Bayer CKD New Drug Phase 3 Clinical Data: Significantly Reduced Risk of Complex Cardiovascular Events by 14%

Earlier this year, Bayer released positive top-line data from a key Phase 3 FIDELIO-DKD study for the treatment of chronic kidney disease (CKD) in patients with type 2 diabetes (T2D), showing that it can delay the on-stage occurrence of kidney disease and heart disease.
now, the company provides more details about Finerenone's ability to improve the health of people with these chronic diseases, regardless of their history of cardiovascular disease.
FIDELIO-DKD was a randomized, double-blind, placebo-controlled trial in which CKD combined with T2D patients.
these patients had a urine albumin-to-creatinine ratio of 30-5000mg/g, renal globular filtration rate (eGFR) ≥25 to <75ml/min/1.73m2, and were treated with an optimized nephrine-angiotensin system blocker.
patients with reduced shot blood fractions (HFrEF) were excluded.
study, patients were randomly grouped at a 1:1 scale and treated with finerenone or a placebo.
complex cardiovascular (CV) outcomes include cardiovascular death, myocardial infarction, stroke, or length of hospitalization for heart failure.
pre-designated CV analysis includes an analysis of the components in the compound outcome, as well as results based on the history of CV disease at baseline time.
results showed that between September 2015 and June 2018, 13,911 patients were screened and 5,674 patients were randomly grouped;
2.6 years of medium follow-up (four-point spacing: 2.0-3.4 years), finerenone significantly reduced the risk of compound CV event outcomes by 14% compared to placebo (HR=0.86; 95% CI:0.75-0.99; p=0.034), with and without C There was no significant interaction between patients with a history of V disease (in patients with a history of CV disease: HR:0.85; 95% CI: 0.71-1.01; in patients without a history of CV disease: HR=0.86,95%CI:0.68-1.08; Interaction p=0.85).
safety, the rates of adverse events (TEAEs) occurred during treatment between treatment groups were similar, with a lower rate of permanent drug suspension associated with high potassiumemia (2.3% in patients with a history of CV disease, 0.8% in the placebo group, and 2.2% in patients without a history of CV disease and 1.0% in the placebo group).
data confirmed that finerenone reduced the occurrence of complex CV outcomes in patients with CKD combined with T2D, and there was no evidence of differences in therapeutic outcomes based on past CV disease history.
finerenone Chemical Structure (Photo source: newdrugapprovals.org) Finerenone is a pioneering nonsteroidal, selective salt corticosteroid-like antagonist (MRA) that has been shown to reduce the harmful effects of overactivation of salt corticosteroids (MR).
overactivation of MR is a major driver of kidney and heart damage.
Five years ago, Bayer launched the Phase 3 finerenone project, which has so far included more than 13,000 patients in a number of late-stage clinical trials to study the effects of the drug on different aspects of cardiovascular and kidney disease, from early to late stage.
Currently, a number of Phase 3 clinical trials are under way, including FIGARO-DKD, which included approximately 7,400 patients with CKD combined T2D in 48 countries, including Europe, Japan, China and the United States, and is investigating the efficacy and safety of finerenone and placebo standard care in reducing CV morbidity and mortality, respectively, and data are expected to be available by the end of this year.
a placebo-controlled Phase 3 study, FINEARTS-HF, in another group of 5,500 patients, was designed to see if finerenone reduced the risk of CV death and heart failure hospitalization.
source: AHA: Bayer's finerenone helps kidney, heart disease patients regardlessless of medical history