Reduced CV outcomes with nonsteroidal MRA in patients with T2DM and mild-to-moderate CKD
FIGARO-DKD: finerenone in patients with chronic kidney disease and type 2 diabetes
Presented at the ESC congress 2021 by: Prof. Bertram Pitt, MD - Ann Arbor, MI, USA
Introduction and methods
The FIDELIO-DKD trial previously demonstrated that the nonsteroidal MRA finerenone had a significant positive effect on kidney and CV outcomes compared to placebo in patients with predominantly advanced kidney disease and T2DM. FIGARO-DKD is a companion trial to the prior FIDELKIO-DKD trial and investigated the effects of finerenone on CV and renal outcomes in patients with mild-to-moderate kidney disease and T2DM.
FIGARO-DKD enrolled 7437 patients from 48 countries. Included patients had T2DM and mild-to-moderate kidney disease, defined as UACR ≥30-<300 mg/g and eGFR ≥25-≤90 mL/min/1.73m² or UACR ≥300-≤5000 mg/g and eGFR ≥60 mL/min/1.73m². Patients were treated with optimized RAS blockade and had to have serum potassium levels ≤4.8 mmol/L at the run-in and screening visits. Patients with symptomatic chronic HFrEF were excluded. Patients were randomized in a 1:1 ratio to receive 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 composite endpoint was time to CV death, nonfatal MI, nonfatal stroke, or HF hospitalization. The key secondary outcome was the composite of kidney failure, sustained decrease in eGFR by ≥40% from baseline or renal death. Other secondary endpoints included the composite of kidney failure, sustained decrease in eGFR by ≥57% from baseline or renal death, and end-stage kidney disease. Median follow-up was 3.4 years.
- Finerenone significantly reduced the primary composite endpoint of time to CV death, nonfatal MI, nonfatal stroke, or HF hospitalization by 13%, compared to placebo (HR 0.87, 95%CI 0.76-0.98, P=0.026). This effect was primarily driven by a 29% reduction in HF hospitalization.
- The key secondary composite outcome of kidney failure, sustained decrease in eGFR by ≥40% from baseline or renal death was not significantly reduced by finerenone, compared to placebo (HR 0.87, 95%CI 0.76-1.01, P=0.069).
- The other secondary composite kidney outcome of kidney failure, sustained decrease in eGFR by ≥57% from baseline or renal death was significantly reduced by finerenone by 23%, compared to placebo (HR 0.77, 95%CI 0.60-0.99, P=0.041).
- End-stage kidney disease was also significantly reduced by finerenone, compared to placebo (HR 0.64, 95%CI 0.41-0.995, P=0.046).
- There was no difference in overall frequency of adverse events between the treatment groups. Hyperkalemia was observed more often in the finerenone group compared to the placebo group (10.8% vs. 5.3%), but discontinuation of study drug was low (1.2% in the finerenone group vs. 0.4% in the placebo group).
The nonsteroidal MRA finerenone significantly reduced the risk of CV outcomes in patients with mild-to-moderate kidney disease and T2DM treated with optimized RAS blockade.
-Our reporting is based on the information provided at the ESC Congress-