Key result
Finerenone consistently reduces CV death and total HF events across all age groups.
Why the study?
Does finerenone reduce cardiovascular death and heart failure events compared to placebo in patients with HFmrHF/HFpEF across different age groups?
RCT (n=6,001)
Does finerenone reduce cardiovascular death and heart failure events compared to placebo in patients with HFmrHF/HFpEF across different age groups?
p-value: p=0.27
Finerenone safely and effectively reduces cardiovascular death and heart failure events in patients with HFmrHF/HFpEF, with consistent benefits and safety profile across all age groups.
Background: Finerenone improves outcomes in patients with HF and mildly reduced or preserved ejection fraction (HFmrHF/HFpEF). It is important to understand the efficacy and safety of finerenone in these patients according to age. Methods: The aim of this analysis was to evaluate the interaction between age and the efficacy and safety of finerenone in the FINEARTS-HF trial (Finerenone trial to investigate efficacy and safety compared to placebo in patients with heart failure). A total of 6,001 patients aged 40-97 years were stratified by quartile (Q 1-4) of baseline age: Q1 40-66 years (n=1,581), Q2 67-73 years (n=1,587), Q 3 74-79 years (n=1,421), and Q4 ≧ 80 years (n=1,412). FINEARTS-HF evaluated the impact of age on the efficacy of finerenone with respect to the primary composite outcome of cardiovascular death and total (first and recurrent) HF events, including HF hospitalization or urgent HF event, along with secondary efficacy and safety outcomes. Results: The incidence of primary outcome increased with age. Finerenone reduced the risk of the primary outcome consistently across all age categories: RR (95% CI) Q1 0.70 (0.53- 0.92), Q2 0.83 (0.64-1.07), Q3 0.98 (0.76-1.26), and Q4 0.85 (0.67-1.07); p for interaction =0.27. Similarly, a consistent effect was observed for the components of the primary outcome. The mean increase in Kansas City Cardiomyopathy Questionnaire-total symptom score from baseline to 12 months was greater with finerenone than placebo, with a consistent effect across all age categories: mean placebo-corrected change (95% CI) Q1 2.87 (1.09-4.66), Q2 1.24 (-0.59-3.07), Q3 0.94 (-0.98-2.86), and Q4 1.24 (-0.90-3.38); P-interaction=0.50. Adverse events were similar across all age categories. The odds of experiencing hypotension, elevated creatinine, or hyperkalemia (increased) or hypokalemia (decreased) related to finerenone did not differ by age. Conclusions: In the FINEARTS-HF trial, finerenone reduced the primary outcome and components of the primary outcome, and improved symptoms across a wide age spectrum. In addition, finerenone was safe and well-tolerated, irrespective of age. Trial Registration: URL: https://clinicaltrials.gov Unique Identifiers: NCT04435626 and EudraCT 2020-000306-29.
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Chimura et al. (2024) conducted an RCT in Heart failure with mildly reduced or preserved ejection fraction (HFmrHF/HFpEF) (n=6,001). Finerenone vs. Placebo was evaluated on Composite outcome of cardiovascular death and total (first and recurrent) HF events, including HF hospitalization or urgent HF event (p=0.27). Finerenone reduced the primary composite of CV death and total HF events consistently across age quartiles (RR ranging from 0.70 in Q1 to 0.85 in Q4; P-interaction=0.27).
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