An analysis of secondary end points from FIGARO-DKD presented at Kidney Week 2021 provides further insight into the effects of finerenone on kidney outcomes, including a 36% reduction in need for dialysis.
An analysis of secondary outcomes data from the FIGARO-DKD trial is providing clinicians with further insight into effects of finerenone (Kerendia) on kidney outcomes in patients with type 2 diabetes and chronic kidney disease (CKD).
Presented at the American Society of Nephrology (ASN) Kidney Week 2021, results of the analysis demonstrate use of finerenone was associated with reductions in risk of both secondary renal end points examined, including a 23% reduction in risk of eGFR declines of 57% or more and a 36% reduction in need for dialysis, compared to placebo therapy.
“If you're a cardiologist and you're not dipping urine, you're missing a whole host of cardiovascular risk because presence of kidney disease is a cardiovascular risk factor,” said George Bakris, MD, professor of medicine at the University of Chicago, in an interview with Endocrinology Network.
With a similar design to FIDELIO-DKD, with the exception of including patients with less advanced CKD, FIGARO-DKD was designed with a composite primary outcome of cardiovascular events and secondary kidney outcomes to provide an overview of the effects across the spectrum of CKD in type 2 diabetes. The specific inclusion criteria for FIGARO-DKD were a diagnosis of type 2 diabetes, UACR of 30 to less than 300 mg/g and an eGFR 25–90 mL/min/1.73 m2 or UACR ≥300–≤5000 mg/g and eGFR ≥60 mL/min/1.73 m2, optimized renin–angiotensin system blockade, and screening serum potassium equal to or less than 4.8 mEq/L.
The key secondary outcome of the trial was an eGFR 40% composite of time to kidney failure, sustained eGFR decline of 40% or more from baseline, or renal death. Additional secondary outcomes of interest included change in UACR from baseline to month 4 and another composite renal endpoint exchanging a sustained 40% eGFR decline with a 57% or greater decline.
Overall, 7352 patients were included in the analysis, which is the same amount included in the final analyses of the overall trial. This patient population had a mean age of 64.1±9.8 years, 69.4% were men, and a mean eGFR was 67.8±21.7 mL/min/1.73m2.Investigators pointed out 62% of patients had a baseline eGFR at or above 60 mL/min/1.73m2 and 49% had a baseline UACR less than 300 mg/g.
During a median follow-up of 3.4 years, 9.5% of patients randomized to finerenone and 10.8% randomized to placebo experienced the 40% eGFR composite endpoint (HR, 0.87 [95% CI, 0.76-1.01]; P=.069). Analysis of other secondary end points revealed finerenone use was associated with a clinically meaningful prolonging of time to the 57% eGFR decline composite end point (HR, 0.77 [95% CI, 0.60-0.99]) and a greater reduction in UACR at month 4 was observed with finerenone use compared with placebo therapy (ratio of least-squares means 0.68 [95% CI 0.65–0.70]).
“So, the take-home message is, if you're a cardiologist, measure the urine and see if there's a lot of albuminuria. If there is, and at least they’re treated with finerenone, you're going to not only get a benefit on cardiovascular risks, specifically hospitalization for heart failure, but you're also going to get a benefit on reducing kidney disease progression to the point where you're going to reduce dialysis,” Bakris added.
This study, “Finerenone and Kidney Outcomes in Patients with CKD and Type 2 Diabetes: Results from FIGARO-DKD,” was presented at ASN Kidney Week 2021.