In a recent study conducted by Sankar D Navaneethan and colleagues and published in the International Society of Nephrology, the cardiovascular and kidney benefits of Bayer’s Kerendia (finerenone) are maintained regardless of acute changes in estimated glomerular filtration rate (eGFR) following treatment initiation in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). Leading data and analytics company GlobalData believes that this comprehensive analysis will reassure nephrologists about prescribing finerenone to patients with CKD and T2D, even if initial eGFR declines are observed. The consistent efficacy across eGFR change subgroups, combined with a manageable safety profile, supports the use of finerenone as an important therapeutic option for this high-risk patient population.
Finerenone is a nonsteroidal mineralocorticoid receptor antagonist (MRA). Compared to steroidal MRAs, finerenone has a shorter half-life and a more balanced distribution between the heart and the kidney. The study included an analysis of the prespecified FIDELITY trial, a pooled individual-level analysis of two major Phase III clinical trials: FIDELIO-DKD and FIGARO-DKD. This new analysis addressed an important clinical concern, specifically the hesitancy to prescribe or continue medications associated with acute eGFR decline. The study demonstrated that finerenone consistently reduced composite cardiovascular outcomes across all eGFR change subgroups, with hazard ratios of 0.74 (95% confidence interval 0.61-0.90) for patients with more than 10% eGFR decline, 0.87 (0.73-1.04) for >0-10% eGFR decline, 1.06 (0.87-1.28) for 0-10% eGFR increase, and 0.78 (0.61-0.99) for more than 10% eGFR increase. While there was a numeric interaction (p=0.048), the interaction was not significant (p=0.58) when modelled as a continuous variable. Similarly, finerenone reduced composite kidney outcomes across all eGFR change categories, with hazard ratios of 0.67 (0.53-0.85) for more than 10% eGFR decline, 0.78 (0.61-1.01) for >0-10% eGFR decline, 0.56 (0.40-0.77) for 0-10% eGFR increase, and 0.75 (0.50-1.14) for more than 10% eGFR increase. The interaction was not significant (p=0.23 for categories, p=0.36 for continuous modelling). These findings provide reassurance for nephrologists who may be hesitant to prescribe medications associated with initial eGFR reductions.
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Kerendia received US Food and Drug Administration approval in July 2021 to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalisation for heart failure in adults with CKD associated with T2D.
