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Hot Line - Finerenone reduces CV and renal risk across the CKD spectrum in patients with type 2 diabetes mellitus

28 Aug 2021
Hot Line presented at ESC Congress

In 2020, the FIDELIO-DKD trial reported that the non-steroidal mineralocorticoid receptor antagonist (MRA) finerenone slowed progression of chronic kidney disease (CKD) and improved cardiovascular (CV) outcomes in patients with predominantly advanced CKD and type 2 diabetes mellitus (T2DM).1 Data from two Hot Line presentations today provide evidence to support the use of finerenone in patients with T2DM across CKD stages.

Professor Bertram Pitt (University of Michigan, Ann Arbor, USA) described results from the double-blind, phase III FIGARO-DKD trial, which compared finerenone with placebo in patients with T2DM and mild-to-moderate CKD, defined as a urine albumin-to-creatinine ratio (UACR) ≥30–<300 mg/g and an estimated glomerular filtration rate (eGFR) ≥25–≤90 mL/min/1.73 m2 or UACR ≥300–≤5,000 mg/g and eGFR ≥60 mL/min/1.73 m2. Eligibility criteria included receipt of optimised renin–angiotensin system blockade and serum potassium of ≤4.8 mmol/L.

A total of 7,437 patients were randomised 1:1 to receive once-daily oral finerenone (10 or 20 mg) or placebo. The mean age was 64.1 years and 69.4% were male. The primary endpoint was a composite of time to CV death, non-fatal myocardial infarction, non-fatal stroke or hospitalisation for HF. With a median follow-up of 3.4 years, finerenone was associated with a 13% reduction in the risk of the primary endpoint compared with placebo (12.4% vs. 14.2%; hazard ratio [HR] 0.87; 95% confidence interval [CI] 0.76 to 0.98; p=0.03). The CV benefit was driven largely by a 29% reduction in HF hospitalisation.

The key secondary endpoint of kidney failure, sustained eGFR decline of ≥40% from baseline or renal death was reported in 9.5% of patients receiving finerenone and 10.8% receiving placebo (HR 0.87; 95% CI 0.76 to 1.01; p=0.07).

Regarding other secondary outcomes, the composite of kidney failure, sustained eGFR decline of ≥57% from baseline or renal death occurred in 2.9% and 3.8% patients in the finerenone and placebo groups, respectively (HR 0.77; 95% CI 0.60 to 0.99). End-stage kidney disease occurred in 0.9% and 1.3% patients in the finerenone and placebo groups, respectively (HR 0.64; 95% CI 0.41 to <1.00).

Hyperkalaemia was about twice as common with finerenone as with placebo (10.8% vs. 5.3%), but the corresponding proportions of patients discontinuing study drug were low (1.2% vs. 0.4%).

Individual patient data from FIGARO-DKD and from FIDELIO-DKD were combined in the prespecified FIDELITY meta-analysis, as presented by Professor Gerasimos Filippatos (National & Kapodistrian University of Athens Medical School, Greece).

Median follow-up was 3.0 years in the 13,026 patients analysed. Finerenone reduced the risk of the primary CV composite endpoint by 14% compared with placebo (12.7% vs. 14.4%; HR 0.86; 95% CI 0.78 to 0.95; p=0.0018). Finerenone also led to a 23% reduction in the risk of the renal composite endpoint of kidney failure, sustained eGFR decline of ≥57% from baseline or renal death (5.5% vs. 7.1%; HR 0.77; 95% CI 0.67 to 0.88; p=0.0002). The benefit of finerenone was observed across the individual renal components, except for renal death, which had too few events to enable treatment comparisons.

Safety outcomes were generally similar between treatments. The incidence of hyperkalaemia with finerenone was approximately double that with placebo (14.0% vs. 6.9%). However, hypokalaemia-related permanent treatment discontinuation was infrequent (1.7% with finerenone vs. 0.6% with placebo).

Summarising the findings, Prof. Filippatos commented, “The FIDELITY analysis demonstrates that finerenone reduced the risk of CV and kidney outcomes compared with placebo across the spectrum of CKD in patients with T2DM. The CV benefits of the drug were consistent across eGFR and UACR categories, indicating that treatment should be initiated in the early stages of renal disease.”


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1. Bakris GL, et al. N Engl J Med. 2020;383:2219–2229.