SAN DIEGO — In patients with heart failuretreatment with veneer provides some benefit in reducing the risk of macroalbuminuria. But no significant changes are observed in estimated glomerular filtration rate (eGFR)-based renal outcomes, an analysis of the recently published FINEARTS-HF trial shows.

“Among heart failure patients with mildly reduced or preserved ejection fraction in FINEARTS-HF, who were at relatively low risk of renal adverse events, finerenone did not change the rate of a prespecified renal composite outcome,” said first author Finnian R. McCausland, MB BCh, of Brigham and Women’s Hospital in Boston, Massachusetts, presented the findings at a press briefing for the American Society of Nephrology (ASN) Kidney Week 2024.

The analysis was simultaneously published in Journal of the American College of Cardiology.

“Finerenone caused an initial expected decrease in estimated glomerular filtration rate (eGFR), but did not alter the long-term eGFR trajectory, compared with placebo.”

In the recently published FINEARTS-HF trialshowed significant benefits in heart failure outcomes and cardiovascular mortality related to treatment with finerenone, a nonsteroidal mineralocorticoid receptor antagonist (MRA), in heart failure patients with mildly reduced or preserved ejection fraction.

Specifically, the study showed that finerenone reduced the primary endpoint of worsening heart failure events (unplanned hospitalization or emergency visit for heart failure) and death from cardiovascular causes by 16% compared with placebo (rate ratio, 0.84; P =.007).

With chronic kidney disease present in approximately 50% of heart failure patients with mildly reduced or preserved ejection fraction—and associated with higher morbidity and mortality in these patients—the authors further evaluated the drug’s renal effects in a prespecified analysis of the FINEARTS-HF population of 6,000 patients with heart failure and a left ventricular ejection fraction of 40% or more.

They found that, with a median follow-up of 2.6 years, those receiving finerenone had no significant differences compared to placebo in the composite renal outcome of 50% or more reduction in eGFR decline or renal failure, with low rates in both groups – 75 vs . 55 events (hazard ratio (HR) 1.33).

The differences were also not statistically significant for the outcome of having a 57% or greater eGFR decrease or renal failure (41 vs. 31 events; HR, 1.28).

Those treated with finerenone had significantly greater improvements in urine albumin-to-creatinine ratio (UACR), with a 30% greater reduction compared to placebo at 6 months, regardless of whether patients had diabetes.

“Taken together, these data provide important information about expected changes in renal biomarkers when prescribing finerenone for heart failure patients with mildly reduced or preserved ejection fraction,” McCausland said.

In the FINEARTS-HF study, participants were randomized 1:1 to treatment with finerenone, up to 20 mg or 40 mg once daily, or a matching placebo, in addition to standard therapy.

Key exclusion criteria included having an eGFR of < 25 mL/min/1.73 m²potassium level > 5.0 mmol/L, hemoglobin < 10 g/dL or symptomatic hypotension.

Patients had a mean baseline eGFR of 62 mL/min/1.73 m²with approximately half (48%) having a mean baseline eGFR of less than 60 ml/min/1.73 m²indicating moderate to severe kidney disease.

Baseline UACR data were available for 5797 participants, who had a median UACR of 18 mg/g.

While 61% had a baseline UACR of less than 30 mg/g, 30% had levels of 30 to less than 300 mg/g, indicating albuminuria, and 10% had macroalbuminuria, with UACR levels of 300 mg/g or higher.

Despite the lack of a significant difference in the renal composite score, the current analysis showed that among participants with UACR levels below 300 mg/g, finerenone treatment reduced the risk of new-onset macroalbuminuria by 38% (HR, 0.62), regardless of their diabetes status.

Note that those treated with the finerenone group had increased hyperkalemia episodes, with similar patterns across eGFR categories.

Commenting on the study, Emily Chang, MD, an associate professor of medicine in the Department of Nephrology and Hypertension at the University of North Carolina, Chapel Hill, noted that “it’s good to have these more diverse tools that can help, depending on what the underlying problems are—whether it’s high blood pressure, diabetes, or heart failure—and the more we can take find out which of these medications help, it will really help doctors prioritize this patient.

“Studies like this are very beneficial in moving the needle a little more in our understanding of each of these tools,” she said Medscape Medical News.

Ian de Boer, MD, professor of medicine and endowed chair in renal research at the University of Washington in Seattle, commented on the study as a session discussant, noting the relatively low renal risk in the study population and adding that “chronic kidney disease is a disease that naturally progresses over years to decades, and (the study) has a relatively short follow-up of the long-term effects in this population.”

Nevertheless, an important contribution of the FINEARTS-HF trial is that “we now know that despite no major renal benefits in this population, there are heart failure benefits, and this will lead to an increased use of finerenone in this population.

“There is already debate in the cardiology field about whether to use a nonsteroidal or steroidal mineralocorticoid receptor antagonist in this population, (but) I think most people agree that having a new tool to treat moderately reduced and preserved ejection fraction.” he said.

McCausland reported relationships with GlaxoSmithKline, Zydus Therapeutics, and research funding from Novartis and Lexicon. De Boer’s disclosures include relationships with Alnylam, AstraZeneca, Boehringer Ingelheim, Dexcom, Lexicon, Lilly, Miter and Novo Nordisk.