Finerenone treatment lowered the risk of chronic kidney disease (CKD) progression, as well as lowering the risk of cardiovascular events in patients diagnosed with type 2 diabetes and advanced CKD.
Prof. Gerasimos Filippatos (National and Kapodistrian University of Athens, Greece) described the effects of finerenone in the FIDELIO-DKD trial (NCT02540993) [1]. Results of the study were also reported in the New England Journal of Medicine [2].
Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist that reduces urinary albumin-to-creatinine ratio in patients with CKD previously treated with a renin-angiotensin system (RAS) inhibitor. The FIDELIO-DKD trial tested the efficacy of finerenone in slowing CKD progression and reducing cardiovascular (CV) events in patients diagnosed with advanced CKD and type 2 diabetes.
FIDELIO-DKD randomized 5,734 participants across 48 countries to receive either a once-daily dose of 20 mg oral finerenone or placebo. Adults with type 2 diabetes and CKD who were treated with a RAS inhibitor at the maximum dose were eligible. The primary endpoint was a composite of kidney failure, sustained estimated glomerular filtration rate (eGFR) decrease of at least 40% for at least 4 weeks, or death from renal causes. Kidney failure was defined as end-stage kidney disease with an eGFR <15 mL/minute/1.73m2.
After a median follow-up of 2.6 years, the primary endpoint had occurred in 504 participants in the finerenone group (17.8%) compared with 600 participants in the control group (21.1%; HR 0.82; 95% CI 0.73-0.93; P=0.001). The number of participants requiring finerenone treatment to prevent one primary outcome was 29 (95% CI 16-166). Additionally, death from CV causes, non-fatal myocardial infarctions, non-fatal stroke, or hospitalization due to heart failure occurred in 367 participants in the finerenone group (13.0%) compared with 420 participants in the placebo group (14.8%; HR 0.86; 95% CI 0.75-0.99; P=0.03).
Concerning safety, the incidence of serious adverse events was similar between both groups: 31.9% in the finerenone group and 34.3% in the placebo group. Specifically, hyperkalemia-related adverse events were twice as frequent in the finerenone group (18.3%) versus the placebo group (9.0%) and the frequency of hyperkalemia leading to treatment discontinuation was higher in the finerenone group (2.3%) compared with the placebo group (0.9%).
In conclusion, FIDELIO-DKD demonstrated that finerenone treatment lowered the risk of CKD progression and CV events in participants diagnosed with type 2 diabetes and advanced CKD.
- Filippatos G, et al. Finerenone and Cardiovascular Outcomes in Patients With Chronic Kidney Disease and Type 2 Diabetes.07, Virtual AHA Scientific Sessions 2020, 13-17 Nov.
- Bakris GL, et al. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. New Engl J Med 2020; Oct 23. DOI: 10.1056/NEJMoa2025845.
