Finerenone points to the second success of the fundamental test in DKD

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Finerenone, a research agent for a new class of drugs, has just won a second victory in a key trial after showing a significant benefit in slowing the progression of diabetic kidney disease in patients with type 2 diabetes in the fundamental FIDELIO-DKD trial with more than 5700 patients.

Early FIGARO-DKD results showed significant benefits for the primary endpoint of cardiovascular mortality and non-fatal cardiovascular disease purpose in a placebo-controlled trial with approximately 7,400 patients with type 2 diabetes, according to Bayer, the company that develops finerenone, a statement released May 10th.

Based on the FIDELIO-DKD results, finerenone is currently under review by the U.S. Food and Drug Administration for marketing approval as a treatment for patients with type 2 diabetes and chronic kidney disease. FIDELIO-DKD, in addition to the primary primary endpoint that focused on slowing the progression of diabetic kidney disease, had a secondary endpoint that assessed the combined incidence in the treatment of cardiovascular death or non-fatal episodes of stroke, MI or hospitalization for heart attack. Study results published in 2020 at New England Journal of Medicine demonstrated that finerenone was safe and effective for both endpoints.

In the current study, FIGARO-DKD, executed at more than 1,000 sites in 47 countries, these endpoints turned upside down. The primary outcome was a compound of cardiovascular deaths or nonfatal cardiovascular disease, and the secondary outcome was prevention of DKD progression.

Aside from claiming that the results significantly met FIGARO-DKD’s primary criterion of reducing the incidence of combined cardiovascular disease criteria, the release did not provide further details on the results. The statement noted that the cohort of patients enrolled in FIGARO-DKD included more patients with early-stage chronic kidney disease, compared with FIDELIO-DKD.

Finerenone is a first-class nonsteroidal mineralocorticoid receptor (MRA) selective antagonist. As an ARM, he shares certain activities with steroid ARMs spironolactone i eplerenone. But the absence of a steroid structure means that finerenone does not cause steroid-like side effects gynecomastia. FIDELIO-DKD results showed that finerenone caused more hyperkalemia than placebo, but the level of hyperkalaemia it causes with respect to spironolactone or eplerenone remains uncertain.

This article originally appeared on MDedge.com, which is part of the Medscape professional network.





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