Therapy Areas: Cardiovascular
Kerendia Reduces the Risk of Cardiovascular Outcomes in New Phase III FIGARO-DKD Study in Adults with Chronic Kidney Disease Associated with Type 2 Diabetes
30 August 2021 - - Detailed results from the Phase III FIGARO-DKD study demonstrated that compared with placebo, Kerendia (finerenone) a first-in-class nonsteroidal mineralocorticoid receptor antagonist significantly reduced the risk of the composite primary endpoint of time to first occurrence of cardiovascular death or nonfatal CV events (myocardial infarction, stroke or heart failure hospitalization) by 13% (relative risk reduction, HR 0.87 [95% CI, 0.76-0.98; P=0.0264]) over a median duration of follow-up of 3.4 years when added to maximum tolerated labeled dose of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker in adults with chronic kidney disease associated with type 2 diabetes, German pharmaceutical and life sciences company Bayer (OTC: BAYRY) said.

The reduction in the CV composite outcome was primarily driven by hospitalization due to heart failure. These data were presented TODAY during a Hot Line session at the ESC Congress 2021 and simultaneously published in the New England Journal of Medicine.

FIGARO-DKD is the first contemporary Phase III cardiorenal trial with the majority of patients with stages 1-2 CKD (estimated glomerular filtration rate [eGFR] ≥60 ml/min/1.73m2) to show CV benefit in CKD associated with T2D.

Patients were included in this study if they had urine albumin-to-creatinine ratio levels 30–5000 mg/g.1 Kerendia was approved in the United States on July 9, 2021 to reduce the risk of sustained eGFR decline, end-stage kidney disease, CV death, nonfatal myocardial infarction and hospitalization for heart failure in adult patients with CKD associated with T2D.

FIGARO-DKD (FInerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease), a randomized, double-blind, placebo-controlled trial, randomly assigned 7,437 participants from 48 countries to finerenone 10 mg or 20 mg orally once daily or placebo when added to standard of care, including blood glucose-lowering therapies and a maximum tolerated labeled dose of ACEis or ARBs.

Patients had UACR ≥30–