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April 12, 2022

Reduced risk of CV morbidity and mortality demonstrated in FIDELITY study

Data from the FIDELITY study will support the use of finerenone to improve cardiorenal outcomes for CKD and T2D patients.

By GlobalData Healthcare

At this year’s American College of Cardiology (ACC) Scientific Session, positive results were presented from Bayer’s FIDELITY analyses of Kerendia (finerenone), providing insight into the drug’s ability to reduce the risk of cardiovascular and kidney outcomes in diabetic kidney disease patients. In particular, the trial set out to evaluate whether finerenone is effective and safe in treating patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). The positive data from the FIDELITY study will help support the use of finerenone to improve cardiorenal outcomes for CKD and T2D patients.

The FIDELITY study, which involved 13,000 patients, showed that cardiovascular benefit was mainly driven by a 14% decrease in risk of cardiovascular morbidity and 23% decrease in CKD progression. In addition, the study found that finerenone sustained a 57% decrease in estimated glomerular filtration rate from baseline over a four-week period. Regarding overall safety, hyperkalaemia (HK) risk was increased in patients receiving finerenone, at 1.7%, compared with 0.6% in placebo patients. Key opinion leaders interviewed by GlobalData have emphasised that physicians are reluctant to prescribe mineralocorticoid receptor antagonists (MRAs), as HK is a common adverse event.

Bayer previously completed a Phase III study, FIDELIO-DKD. The study showed that finerenone was able to delay the progression of CKD through reducing the combined risk of time to first incidence of kidney failure, and a sustained decrease of estimated glomerular filtration rate above 40% from baseline over a four-week period. The FIGARO-DKD trial also showed that end-stage kidney disease occurred in 32 patients in the finerenone group compared with 49 patients in the placebo group.

The large number of patients in the FIDELITY analyses will likely drive a better understanding of the effects of finerenone on CKD and T2D. According to GlobalData’s Pharma Intelligence Centre drug database, Bayer has two products in development for diabetic nephropathy: finerenone and fulacimstat. Finerenone is an MRA that acts as a diuretic and lowers blood pressure by inhibiting the reabsorption of salts, decreasing blood volume and antagonising the action of aldosterone, which is a component of the renin-angiotensin-aldosterone system.

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