INDIANAPOLIS — Is chronic kidney disease (CKD)-associated cardiovascular risk in Type 2 diabetes (T2D) modifiable? The answer is unclear, according to a recent study.

That’s why researchers from Richard L. Roudebush VAMC and the Indiana University School of Medicine sought to determine whether cardiovascular risk can be modified with finerenone in patients with Type 2 diabetes and CKD. Results were published in JAMA Cardiology.1

The researchers combined incidence rates from Finerenone in Chronic Kidney Disease and Type 2 Diabetes: Combined FIDELIO-DKD and FIGARO-DKD Trial Programme Analysis (FIDELITY), a pooled analysis of two Phase 3 trials (including patients with CKD and T2D randomly assigned to receive finerenone or placebo) with National Health and Nutrition Examination Survey data to simulate the number of composite cardiovascular events that may be prevented per year with finerenone at a population level. Data were analyzed over four years of consecutive National Health and Nutrition Examination Survey data cycles (2015-2016 and 2017-2018).

The study estimated Incidence rates of cardiovascular events (composite of cardiovascular death, nonfatal stroke, nonfatal myocardial infarction or hospitalization for heart failure) over a median of 3.0 years by estimated glomerular filtration rate (eGFR) and albuminuria categories. The subanalysis included a 13 026 participants with a mean age of 64.8 and 69.8% male.

Results indicated that lower eGFR and higher albuminuria were associated with higher incidences of cardiovascular events. “For recipients in the placebo group with an eGFR of 90 or greater, incidence rates per 100 patient-years were 2.38 (95% CI, 1.03-4.29) in those with a urine albumin to creatinine ratio (UACR) less than 300 mg/g and 3.78 (95% CI, 2.91-4.75) in those with UACR of 300 mg/g or greater,” the researchers reported. “In those with eGFR less than 30, incidence rates increased to 6.54 (95% CI, 4.19-9.40) vs 8.74 (95% CI, 6.78-10.93), respectively.”

The study found that, in both continuous and categorical models, finerenone was associated with a reduction in composite cardiovascular risk (hazard ratio, 0.86; 95% CI, 0.78-0.95; P = 0.002) irrespective of eGFR and UACR (P value for interaction = 0.66).

“In 6.4 million treatment-eligible individuals (95% CI, 5.4-7.4 million), one year of finerenone treatment was simulated to prevent 38,359 cardiovascular events (95% CI, 31,741-44,852), including approximately 14,000 hospitalizations for heart failure, with 66% (25 357 of 38 360) prevented in patients with eGFR of 60 or greater,” the authors wrote.

The study concluded that, in the subanalysis of the FIDELITY trial, that CKD-associated composite cardiovascular risk might be modifiable with finerenone treatment in patients with T2D, those with eGFR of 25 or higher, and those with UACR of 30 mg/g or greater. “UACR screening to identify patients with T2D and albuminuria with eGFR of 60 or greater may provide significant opportunities for population benefits,” the researchers suggested.

 

  1. Agarwal R, Pitt B, Rossing P, Anker SD, et. al. Modifiability of Composite Cardiovascular Risk Associated With Chronic Kidney Disease in Type 2 Diabetes With Finerenone. JAMA Cardiol. 2023 Jun 14:e231505. doi: 10.1001/jamacardio.2023.1505. Epub ahead of print. PMID: 37314801; PMCID: PMC10267848.