FIDELIO-DKD Phase III study of BAY 94 8862 in CKD + T2D published in Circulation.- Bayer

Bayer announced late-breaking data from a pre-specified exploratory subgroup analysis of the FIDELIO-DKD Phase III study, in which the investigational drug BAY 94 8862 (finerenone), compared to placebo, reduced the risk of cardiovascular (CV) outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), with or without history of cardiovascular disease (CVD). In this pre-specified exploratory subgroup analysis of FIDELIO-DKD study of finerenone, researchers evaluated the secondary composite CV outcomes by patient history of CVD (Interaction p-0.85). Of the 2,605 patients with a history of CVD, the composite CV outcome occurred in 17.7 percent of patients in the finerenone group and 20.2 percent of patients in the placebo group (HR 0.85 [95% CI, 0.71–1.01]). For 3,069 patients without a history of CVD, the composite CV outcome occurred in 8.9 percent of patients in the finerenone group and in 10.2 percent of patients in the placebo group (HR 0.86; [95 percent CI, 0.68–1.08]). The findings were presented in a Late-Breaking session at the American Heart Association’s (AHA) Scientific Sessions 2020, and simultaneously published in Circulation.See: "Finerenone and Cardiovascular Outcomes in Patients with Chronic Kidney Disease and Type 2 Diabetes" Gerasimos Filippatos et al. Circulation. November 16 2020, https://doi.org/10.1161/CIRCULATIONAHA.120.051898