European Society of Cardiology

European Society of Cardiology

Perspective from Ian de Boer, MD, MS
Perspective from Robert C. Stanton, MD
Source:

Pitt B, et al. Hot Line: FIGARO-DKD/FIDELITY Analysis. Presented at: European Society of Cardiology Congress; Aug. 27-30, 2021 (virtual meeting).


Disclosures: Filippatos reports financial relationships with Amgen, Bayer, Medtronic, Novartis, Servier and Vifor Pharma. Pitt reports financial relationships with AstraZeneca, Bayer, Boehringer Ingelheim, Brainstorm Medical, Cerano Scientific, G3 Pharmaceuticals, KBP Biosciences. Lexicon, PhaseBio, Proton Intel, Sanofi, Sarfez, scPharmaceuticals, SQ Innovation, Tricida and Vifor Pharma. Please see the studies for all other authors’ relevant financial disclosures.

August 28, 2021
3 min read
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Finerenone shows HF benefit in mild to moderate diabetic kidney disease: FIGARO-DKD

Perspective from Ian de Boer, MD, MS
Perspective from Robert C. Stanton, MD
Source:

Pitt B, et al. Hot Line: FIGARO-DKD/FIDELITY Analysis. Presented at: European Society of Cardiology Congress; Aug. 27-30, 2021 (virtual meeting).


Disclosures: Filippatos reports financial relationships with Amgen, Bayer, Medtronic, Novartis, Servier and Vifor Pharma. Pitt reports financial relationships with AstraZeneca, Bayer, Boehringer Ingelheim, Brainstorm Medical, Cerano Scientific, G3 Pharmaceuticals, KBP Biosciences. Lexicon, PhaseBio, Proton Intel, Sanofi, Sarfez, scPharmaceuticals, SQ Innovation, Tricida and Vifor Pharma. Please see the studies for all other authors’ relevant financial disclosures.

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The nonsteroidal mineralocorticoid receptor antagonist finerenone reduced CV event risk by 13% for adults with diabetic kidney disease compared with placebo, primarily driven by a 29% reduction in HF hospitalizations.

In an analysis of the FIGARO-DKD trial — a cohort of patients with less-severe renal disease than those in the companion FIDELIO-DKD trial — researchers also observed a nonsignificant but favorable trend for reduction in severe renal outcomes, including a reduction in the need for renal replacement therapy among participants in the finerenone (Kerendia, Bayer) arm.

Kidneys
Source: Adobe Stock

“Importantly, this was a very well-tolerated drug,” Bertram Pitt, MD, emeritus professor of medicine at the University of Michigan School of Medicine, said during a press conference at the European Society of Cardiology Congress. “As you would expect, there was hyperkalemia, but the people who had to stop because of hyperkalemia compared with placebo was less than 1%. You will never see that in this type of population with the steroidal mineralocorticoid receptor antagonists.”

Benefit in stable renal disease

As Healio previously reported, FIDELIO-DKD demonstrated finerenone delayed progression of CKD by reducing the combined risk for time to first occurrence of renal failure, defined as a sustained decrease of estimated glomerular filtration rate (eGFR) of at least 40% from baseline for at least 4 weeks, or renal death. Finerenone also reduced the risk for the key secondary endpoint, a composite of time to first occurrence of CV death, nonfatal MI, nonfatal stroke or HF hospitalization. Participants in FIGARO had less-severe renal disease compared with those in FIDELIO, Pitt said.

FIGARO-DKD was a double-blind trial that involved 7,437 adults with type 2 diabetes and stage 1-4 CKD who were randomly assigned oral finerenone 10 to 20 mg or placebo. Participants were treated with renin–angiotensin system blockade adjusted before randomization to the maximum tolerated dose.

The findings were simultaneously published in The New England Journal of Medicine.

During a median follow-up of 3.4 years, the primary outcome — a composite of CV death, nonfatal MI, nonfatal stroke or HF hospitalization — occurred in 12.4% of the finerenone group compared with 14.2% of the placebo group (HR = 0.87; 95% CI, 0.76-0.98; P = .03). The benefit was driven primarily by a lower incidence of hospitalization for HF (HR = 0.71; 95% CI, 0.56-0.9), according to the results.

Kidney failure, a sustained decrease of at least 40% from baseline in eGFR or renal death, a secondary outcome of the trial, occurred in 9.5% of the finerenone group compared with 10.8% of the placebo group (HR = 0.87; 95% CI, 0.76-1.01; P = .069).

There were no between-group differences in adverse events; however, the incidence of hyperkalemia-related discontinuation was higher with finerenone (1.2%) than with placebo (0.4%), Pitt said.

Albuminuria assessment ‘essential’

Pitt noted that 62% of participants in FIGARO-DKD had a normal eGFR that was over 60 mL/min/1.73 m2 despite evidence of an increase in urinary albumin-to-creatinine ratio — a group that may typically be ignored by cardiologists who only review the eGFR measurement and a group that has not been vigorously studied, he said.

“What we know from this study and other studies is that it is essential that you get a urine sample and if you have albuminuria, that patient has an increased risk, and now we know we can do something about it,” Pitt said. “There is tremendous opportunity to intervene early with a mineralocorticoid receptor antagonist — finerenone — and treat these patients.”

Prespecified meta-analysis, overall CV benefit

In a separate prespecified meta-analysis of individual patient data from FIDELIO and FIGARO (n = 13,171), in which 40% of participants had albuminuric CKD with preserved kidney function (mean eGFR, 57.6 mL/min/1.73 m2), researchers found that finerenone reduced risk for a composite CV outcome of time to CV death, nonfatal MI, nonfatal stroke or HF hospitalization by 14% compared with placebo (HR = 0.86; 95% CI, 0.78-0.95; P = .0018).

Finerenone also reduced risk for a composite renal outcome of a 57% or greater decline in eGFR, time to kidney failure or renal death by 23% compared with placebo (HR = 0.77; 95% CI, 0.67-0.88; P = .0002).

Gerasimos Filippatos

“Finerenone is an effective treatment option for CV and kidney protection for patients with mild to severe CKD and type 2 diabetes,” Gerasimos Filippatos, MD, FESC, FHFA, FACC, professor of cardiology at the National and Kapodistrian University of Athens in Greece, said during a press conference. “What is also extremely important is the results show that [urinary albumin-to-creatinine ratio] monitoring in patients with type 2 diabetes is important for the identification of patients who can benefit from treatment with finerenone independent of eGFR, as we see from the results in FIDELITY.”

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