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New FINEARTS-HF data shows that finerenone reduces albuminuria in patients with HFmrEF or HFpEF, but without significant eGFR changes.
New data from the FINEARTS-HF trial is shedding light on the effects of finerenone (Kerendia) on kidney outcomes among patients with heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF).
Presented at the American Society of Nephrology’s Kidney Week 2024, results of the prespecified analysis demonstrate use of finerenone did not alter eGFR-based kidney outcomes but was associated with but led to early and sustained reductions in albuminuria and reduced the risk of new-onset of macroalbuminuria.1,2
“We observed that, although finerenone led to an initial decline in kidney function measurements, longer-term kidney function patterns were similar to those receiving placebo,” said presenting investigator Finnian R. McCausland, MBBCh, assistant professor of Medicine and director of the Master of Medical Sciences in Clinical Investigation program at Harvard Medical School and Brigham and Women’s Hospital.2 “We also noted that finerenone reduced the amount of protein leaked by the kidneys, which is thought to be predictive of better patient outcomes.”
Finerenone received approval for use in chronic kidney disease in patients with type 2 diabetes in July 2021. Since this approval, the agent has made waves for its cardiovascular benefits. First for a label expansion to reflect cardiovascular outcomes benefits in September 2022 and, most recently, for revelations of paradigm-shifting heart failure benefits in the FINEARTS-HF trial at ESC Congress 2024.1,2,3
A global, randomized, placebo-controlled clinical trial of finerenone among patients diagnosed with New York Heart Association class II-IV heart failure, an LVEF of 40% or greater, and receiving diuretic treatment for at least 30 days prior to randomization. The trial randomized 2998 and 3003 patients to placebo and finerenone, respectively, and followed them for a primary composite endpoint of cardiovascular death and total heart failure events.1,3
In the overall trial, use of finerenone was associated with a statistically significant 16% relative reduction in rate of primary outcome events compared with placebo therapy (rate ratio [RR], 0.84; 95% confidence interval [CI], 0.74 to 0.95; P = .007). Additional data from ESC Congress 2024 demonstrated there was no statistically significant differences between the finerenone and placebo groups for all-cause mortality (HR, 0.93; 95% CI, 0.83 to 1.06) or the composite kidney outcome (HR, 1.33; 95% CI, 0.94 to 1.89).3
At ASN Kidney Week 2024, McCausland presented data from a prespecified analysis of the effects on sustained 57% or greater eGFR decline or kidney failure and changes in UACR. Of the 6001 patients included in the trial, 5797 had baseline UACR data. Among this group the median baseline UACR was 18 (IQR, 7 to 67) mg/g, with 61% having a UACR less than 30mg/g and 10% with values equal to or exceeding 300mg/g.1,2
During the follow-up period, which lasted a median of 2.6 years, investigators found no statistically significant difference in rate of a 57% or greater eGFR decline or kidney failure with use of finerenone, noting what they considered low event rates with just 41 events occurring in the finerenone arm and 31 in the placebo arm (HR, 1.28; 95% CI, 0.80 to 2.05). Further analysis suggested use of finerenone was associated with a 30% reduction in UACR by 30% (95% CI, 25% to 34%) relative to placebo at 6 months, which investigators highlighted persisted throughout follow-up and irrespective of diabetes (P for interaction = .48).1
In a subgroup analysis of patients with a baseline UACR of 300 mg/g, results indicated use of finerenone was associated with a 38% relative risk reduction for new-onset macroalbuminuria (HR, 0.62; 95% CI, 0.53 to 0.73), irrespective of diabetes status.1
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