Physicians' Academy for Cardiovascular Education

Beneficial effects of nonsteroidal MRA on mortality in patients with CKD and T2DM

Finerenone and effects on mortality in chronic kidney disease and type 2 diabetes: a FIDELITY analysis

Literature - Filippatos G, Anker SD, August P, et al. - Eur Heart J Cardiovasc Pharmacother. 2023 Feb 2;9(2):183-191. doi: 10.1093/ehjcvp/pvad001.

Introduction and methods

Background

Patients with CKD and T2DM have an increased all-cause mortality and CV mortality risk [1]. Finerenone, a selective nonsteroidal MRA, has cardiorenal benefits for patients with CKD and T2DM, as demonstrated by the complementary FIDELIO-DKD and FIGARO-DKD trials and their pooled FIDELITY (FInerenone in chronic kiDney diseasE and type 2 diabetes: Combined FIDELIO-DKD and FIGARO-DKD Trial programme analYsis) analysis [2-4].

Aim of the study

The authors investigated the causes of mortality in the FIDELITY dataset, and investigated whether finerenone protects patients with CKD and T2DM from mortality.

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Methods

This is a prespecified analysis of the FIDELIO-DKD and FIGARO-DKD trials, which were international, randomized, double-blind, placebo-controlled, multicenter trials. Key exclusion criteria were patients with HFrEF and non-diabetic kidney disease. In this analysis, a total of 13,026 patients with CKD and T2DM were included who were randomized to receive finerenone at a dose of 20 mg (10 mg if eGFR <60 mL/min/1.73 m2; 6519 patients) or placebo (6507 patients). Most patients (99.8%) were on RAS inhibitors as maximal tolerated dose of an ACEi or ARB for ≥4 weeks before screening was required.

Outcomes

Outcomes were all-cause mortality, CV mortality, renal mortality, and non-CV, non-renal mortality.

Main results

Intention-to-treat population

On-treatment population

Causes of mortality

Subpopulation

Conclusion

Using the FIDELITY dataset, the authors demonstrated that finerenone reduced all-cause mortality and CV mortality in patients with CKD and T2DM. Moreover, finerenone lowered the incidence of sudden cardiac death compared to placebo. The benefits of finerenone on survival was greater in patients with higher baseline eGFR, indicating that early treatment is warranted to maximize the protective effects of finerenone in this patient population.

References

Show references

Find this article online at Eur Heart J Cardiovasc Pharmacother.

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