New data support renal and cardiovascular benefits of Kerendia in patients with and without history of left ventricular hypertrophy and chronic kidney disease and type 2 diabetes.
Late-breaking data from an exploratory post hoc analysis from FIDELITY, a prespecified pooled analysis of the Phase III FIDELIO-DKD and FIGARO-DKD trials, reinforce the renal and cardiovascular (CV) benefits of Kerendia (finerenone), a non-steroidal, selective mineralocorticoid receptor (MR) antagonist.
Data from the analysis indicate that compared to placebo, Kerendia consistently reduced the risk of the composite CV and kidney outcomes in addition to standard of care across a broad spectrum of CKD associated with T2D, with or without electrocardiography-determined left ventricular hypertrophy (LVH) at baseline.
LVH is a predictor of cardiovascular (CV) disease and associated morbidity and mortality. Of the 13,026 patients with CKD and T2D analyzed, 1250 had LVH at baseline. The demographic and baseline characteristics between those with or without LVH were well balanced but a higher urine albumin-to-creatinine ratio was observed in patients with LVH versus those without. A higher proportion of patients with LVH at baseline had a history of CV disease, including coronary artery disease, heart failure, MI, and stroke. Concomitant treatment with beta-blockers and platelet aggregation inhibitors was more frequent in those with LVH.
Finerenone consistently reduced the relative risk of the CV composite outcome in patients with and without LVH (reduction of 28% vs 11%, respectively; p-value for interaction 0.11). The relative risk reduction of the kidney composite outcome was also consistent between patient subgroups (44% reduction in patients with LVH vs 20% without LVH; p-value for interaction 0.18). The relative risk of the CV endpoint component heart failure hospitalization (HHF) was reduced in both patient subgroups (66% reduction in patients with LVH vs 14% without LVH), with the effect of finerenone being significantly greater in patients with LVH (p-value for interaction 0.0024). Overall, safety was similar between subgroups; most adverse events were mild to moderate in severity. The incidence of hyperkalaemia was higher with finerenone vs placebo irrespective of baseline LVH status, however discontinuation due to hyperkalaemia remained low in both groups.
“Patients with chronic kidney disease and type 2 diabetes are often characterized by a complex risk profile,” said Dr. Christian Rommel, Member of the Executive Committee of Bayer AG's Pharmaceutical Division and Head of Research and Development. “The exploratory analysis presented highlights the cardiovascular and kidney benefits of finerenone in a particularly vulnerable subgroup of patients with chronic kidney disease and type 2 diabetes, underlining the potential of this treatment to keep patients out of hospital and to protect their heart and kidneys.
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