The benefits of Finerenone extend to those with, without CVD

Among adults with chronic kidney disease and type 2 diabetes, the mineralocorticoid receptor antagonist finerenone reduced the incidence of CV events regardless of CVD status, according to new data from the FIDELIO study.

George L. Bakris

“We now have a drug, finerenone, which blocks mineralocorticoid receptor antagonist (MRA) activity that is well tolerated and safe compared to traditional MRAs such as spironolactone,” George L. Bakris, MD, professor of medicine and director of the American Heart Association-accredited Comprehensive Hypertension Center at the University of Chicago Medicine and senior author of the FIDELIO study, he told Healio. Finerenone not only slowed the progression of diabetic kidney disease but protected against the risk of cardiovascular events related to atherosclerosis and heart failure, given the absence of interaction with the prespecified endpoint. We now have another agent in our arsenal to preserve kidney and heart function. “

Gerasimos Filippatos

Adults with diabetes and chronic kidney disease (CKD) have a three times greater risk of death from CV than those with type 2 diabetes alone, Gerasimos Filippatos, MD, FESC, FHFA, FACC, professor of cardiology at the National and Kapodistrian University of Athens in Greece, he said during a press conference at the American Heart Association’s virtual science sessions. Hyperactivation of the mineralocorticoid receptor in these patients can lead to worsening of CVD and kidney disease, he said.

“Finerenone has shown potent anti-inflammatory and antifibrotic effects on the cardiovascular system in animal models,” Filippatos said.

New CV analysis

As previously reported by Healio, FIDELIO included 5,734 patients from 48 countries diagnosed with CKD and type 2 diabetes assigned to oral finerenone or placebo. The mean age of the patients in the study was 65.6 years; 70.2% were men. The estimated mean glomerular filtration rate (eGFR) was 44.3 mL / min / 1.73 m2² to the base. Almost 90% of the patients had severely elevated albuminuria; nearly half of the cohort (45.9%) had a history of CVD.

The primary outcome of the study was time to renal failure, a sustained reduction in eGFR of at least 40% from baseline, or renal death. The key secondary outcome was time to CV death, nonfatal MI, nonfatal stroke, or hospitalization for HF. Data presented to the American Society of Nephrology Kidney Week in October showed that finerenone was effective in reducing CV risk and slowing the progression of CKD in patients with diabetes.

During a median follow-up of 2.6 years, participants assigned to finerenone were 14% less likely to experience the composite CV outcome than placebo (HR = 0.86; 95% CI, 0.75- 0.99; P = .034). Researchers observed no significant interactions between patients with and without CVD, with an HR of 0.85 for those with a history of CVD (95% CI, 0.71-1.01) and an HR of 0.86 for those with no history of CVD (95% CI, 0.68-1.08; P = .85).

The new findings were published simultaneously in Circulation.

“Finerenone significantly reduced the overall CV event rate by 14% compared to placebo and we found that this effect was similar in patients with a history of CVD and in those without, demonstrating the benefit of finerenone for both primary and CV prevention. secondary in patients with CKD and type 2 diabetes, “Filippatos said.

Investigator-reported hyperkalaemia was higher among those assigned to finerenone than to placebo; however, permanent discontinuation of treatment related to hyperkalaemia was low compared to placebo, 2.3% vs 0.8% among participants with CVD and 2.2% vs 1% among those without CVD.

The safety profile of the drug was similar between those with and without CVD, Filippatos said.

“Learn to enroll” the most vulnerable

FIDELIO results demonstrate that investigators should “learn to enroll”, and not exclude, the most vulnerable patients, including those with impaired renal function and high CV risk, in large outcome clinical trials. Christoph Wanner, MD, from the department of medicine, division of nephrology of the university clinic in Würzburg, Germany, said during a discussion after the presentation.

“The new interventions for kidney patients – SGLT2 inhibitors and MRAs – are shifting the focus from glucose management to organ protection,” Wanner said. “Finerenone is both a cardiovascular and renal protective drug in people with type 2 diabetes and is an option where SGLT2 inhibitors are not preferred.”

Until the FIDELIO study, renin-angiotensin-aldosterone blockade therapy was limited due to the increased potassium levels often seen with such therapy, Wanner said. He noted that there was a “manageable” sign of hyperkalaemia observed with finerenone treatment, with 18 out of 100 patients showing some hyperkalemia during the study.

“We have entered a new era of effective treatments for diabetic kidney disease – that’s my feeling,” Wanner said. “Nothing has happened for 20 years. These new data shown today provide a good perspective for the FIGARO-DKD study in 2021 which will be published next year. “

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