Physicians' Academy for Cardiovascular Education

CV and renal outcomes reduced by nonsteroidal MRA in T2DM across spectrum of kidney disease

News - Aug. 28, 2021

FIDELITY Analysis: finerenone in mild-to-severe chronic kidney disease and type 2 diabetes

Presented at the ESC congress 2021 by: Prof. Gerasimos Filippatos, MD - Athens, Greece

Introduction and methods

FIDELITY was a prespecified individual patient data pooled analysis of FIDELIO-DKD and FIGARO-DKD. Both trials investigated the effects of the nonsteroidal MRA finerenone on CV and renal outcomes in patients with diabetes and CKD treated with optimized RAS blockade and with a serum potassium of ≤4.8 mmol/L. Patients with symptomatic HFrEF were excluded. FIDELIO-DKD enrolled patients with predominantly advanced kidney disease, while FIGARO-DKD enrolled patients with mild-to-moderate kidney disease. Participants were randomized in a 1:1 ratio to receive either oral finerenone (10 or 20 mg) or placebo, once daily.

The FIDELITY analysis investigated the efficacy and safety of finerenone in patients with diabetes across the spectrum of kidney disease. A total of 13,026 patients were included in this analysis. The primary endpoint of the FIDELITY analysis was time to first occurrence of a composite of CV death, nonfatal MI, nonfatal stroke or HF hospitalization. The secondary endpoint was time to first occurrence of a composite of kidney failure, decrease in eGFR by ≥57% from baseline sustained for at least 4 weeks, or renal death. Median follow-up was 3.0 years.

Main results

Conclusion

This analysis showed that the nonsteroidal MRA finerenone reduced the risk of CV morbidity and mortality by 14% and reduced the risk of CKD progression by 23% in patients with T2DM and mild-to-severe CKD.

Prof. Filippatos also said: ‘UACR monitoring in patients with T2DM is important for the identification of patients who can benefit from treatment with finerenone, independent of eGFR.’

-Our reporting is based on the information provided at the ESC Congress-

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