Reviewer: Dr Mehmet Arslan

Name of the Study: Finerenone and Effects on Mortality in Chronic Kidney Disease and Type 2 Diabetes: A FIDELITY Analysis

FIDELITY: Finerenone in Pts With Chronic Kidney Disease

Published Congress: ESC 2022

Link : https://www.escardio.org/The-ESC/Press-Office/Press-releases/Finerenone-benefits-patients-with-diabetes-across-spectrum-of-kidney-disease

Giriş: Patients with type 2 diabetes and chronic kidney disease have shorter life expectancy than their peers without these conditions. Most deaths in these patients are due to cardiovascular disease. With the prevalence of chronic kidney disease and type 2 diabetes rising, more efforts are needed to improve survival in this patient population.

Amaç: The current analysis evaluated the causes of mortality in the FIDELITY population.

Metod: This was a prespecified, exploratory analysis of individual patient data pooled from FIDELIO-DKD and FIGARO-DKD. The analysis included 13,026 patients with type 2 diabetes and chronic kidney disease randomised to treatment with finerenone or placebo. All patients were optimally treated with a renin-angiotensin system inhibitor. The median duration of follow up was 3.0 years.

Bulgular: Mortality was most commonly attributed to cardiovascular causes (4.9% in the finerenone group vs. 5.6% in the placebo group) In intention-to-treat analyses, finerenone was not associated with reduced risk for all-cause death, with an HR of 0.89 that did not reach statistical significance (95% CI, 0,7-1; P = .051), or CV death, with an HR of 0.88 (95% CI, 0.76-1.02; P = .092). However, researchers did see a benefit for sudden cardiac death among participants assigned finerenone, with an HR of 0.75 that reached statistical significance (95% CI, 0.57-0.996; P = .046) compared with placebo. In the on-treatment analyses, which included events that occurred while patients were receiving treatment and for up to 30 days after the last dose of study medication, finerenone was associated with reduced risk for all-cause death (HR = 0.82; 95% CI, 0.7-0.96; P = .014), as well as CV death (HR = 0.82; 95% CI, 0.67-0.99; P = .04).

Sonuç: In this analysis, mortality was primarily attributed to cardiovascular events. Finerenone does not reduce the risk of all-cause death in patients with type 2 diabetes and kidney disease but does lower the likelihood of sudden cardiac death. The effect of finerenone on all-cause mortality, cardiovascular mortality and sudden cardiac death was consistent irrespective of estimated glomerular filtration rate (eGFR) or urine albumin-to-creatinine ratio (UACR) at baseline, but seemingly more pronounced in patients with a higher baseline eGFR.

Interpretations: Finerenone does not reduce the risk of all-cause death in patients with type 2 diabetes and kidney disease but does lower the likelihood of sudden cardiac death. It should be noted that 'on-treatment' analyzes impair randomization and the study sample consisted of patients without a history of arrhythmia and with preserved cardiac function.