Bayer releases new subgroup analyses for Kerendia for CKD

Germany’s Bayer (BAYN: DE) has announced late-breaking data from prespecified exploratory subgroup analyses of FIDELITY, a prespecified pooled analysis of the Phase III FIDELIO-DKD and FIGARO-DKD trials.

These analyses investigated Kerendia (finerenone) versus placebo on composite cardiovascular (CV) and kidney outcomes in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D), with and without a history of atherosclerotic cardiovascular disease (ASCVD). The subgroup analyses were presented today at the American College of Cardiology’s 71st Annual Scientific Session (ACC.22).

Out of the 13,026 patients included in the FIDELITY full analysis, 5,935 (45.6%) had a history of ASCVD at baseline. Over a median follow-up of three years, patients with ASCVD versus those without had the following composite CV outcome of time to CV death, nonfatal myocardial infarction (MI), nonfatal stroke and hospitalization for heart failure (HHF; incident rate [IR]/100 patient-years [PY] 6.9 vs 3.0; hazard ratio [HR] 2.09; 95% confidence interval [CI] 1.89–2.30), composite outcome of time to CV death or HHF (IR/100 PY, 4.51 vs 1.92; HR: 2.12; 95% CI 1.88–2.40) and composite kidney outcome (IR/100 PY 2.1 vs 2.4; HR: 0.96; 95% CI 0.83–1.10).1