Credit: Original article published here.
There are limited treatment options to reduce persistent cardiovascular and renal risk in patients with type 2 diabetes and stage 4 chronic kidney disease (CKD). Results of FIDELITY, a prespecified pooled analysis of 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) demonstrated that heart-kidney outcomes were improved in participants with CKD and type 2 diabetes who were treated with finerenone.
Pantelis Sarafidis, MD, and colleagues conducted a FIDELITY subgroup analysis to examine the effects of finerenone among participants with stage 4 CKD (defined as estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2). Efficacy outcomes of interest were a cardiovascular composite (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) and a kidney composite (kidney failure, sustained ≥57% decrease in eGFR from baseline, or kidney disease death). Results were reported online in the Clinical Journal of the American Society of Nephrology [doi:10.2215/CJN.0000000000000149].
FIDELITY included 13,023 participants. Of those, 7% (n=890) had stage 4 CKD. The hazard ratio for risk of the cardiovascular composite outcome with finerenone versus placebo among participants with stage 4 CKD was 0.78 (95% CI, 0.57-1.07). The kidney composite outcome was not met for the overall study period; the protective effect with finerenone versus placebo was shown only up to 2 years. Following the 2-year mark, the direction of association was inconsistent and there was an observed loss of precision over time incurred on finerenone versus placebo risk differences. Albuminuria and rate of eGFR decline were consistently reduced with finerenone versus placebo.
The treatment arms were balanced in adverse events. The most common adverse event reported was hyperkalemia (stage 4 CKD: 26% and 13% for finerenone vs placebo, respectively). The incidence of hyperkalemia resulting in permanent discontinuation was low (stage 4 CKD: 3% and 2% for finerenone vs placebo, respectively).
In conclusion, the researchers said, “The cardiovascular benefits and safety profile of finerenone in participants with stage 4 CKD were consistent with the overall FIDELITY population; this was also the case for albuminuria and the rate of eGFR decline. The effects on the composite kidney outcome were not consistent over time.”
