Finerenone reduces worsening heart failure despite frailty status, industry trial finds
A favorable benefit-risk balance for finerenone in patients with frailty should challenge any clinical reluctance to introduce this new treatment in this patient population, wrote the authors of an industry-funded study.
Finerenone, a nonsteroidal mineralocorticoid receptor antagonist, reduced the risk of worsening heart failure (HF) events and cardiovascular deaths and improved symptoms in patients with heart failure with mildly reduced ejection fraction (HFmrEF) or HF with preserved ejection fraction (HFpEF) across a range of frail patients, an industry-funded study found.
Researchers conducted a prespecified secondary analysis of the phase 3 Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure (FINEARTS-HF), which involved 653 sites in 37 countries. Patients with New York Heart Association functional class II through IV heart failure, a left ventricular ejection fraction of 40% or higher, evidence of structural heart disease, and elevated natriuretic peptide levels were randomized to finerenone or placebo from September 2020 to January 2023.
Bayer AG funded the study. The steering committees of the trial designed and oversaw the study in collaboration with the sponsor, who had no role in the collection, management, analysis, and interpretation of data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. The study was published by JAMA on June 18.
Frailty index was calculated for 5,952 of 6,001 patients. Overall, 1,588 patients (26.7%) had class I frailty (not frail), 2,141 (36.0%) had class II frailty (more frail), and 2,223 (37.3%) had class III frailty (most frail). The effect of finerenone on the primary outcome (a composite of cardiovascular death and total HF events) did not vary significantly by frailty class (rate ratio, 1.07 [95% CI, 0.77 to 1.49] for class I, 0.66 [95% CI, 0.52 to 0.83] for class II, and 0.91 [95% CI, 0.76 to 1.07] for class II; P=0.77). The effects of finerenone on the components of the primary outcome, all-cause death, or improvement in the Kansas City Cardiomyopathy Questionnaire total symptom score did not vary by frailty class, nor did its effects on hypotension, creatinine level, or risk of hyperkalemia or hypokalemia.
The study authors concluded that finerenone reduced the risk of HF events and cardiovascular death and improved symptoms and that these effects were not modified by frailty status. “In keeping with findings from prior trials in HFmrEF and HFpEF, the benefit of finerenone on clinical outcomes was mainly driven by a reduction in worsening HF events,” the authors wrote, adding that “the finding that frailty status did not modify the beneficial effect of finerenone on worsening HF events is of great importance in frail individuals given the role of hospital admission in accelerating frailty.”