FIGARO-DKD and FIDELITY Findings Show Benefits of Finerenone to Improve Outcomes in Patients With Kidney Disease, Diabetes

Two separate studies out of ESC Congress 2021 – FIGARO-DKD and FIDELITY – add to the growing body of evidence addressing the use of finerenone to improve outcomes in patients with kidney disease and diabetes.

In FIGARO-DKD, the findings of which were also published in the New England Journal of Medicine, finerenone reduced the risk of cardiovascular morbidity and mortality in patients with mild to moderate kidney disease and type 2 diabetes. Researchers randomized a total of 7,437 patients in 48 countries to either oral finerenone (10 or 20 mg) or placebo once daily. The average age was 64.1 years and 69.4% were men. The primary endpoint was a cardiovascular composite of time to cardiovascular death, nonfatal myocardial infarction, nonfatal stroke or hospitalization for heart failure. Patients with symptomatic chronic heart failure with reduced ejection fraction were excluded.

Results showed the primary endpoint occurred in 12.4% of patient (n=458) in the finerenone group compared with 14.2% patients (n=519) in the placebo group. Researchers noted that the relative risk of this endpoint was significantly reduced by 13% with finerenone versus placebo. Additionally, the overall frequency of adverse events did not differ between the groups, they said. The key secondary outcome – a composite of kidney failure, renal death, or sustained decrease in estimated glomerular filtration rate (eGFR) by 40% or more from baseline – occurred in 9.5% and 10.8% of patients in the finerenone group and the placebo group, respectively. End-stage kidney disease occurred in 0.9% of patients in the finerenone group and 1.3% of patients in the placebo group. In other findings, hyperkalemia was increased with finerenone (10.8%) compared to placebo (5.3%), but subsequent discontinuation of the study drug was low (1.2% with finerenone vs. 0.4% with placebo).

"The benefits of finerenone were consistent across eGFR and urine albumin-to-creatinine ratio (UACR) categories," said study author Bertram Pitt, MD, FACC. "Together with FIDELIO-DKD, the results support the use of finerenone to improve cardiorenal outcomes across the spectrum of kidney disease and type 2 diabetes."

Results from FIDELITY, a pre-specified metanalysis combining individual patient data from FIDELIO-DKD and FIGARO-DKD, found finerenone to reduce the risk of cardiovascular and renal outcomes compared to placebo in patients with type 2 diabetes and all stages of kidney disease.

"More than 13,000 patients were included in this analysis, enabling more robust estimates of the cardiorenal efficacy and safety of finerenone than either trial alone," said study author Gerasimos Filippatos, MD. "In addition, the analysis encompassed the full range of kidney disease severity experienced by patients with type 2 diabetes."

Overall, the analysis found the composite cardiovascular endpoint occurred in 12.7% of patients receiving finerenone (n=825) and 14.4% of patients receiving placebo (n=939). Finerenone reduced the risk of this outcome by 14% compared with placebo, study authors said. All components of the composite kidney outcome were significantly lower with finerenone than placebo, except renal death which occurred too infrequently to make a comparison between groups, researchers said. No significant differences were observed in safety outcomes among both treatment arms, with the exception of hyperkalemia which was more common with finerenone (14.0%) than placebo (6.9%).

"The FIDELITY analysis demonstrates that finerenone reduced the risk of cardiovascular and kidney outcomes compared with placebo across the spectrum of chronic kidney disease in patients with type 2 diabetes," Filippatos said. "The cardiovascular benefits of the drug were consistent across eGFR and UACR categories, indicating that treatment should be initiated in the early stages of renal disease."

Clinical Topics: Diabetes and Cardiometabolic Disease, Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: ESC Congress, ESC21, Renal Insufficiency, Chronic, Metabolic Syndrome, Heart Failure, Diabetes Mellitus, Type 2, ACC International

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