Finerenone decreased coronary heart failure (HF) occasions and cardiovascular demise in sufferers with HF and mildly decreased (HFmrEF) or preserved ejection fraction (HFpEF), in keeping with late-breaking analysis offered in a Scorching Line session as we speak at ESC Congress 2024.
Explaining the rationale behind the trial, Principal Investigator, Professor Scott Solomon of the Brigham and Girls’s Hospital, Boston, USA, stated: “Sodium-glucose co-transporter 2 (SGLT2) inhibitors are the one remedy for HFmrEF/HFpEF with a powerful guideline suggestion and there stays a excessive unmet want for extra therapies to enhance morbidity and mortality on this giant affected person inhabitants. Steroidal mineralocorticoid receptor antagonists (MRA) have confirmed advantages in HF with decreased ejection fraction (HFrEF), however their efficacy in HFmrEF/HFpEF has not been conclusively established. We investigated the non-steroidal MRA, finerenone, in sufferers with HFmrEF/HFpEF within the FINEARTS-HF trial, and a major constructive influence on outcomes was noticed.”
FINEARTS-HF was a double-blind, randomized trial in sufferers with HF (New York Coronary heart Affiliation [NYHA] practical class II-IV) and left ventricular ejection fraction (LVEF) of 40% or better. Extra inclusion standards included age 40 years or older, elevated natriuretic peptides and proof of structural coronary heart illness.
Eligible sufferers had been randomly assigned (1:1) to finerenone (as much as 40 mg as soon as day by day relying on baseline estimated glomerular filtration price [eGFR]) or placebo. The first endpoint was a composite of whole (first and repeat) worsening HF occasions and cardiovascular demise. Secondary endpoints included all-cause mortality and a composite kidney final result (sustained 50% or better decline in eGFR, sustained decline in eGFR to lower than 15 ml/min/1.73 m2 or initiation of persistent dialysis or kidney transplantation).
In whole, 6,001 sufferers had been randomized from greater than 650 websites throughout 37 international locations. The imply age was 72 years and 46% had been ladies. The imply LVEF was 53%, the bulk had NYHA class II HF (69%) and 20% of sufferers had been enrolled throughout or inside 7 days of a worsening HF occasion.
Over a median of 32 months, finerenone considerably decreased the first endpoint, with 1,083 occasions within the finerenone group and 1,283 occasions within the placebo group (price ratio 0.84; 95% confidence interval [CI] 0.74-0.95; p=0.007). A major discount in whole worsening HF occasions was noticed with finerenone in contrast with placebo (842 vs. 1,024 occasions; price ratio 0.82; 95% CI 0.71-0.94; p=0.006). Cardiovascular demise was non-significantly decreased within the finerenone arm (8.1% and eight.7%; hazard ratio [HR] 0.93; 95% CI 0.78-1.11). The first final result outcomes had been constant in all prespecified subgroups, together with these based mostly on ejection fraction or baseline use of SGLT2 inhibitors.
There was no distinction within the finerenone and placebo teams for all-cause mortality (16.4% and 17.4%, respectively; HR 0.93; 95% CI 0.83-1.06) or the composite kidney final result (2.5% and 1.8%, respectively; HR 1.33; 95% CI 0.94-1.89).
Severe hostile occasions had been comparable between the teams (finerenone: 38.7%; placebo: 40.5%). Finerenone elevated the chance of investigator-reported hyperkalemia (9.7% vs. 4.2%) however lowered the chance of hypokalaemia (4.4% vs. 9.7%).
The FINEARTS-HF trial gives the primary particular proof that an MRA is helpful in HFmrEF/HFpEF. We now have 4 pillars of guideline-directed medical remedy in HFrEF however solely SGLT2 inhibitors as a remedy possibility for HFmrEF/HFpEF. On condition that finerenone was helpful in sufferers already receiving an SGLT2 inhibitor, our findings level to finerenone as a brand new second pillar in HFmrEF/HFpEF.”
Professor Scott Solomon, Brigham and Girls’s Hospital, Boston, USA
