FIGARO-DKD - finerenone in type 2 diabetes and chronic kidney disease (CKD)
FIGARO-DKD investigated the effects of finerenone on CV and renal outcomes in patients with mild-to-moderate kidney disease and T2DM.
- 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
- average age was 64.1 years and 69.4% were men
- primary composite endpoint was time to CV death, nonfatal MI, nonfatal stroke, or HF hospitalization
- 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)
- effect was primarily driven by a 29% reduction in HF hospitalization.
- 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).
- 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).
- 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)
Study authors concluded:
- among patients with type 2 diabetes and stage 2 to 4 CKD with moderately elevated albuminuria or stage 1 or 2 CKD with severely elevated albuminuria, finerenone therapy improved cardiovascular outcomes as compared with placebo
- noted that:
- "..in this study, despite the exclusion of patients who had symptomatic heart failure with a reduced ejection fraction, hospitalization for heart failure was a key driver of the primary outcome..Because patients with CKD and type 2 diabetes who have new-onset or preexisting heart failure are at very high risk for hospitalization and death, treatment with finerenone may represent an advance in the prevention and management of heart failure, thus minimizing the considerable health care burdens in patients with CKD and type 2 diabetes.."
- noted that:
- Pitt B et al. Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes. NEJM August 28, 2021
Last edited 09/2021 and last reviewed 09/2021