Bayer Pharmaceuticals Pvt Ltd.

Introduction In FIDELITY, a prespecified pooled analysis of the phase III FIDELIO-DKD and FIGARO-DKD trials, finerenone reduced the risk of cardiovascular (CV) and kidney events versus placebo in patients with type 2 diabetes and chronic kidney disease, on optimized renin–angiotensin system blockade. This FIDELITY post hoc subanalysis explores the efficacy and safety of finerenone in Asian patients. Methods For this subanalysis, efficacy outcomes included a CV composite (time to CV death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for heart failure) and kidney composite (kidney failure, sustained ≥57% estimated glomerular filtration rate [eGFR] decrease from baseline over ≥4 weeks or renal death) outcome. Change in urine albumin-to-creatinine ratio (UACR) from baseline to month 4 and eGFR slopes were also assessed. All outcomes were assessed by baseline eGFR (<60 and ≥60 mL/min/1.73 m2) and UACR (<300 and ≥300 mg/g) subgroups. Safety outcomes were reported as treatment-emergent adverse events, including laboratory evaluations for hyperkalemia. Results In the Asian subpopulation, 1412/2858 (49.4%) received finerenone. Finerenone-treated Asian patients had a lower risk of the composite CV outcome (hazard ratio [HR]=0.90; 95% confidence interval [CI], 0.70–1.15), and nominally significant reductions in the risk of ≥57% and ≥40% eGFR composite kidney outcomes (HR=0.64; 95% CI, 0.50–0.82 and HR=0.67; 95% CI, 0.56–0.80, respectively) versus those receiving placebo, irrespective of baseline eGFR and UACR. Data on change of eGFR from baseline over the course of the trials indicated that chronic kidney disease progression in Asian patients was slower with finerenone versus placebo. Overall safety outcomes were balanced between both populations. Serum potassium values with finerenone were similar between the Asian and non-Asian subpopulations (>5.5 mmol/L: 15.6% versus 17.1%; >6.0 mmol/L: 4.6% versus 2.9%, respectively), while hyperkalemia leading to permanent treatment discontinuation with finerenone was low in both populations (Asian: 1.5%; non-Asian: 1.8%). Conclusion Finerenone reduced the risk of CV and kidney events and demonstrated a well-tolerated safety profile in the FIDELITY Asian subpopulation.