Achieving guideline-based treatment goals remains central to reducing cardiovascular and kidney risk in patients with chronic kidney disease (CKD) and type 2 diabetes mellitus (T2DM). An exploratory analysis published in Diabetes, Obesity and Metabolism evaluated whether baseline attainment of recommended care targets influenced the treatment effects of finerenone.
The analysis used FIDELITY, a prespecified pooled dataset of the randomized, double-blind, multicenter phase III FIDELIO-DKD and FIGARO-DKD trials. Participants with T2DM and CKD were randomized 1:1 to finerenone or placebo. Subgroups were defined by the number of baseline treatment goals achieved: glycated hemoglobin (HbA1c) 7.0% or lower, blood pressure below 130/80 mmHg, low-density lipoprotein cholesterol below 1.81 mmol/L, and use of a sodium-glucose cotransporter-2 inhibitor or glucagon-like peptide-1 receptor agonist. Cardiovascular and kidney outcomes, hospitalization for heart failure (HF), cardiovascular death, and adverse events were assessed.
At study entry, 29% met no treatment goals, 40% met 1 goal, 24% met 2 goals, and 7% met at least 3 goals. In placebo-treated participants, higher goal attainment was associated with fewer composite cardiovascular events, with rates per 100 patient-years of 6.0, 5.1, 4.3, and 3.5 across increasing goal categories. Similar patterns were reported for other outcomes.
No heterogeneity was observed in finerenone treatment effects across subgroups. The safety profile of finerenone versus placebo was consistent regardless of baseline goal attainment. These findings suggest finerenone may provide cardiorenal benefit across a broad range of baseline risk management profiles.