Bayer announced that the study had met its primary endpoint. Full results are expected at a meeting in August.
The addition of finerenone to standard medical therapy significantly reduces the risk of cardiovascular mortality and other cardiovascular events in patients with chronic kidney disease (CKD) and type 2 diabetes. This emerges from the topline results of FIGARO-DKD announced this week.
Bayer, maker of the trialed mineralocorticoid receptor antagonist (MRA), announced that the large-scale study will meet its primary endpoint – reducing the risk of first-time CV mortality, MI, stroke, or heart failure – in approximately 7,400 patients randomized patients in the study.
The positive study is the second study to show a benefit of finerenone in patients with CKD and type 2 diabetes. In the FIDELIO-DKD study led by Dr. George Bakris (University of Chicago, IL) finerenone reduced the risk of kidney failure or death from kidney causes, the primary endpoint of the study, and the risk of CV mortality, MI, stroke, or heart failure hospitalization. In contrast to this study, FIGARO-DKD included patients with less severe CRF and type 2 diabetes.
The full results of the FIGARO-DKD study are expected to be presented at a major cardiology conference later this summer, most likely at the European Society of Cardiology Congress. Finerenone is currently being reviewed for approval by the European Medicines Agency and the US Food and Drug Administration based on the findings from FIDELIO-DKD.
The results of a pre-determined exploratory subgroup analysis of FIDELIO-DKD, which deals with the risk of new atrial fibrillation or flutter in patients with CRF and type 2 diabetes taking finerenone, are due next week during the final clinical study session of FIDELIO-DKD the scientific session of the American College of Cardiology 2021 will be published.
