfatal myocardial infarction, nonfatal stroke, or HHF compared with placebo in patients with type 2 diabetes and albuminuric CKD.
In the current, prespecified analysis, the researchers looked at the impact of finerenone on clinically important HF outcomes among the 7352 study participants. Of these, 7.8% had a history of HF at baseline and all were on a maximum tolerated dose of renin–angiotensin system inhibitor therapy.
They report that, during a median 3.4 years of follow-up of participants without HF, the incidence of new-onset HF was significantly lower among the 3396 participants who received finerenone (10 mg or 20 mg depending on their estimated glomerular filtration) than among the 3385 who received placebo, at 1.9% versus 2.8%. This corresponded to a 32% lower risk in favor of finerenone.
At month 48, the absolute risk reduction for new-onset HF with finerenone was 1.1% according to Kaplan–Meier estimates, which the researchers say is equivalent to a number needed to treat of 91 to prevent one such event.
In the overall population, the risks for a first HHF, a first HHF or HF death, and a first HHF or CV death were a significant 29%, 32%, and 18% lower, respectively, with finerenone versus placebo.
Similarly, the risks for all HHF, all HHF or HF death, and all HHF or CV death, were a significant 30%, 30%, and 21% lower, respectively, among the patients who received finerenone compared with those who received placebo.
Filippatos and team note that although participants with a history of HF had a higher incidence of all HF-associated outcomes, having previous HF did not modify the effect of finerenone on the composite outcomes.
The investigators also report that “finerenone was generally well tolerated, with overall balanced treatment-emergent [adverse events] between treatment groups.”
The incidence of hyperkalemia was higher with finerenone than placebo in individuals with (8.3 vs 4.6%) and without (11.0 vs 5.3%) a history of HF, but few cases led to discontinuation (0.3 vs 0.7% and 1.3 vs 0.3%, respectively).
Filippatos and colleagues conclude that FIGARO-DKD “is the first study to show that an MRA, specifically the selective nonsteroidal MRA finerenone, may prevent the development of HF in patients with CKD and [type 2 diabetes].”
And they suggest that “screening for albuminuria and early treatment of patients with CKD and [type 2 diabetes] is important to reduce HF burden in this patient population.”
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