Generalizability of kidney and cardiovascular protection by finerenone to the real world in Italy: insights from Fidelio and Figaro studies

Background: We evaluated the proportion of Type 2 diabetes (T2D) patients with chronic kidney disease (CKD) participating in the AMD (Association of Medical Diabetologists) Annals initiative who met the eligibility criteria for phase III-studies on finerenone, showing its renal and cardiovascular benefits. Methods: This analysis involved all T2D patients seen in 2019 in 282 diabetes centers in Italy, for whom data on kidney function (estimated glomerular filtration rate and albuminuria) were available. Data are presented separately for different scenarios, covering the population with main eligibility criteria for inclusion in the FIDELIO-DKD and FIGARO-DKD trials. Results: Among 343,037 T2D patients involved in the analysis, 5.4% met the eligibility criteria of the FIDELIO-DKD study (13.3% if we consider the population with fundus data) and 22.3% met those of the FIGARO-DKD trial. Overall, 110,000 (33%) patients were eligible for treatment with finerenone, with a male prevalence, an average age of 71 years, and good control of the main risk factors (HbA1c 7.3%; BP 138/76 mmHg; LDL-c 87 mg/dl), albeit with large percentages of not well controlled patients (50% with SBP > 140 mmHg; > 30% with LDL-c > 100 mg/dl). Over 12% were on sodium/glucose cotransporter 2 inhibitors or glucagon-like peptide 1 receptor agonists. Based on the event rate from the FIDELITY pooled analysis, the number of potentially avoidable events was 21.7 per 1000 eligible patients for the cardiovascular composite outcome and 16.7 for the renal outcome. Conclusions: This analysis showed that approximately 33% of patients with T2D present the main eligibility criteria for treatment with finerenone and could therefore benefit from it in the near future.