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FIDELITY: Finerenone Slows CKD Progression Across Full Spectrum of Severity

Data from the FIDELITY analysis suggests use of finerenone was associated with a significant 20% reduction in end-stage kidney disease as well as reductions in all nonfatal kidney end points included in the study's composite kidney outcome.

New data presented at the American Society of Nephrology’s Kidney Week 2021 is providing insight into the effects of finerenone on kidney outcomes from the FIDELIO-DKD and FIGARO-DKD trials.

A prespecified meta-analysis of the trials, results indicate use of finerenone was associated with significant reductions in the incidence of all nonfatal components of the kidney composite outcome, including a 20% lower risk of end-stage kidney disease, among patients with type 2 diabetes and chronic kidney disease (CKD).

“The results of FIDELITY suggest that finerenone slows CKD progression across the spectrum of CKD severity in patients with type 2 diabetes,” said George Bakris, MD, professor of medicine at the University of Chicago, during his presentation at ASN Kidney Week 2021.

With the FIGARO-DKD and FIDELIO-DKD inclusion criteria designed with the aim of capturing the effects of finerenone across the full spectrum of CKD in patients with type 2 diabetes, FIDELITY was planned as a prespecified meta-analysis to provide a more complete overview of the effects finerenone in this patient population. Combining data from both trials, FIDELITY contained information from more than 13,000 patients with a median follow-up of 3 years.

With patients from both trials, inclusion criteria were diagnosis of type 2 diabetes and presence of CKD, which was defined as UACR of 30 to less than 300 mg/g and eGFR of 25-90 mL/min/1.73 m2 or UACR of 300 to less than 5000 mg/g and eGFR at or above 25 mL/min/1.73 m2. Patients were also required to be treated with optimized RAAS blockade.

The efficacy outcome of interest for FIDELITY included a composite kidney outcome of time to first onset of kidney failure, which was defined as end-stage kidney disease or a sustained eGFR less than 15 mL/min/1.73 m2, sustained 57% decrease or greater in eGFR from baseline over 4 weeks or more, or renal death.

Upon analysis, results indicated use of finerenone was associated with a 23% reduction in risk of the composite kidney outcome (HR, 0.77 [95% CI, 0.67-0.88]; P=.0002), with consistent benefits observed across subgroups defined by baseline eGFR (P for interaction=.62) and UACR (P for interaction=.67). Further analysis demonstrated use of finerenone was associated with a 20% reduction in end-stage kidney disease (HR, 0.80 [95% CI, 0.64-0.99]; P=.04), with significant reductions absorbed across all nonfatal components of the 57% eGFR decline composite end point.

Additionally, results suggested use of finerenone was associated with an initial drop in eGFR compared with placebo therapy (LS mean change in eGFR slope from baseline to month 4, –3.3 vs –1.0 mL/min/1.73 m2), but slowed long-term eGFR decline (LS mean change in eGFR slope from month 4 onwards, –2.5 vs –3.7 mL/min/1.73 m2/year).

Safety analysis indicated the incidence of adverse events was similar between those who were randomized to finerenone and those randomized to placebo therapy. The incidence of permanent discontinuation due to hyperkalemia in finerenone patients with an eGFR less than 60 mL/min/1.73 m2 was 2.4% compared to 0.8% with placebo therapy. Among those with an eGFR at or above 60 mL/min/1.73 m2, rate of discontinuation due to hyperkalemia was 0.6% among finerenone users and 0.3% among placebo recipients.

This study, “Finerenone and Kidney Outcomes in Patients with CKD and T2D: Results from FIDELITY,” was presented at ASN Kidney Week 2021.