Top-line results from a study evaluating the investigational drug finerenone (BAY94-8862, Bayer) in patients with chronic kidney disease (CKD) and type 2 diabetes show the agent met its primary endpoint, delay in disease progression, relative to placebo.
The Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease (FIDELIO-DKD) study is part of the largest phase 3 clinical program in CKD and type 2 diabetes to date, Bayer said.
The results show finerenone significantly reduced the combined risk of time to first occurrence of kidney failure, a sustained decrease in estimated glomerular filtration rate (eGFR) ≥ 40% from baseline over ≥ 4 weeks, or renal death, compared with standard of care plus placebo, according to a company press release.
Finerenone also significantly reduced the risk of the key secondary outcome, a composite of time to first occurrence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or heart failure hospitalization, the company notes.
The full study findings will be presented at an upcoming scientific meeting.
The trial included approximately 5700 patients with both early and more advanced stages of kidney disease and type 2 diabetes. Patients received finerenone 10 mg or 20 mg once a day, or placebo. Standard of care included blood glucose-lowering therapies and maximum tolerated doses of either an angiotensin-converting enzyme inhibitor or an angiotensin II receptor blocker.
Bayer said it will discuss the data with health authorities regarding the submission of marketing authorization applications for finerenone.
Other Studies of Finerenone: FIGARO-DKD and FINEART-HF
A second study, the Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD), is ongoing.
The goal of the FIGARO-DKD study is to investigate the safety and efficacy of finerenone versus placebo plus standard of care in terms of cardiovascular morbidity and mortality.
FIGARO-DKD involves approximately 7400 patients with CKD and type 2 diabetes.
As the press release details, finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist (MRA) shown to inhibit the deleterious effects of mineralocorticoid receptor overactivation.
Mineralocorticoid receptor overactivation is thought to be a major driver of both renal and cardiac damage.
Bayer also recently initiated a third study, the FINEARTS-HF study, the goal of which is to investigate finerenone compared with placebo in over 5500 symptomatic heart failure patients with a left ventricular ejection fraction ≥ 40%. The primary endpoint is the effect of finerenone, compared with placebo, in reducing the composite endpoint of cardiovascular death and first and recurrent heart failure.
Aldosteronism: A Driver of Hypertension?
In a recent study, researchers found that 16% to 22% of patients with hypertension appear to have primary aldosteronism as the most likely cause, a much higher prevalence than previously thought.
The finding could potentially change how some patients with hypertension are screened and managed; the best approach to diagnose primary aldosteronism is to measure the aldosterone–renin ratio.
Identifying patients with hypertension and primary aldosteronism, as well as patients with hypertension and excess aldosterone production, is important because the best treatment may turn out to be unilateral adrenal gland removal or one of the MRA drugs already on the market, such as spironolactone (Aldactone, Pfizer) or eplerenone (Inspra, Pfizer).
However, both MRAs can cause hyperkalemia, which potassium-binding agents only partially blunt.
It has been suggested that finerenone may cause less hyperkalemia than these other aldosterone-blocking agents.
The FIDELIO-DKD study was funded by Bayer.
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Cite this: Top-Line Results: Finerenone Delays Progression in CKD With Diabetes - Medscape - Jul 14, 2020.