Finerenone in heart failure and chronic kidney disease with type 2 diabetes: FINE-HEART pooled analysis of cardiovascular, kidney and mortality outcomes.
In a prespecified participant-level pooled analysis of three trials (FINE-HEART; 18,991 participants), finerenone reduced all-cause mortality, heart failure hospitalization, and the composite kidney outcome, though the reduction in cardiovascular death did not reach statistical significance.
Background
Cardiovascular-kidney-metabolic syndrome links cardiovascular disease, chronic kidney disease, and diabetes. The non-steroidal mineralocorticoid receptor antagonist finerenone was studied in three prospective randomized trials (FIDELIO-DKD, FIGARO-DKD, and FINEARTS-HF), and given the overlap across these conditions, the authors pooled the data to summarize efficacy and safety on cardiovascular, kidney, and mortality outcomes.
Study design
FINE-HEART was a prespecified participant-level pooled analysis of the three trials, including 18,991 participants (mean age 67 years; 35% women) followed for a median of 2.9 years. The primary outcome was cardiovascular death, with additional outcomes including all-cause death, hospitalization for heart failure, and a composite kidney outcome.
Key findings
Cardiovascular death occurred in 4.4% of finerenone participants versus 5.0% on placebo (HR 0.89; 95% CI 0.78-1.01; P=0.076), which was not statistically significant. Death from any cause was lower with finerenone (11.0% vs 12.0%; HR 0.91; 95% CI 0.84-0.99; P=0.027), as were heart failure hospitalization (HR 0.83; 95% CI 0.75-0.92; P<0.001) and the composite kidney outcome (HR 0.80; 95% CI 0.72-0.90; P<0.001).
Clinical implications
While the reduction in cardiovascular death was not statistically significant in this pooled analysis, finerenone reduced the risks of all-cause death, cardiovascular events, and kidney outcomes, supporting its role across the cardiovascular-kidney-metabolic spectrum.
Category
Research
Source
Nat Med
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