New Kerendia data show impact of early albuminuria reduction in patients with chronic kidney disease, type 2 diabetes: Bayer
Berlin: Bayer has announced new late-breaking Kerendia (finerenone) data from FIDELITY, a prespecified pooled analysis of the Phase III FIDELIO-DKD and FIGARO-DKD trials, confirming that early albuminuria reduction in patients with chronic kidney disease (CKD) in type 2 diabetes (T2D) mediated a large proportion of the treatment effect against CKD progression. Findings also demonstrate a notable, albeit modest, correlation between early albuminuria reduction and improved cardiovascular (CV) outcomes. The analyses, based on pooled data from more than 12,500 patients, were presented at the American Society of Nephrology’s (ASN) Kidney Week 2023.
“The latest analyses from FIDELITY are of great reassurance to the clinical community, confirming the impact of early UACR reduction with finerenone treatment on long-term outcomes of patients with chronic kidney disease and type 2 diabetes,” said Rajiv Agarwal, MD, Professor of Medicine, Indiana University School of Medicine and VA Medical Centre, Indianapolis, USA and Co-Chair of the FIDELIO-DKD and FIGARO-DKD Steering Committee. “Chronic kidney disease is a progressive condition, significantly impacting patients’ lives as the disease advances. Reducing the urine albumin-to-creatinine ratio as early as possible to reduce the risk of kidney and cardiovascular outcomes is vital.”
The post hoc mediation analysis used data from the pooled analysis FIDELITY to quantify finerenone-induced kidney and CV risk reductions over a 4-year period, compared to placebo, mediated by change in urine albumin-to-creatinine ratio after 4 months of treatment. To measure the mediated effect of UACR reduction, causal mediation analyses were conducted, separating composite kidney (kidney failure, sustained ≥57% decrease in estimated glomerular filtration rate from baseline, or kidney death) and CV outcomes (CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure).
The analysis showed that UACR reduction, analyzed as a continuous variable, mediated 83% and 36% of the treatment effect of finerenone on the kidney and CV outcomes, respectively.
“It is good news to see that early UACR reduction with finerenone translates especially into a reduction of kidney complications,” said Dr. Christian Rommel, Member of the Executive Committee of Bayer AG's Pharmaceutical Division and Head of Research and Development. “At Bayer, our commitment to improve the long-term outcomes of patients in need of innovative treatments is unwavering. The new findings help underscore the important role finerenone can play in improving the lives of people living with chronic kidney disease associated with type 2 diabetes.”
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