LEVERKUSEN (dpa-AFX) - Bayer AG's (BAYZF.PK, BAYRY.PK, BYR.L) investigational drug finerenone reduced the risk of cardiovascular outcomes in patients with chronic kidney disease or CKD and type 2 diabetes, with or without history of cardiovascular disease, as per a pre-specified exploratory subgroup analysis of the FIDELIO-DKD Phase III study.
The FIDELIO-DKD data showed finerenone significantly reduced the risk of the key secondary endpoint, a composite of time to cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for heart failure compared to placebo by 14 percent over a median duration of follow-up of 2.6 years.
Of the 2,605 patients with a history of cardiovascular disease, the composite cardiovascular outcome occurred in 17.7 percent of patients in the finerenone group and 20.2 percent of patients in the placebo group.
For 3,069 patients without a history of cardiovascular disease, the composite cardiovascular outcome occurred in 8.9 percent of patients in the finerenone group and in 10.2 percent of patients in the placebo group.
FIGARO-DKD, the cardiovascular outcomes study with finerenone, is due to complete in mid-2021.
The Phase III program with finerenone in chronic kidney disease and type 2 diabetes enrolled more than 13,000 patients across a broad range of disease severity including those with early kidney damage and more advanced stages of kidney disease.
Copyright RTT News/dpa-AFX