Physicians' Academy for Cardiovascular Education

Obesity does not influence beneficial effects of nonsteroidal MRA in CKD and T2D

The impact of obesity on cardiovascular and kidney outcomes in patients with chronic kidney disease and type 2 diabetes treated with finerenone: Post hoc analysis of the FIDELITY study

Literature - Rossing P, Anker SD, Filippatos G, et al. - Diabetes Obes Metab. 2023 Jul 4 [Online ahead of print]. doi: 10.1111/dom.15197

Introduction and methods


Patients with obesity have an increased risk of developing CKD, CVD, T2D, and hypertension compared with people with a health body weight [1,2]. The FIDELITY (FInerenone in chronic kiDney diseasE and type 2 diabetes: Combined FIDELIO-DKD and FIGARO-DKD Trial programme analYsis) prespecified pooled analysis previously showed the selective, nonsteroidal MRA finerenone reduced the risks of CV outcomes and kidney disease progression in patients with CKD and T2D compared with placebo [3]. However, data on the influence of obesity on the response to MRAs in this patient population are limited.

Aim of the study

In a post-hoc analysis of the FIDELITY dataset, the authors assessed whether the CV and renal benefits of finerenone in the overall FIDELITY population were consistent in patients with CKD and T2D with and without obesity.


The FIDELITY dataset is a prespecified, individual patient-level data pooled analysis of the FIDELIO-DKD (Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease) and FIGARO-DKD (Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease) trials [3-5]. In these multicenter, double-blind, placebo-controlled, phase 3 RCTs, a total of 13,026 patients with T2D and CKD were randomized to oral finerenone (10 or 20 mg once daily based on eGFR at the screening visit) or placebo. Median follow-up duration was 3.0 years (IQR: 2.3–3.8).

In this post-hoc analysis, 12.986 participants were stratified into 2 groups by their waist circumference (WC)—which represents the degree of visceral obesity—: low-risk (n=1198; 9.2%) or high-risk to very high–risk (n=11.788; 90.8%).


Efficacy endpoints included, among others: (1) composite CV outcome, consisting of time to first event of CV death, nonfatal MI, nonfatal stroke, or hospitalization for HF; (2) composite renal outcome, consisting of time to first event of kidney failure, sustained eGFR decline ≥57% from baseline, or kidney disease death; and (3) results from an additional analysis of covariance on annualized eGFR slopes.

Safety outcomes included the incidence of investigator-reported adverse events and other safety events such as a change in systolic blood pressure.

Main results

CV outcome

Renal outcome



This post-hoc analysis of the FIDELITY dataset showed that visceral obesity did not significantly modify the effects of finerenone versus placebo on reducing the risk of CV events and kidney disease progression in patients with CKD and T2D. Although finerenone appeared to have greater cardiorenal benefits in the high-/very high–risk WC group, there was no significant heterogeneity between the 2 WC groups, which the authors believe may be due to the small sample size of the low-risk WC group. The safety profile of finerenone was similar in both WC groups, and the drug was generally well tolerated.


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Find this article online at Diabetes Obes Metab.

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