George Bakris, MD, offers further insight into the cardiovascular outcomes analysis of FIDELIO-DKD presented at AHA 2020.
After making a splash with the overall results at the American Society of Nephrology’s Kidney Week 2020, new data from an analysis of cardiovascular outcomes from FIDELIO-DKD is shedding additional light on the cardiorenal protection seen with finerenone.
Presented at the American Heart Association (AHA) Scientific Sessions 2020, results suggest the nonsteroidal, selective mineralocorticoid receptor antagonist finerenone was associated with a 14% reduction in negative cardiovascular outcomes and this effect was consistent regardless of baseline history of cardiovascular disease.
With a recent explosion in interest around antidiabetic agents with cardiorenal benefits, the results of the latest analysis highlight the potential of finerenone to fit into treatment algorithms.
A randomized, double-blind, placebo-controlled trial, FIDELIO-DKD enrolled more than 5600 patients with type 2 diabetes and meeting the criteria for chronic kidney disease and randomized them in 1:1 ratio to finerenone or placebo therapy. These patients were followed for a median of 2.6 years and overall results indicated finerenone lowered risk of worsening CKD by 18% (HR, 0.82; 95% CI, 0.73-0.93; P=.001) while also providing a 16%(HR, 0.86; 95% CI, 0.75-0.99; P=.034) reduction in a secondary endpoint of composite cardiovascular outcomes.
For the AHA 2020 analysis, investigators hoped to compare the effect of finerenone on individual cardiovascular outcomes of the study in those with and without cardiovascular disease at baseline. Of the 5674 patients randomized in the study, 2605 had cardiovascular disease at baseline—1303 randomized to finerenone and 1302 randomized to placebo. The composite cardiovascular outcome for the study included time to cardiovascular death, myocardial infarction, stroke, or hospitalization for heart failure.
Results of the analysis suggested use of finerenone was associated with reductions in risk of cardiovascular death (4.5% vs 5.3%; HR, 0.86; 95% CI, 0.68-1.08), nonfatal myocardial infarction (2.5% vs 3.1%; HR, 0.80; 95% CI, 0.68-1.08), and hospitalizations for heart failure (2.5% vs 3.1%; HR, 0.80; 95% CI, 0.58-1.09) when compared against placebo. Investigators pointed out a nonfatal stroke in 3.2% of finerenone patients and 3.1% of placebo patients (HR, 1.03; 95% CI, 0.76-1.38).
When comparing those with and without a history of cardiovascular disease, investigators found the effect of finerenone was not modified by prior cardiovascular disease (P for interaction=.85). Among those with cardiovascular disease, finerenone use was associated with a 15% reduction in risk of the composite cardiovascular outcome with an incidence rate of 7.18 per 100 patient-years versus 8.5 per 100 patients-years seen with placebo therapy (HR, 0.85; 95% CI, 0.71-1.01). Among those without cardiovascular disease, finerenone was associated with a 14% reduction in risk of the composite cardiovascular outcome with an incidence rate of 3.43 per 100 patient-years versus 3.92 per 100-patients years seen with placebo therapy (HR, 0.86; 95% CI, 0.68-1.08).
For more on the result of this analysis, we reached out to FIDELIO-DKD investigator George Bakris, MD, professor of medicine at the University of Chicago Medicine and member of Practical Cardiology’s editorial advisory board, to take part in an AHA 2020 House Call.
This study, “Finerenone and cardiovascular outcomes in patients with chronic kidney disease and type 2 diabetes,” was presented at AHA 2020 and simultaneously published in Circulation.