Highlights from

AHA 2020

American Heart Association’s Scientific Sessions

Virtual 13 - 17 November 2020

Finerenone lowers CV events in diabetic CKD patients

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 which 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 randomised 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 hospitalisation 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, hyperkalaemia-related adverse events were twice as frequent in the finerenone group (18.3%) versus the placebo group (9.0%) and the frequency of hyperkalaemia 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.

  1. Filippatos G, et al. Finerenone and Cardiovascular Outcomes in Patients With Chronic Kidney Disease and Type 2 Diabetes. LBS.07, Virtual AHA Scientific Sessions 2020, 13-17 Nov.
  2. 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.

Top image: @ iStockPhoto: Noctiluxx

The content and interpretation of these conference highlights are the views and comments of the speakers/authors.