Finerenone, a selective mineralocorticoid receptor antagonist, significantly reduces the incidence of sudden cardiac death in patients with early-stage and end-stage chronic kidney disease (CKD) and type 2 diabetes mellitus, as reported at the Congress of the European Society of Cardiology (ESC).
The FIDELITY dataa prespecified pooled analysis of the phase III FIDELIO-DKD and FIGARO-DKD studies, highlight the potential of finerenone to reduce the incidence of sudden cardiac death. The positive effect of finerenone on all mortality outcomes was consistent across a wide variety of patients with chronic kidney disease in early or terminal stage and type 2 diabetes, regardless of baseline estimated glomerular filtration rate (eGFR) or urinary albumin/creatinine ratio (UCAC), and appeared to be more pronounced in patients with higher baseline eGFR. Cardiovascular (CV) mortality was the most frequent cause of mortality in the study.
Finerenone shows positive effects on mortality in patients with chronic kidney disease and type 2 diabetes
As he points out Dr Gerasimos Filippatosprofessor of cardiology at the National and Kapodistrian University of Athens (Greece) and co-principal investigator of the phase III FIDELIO-DKD and FIGARO-DKD clinical trials, “the Chronic kidney disease is an often underappreciated and life-threatening condition.. Chronic kidney disease can shorten the life expectancy of patients with diabetes by up to 16 years, compared to the general population without either disease.”.
In this regard, this specialist highlights that “Building on the growing body of clinical data for finerenone, which have demonstrated benefit of this treatment on renal and cardiovascular outcomes, these new data highlight the positive effects of finerenone on mortality in a wide variety of disease severity in patients with chronic kidney disease and type 2 diabetes».
The mean age of the FIDELITY population was 64.8 years and 69.8% of the patients were male. At baseline, patients had a mean eGFR of 57.6 mL/min/1.73 m and the median CACO was 515 mg/g. Most of the patients received drugs with CV effects (99.8% with renin-angiotensin system inhibitors (ISRAs), 72.2% with statins and 49.9% with beta-blockers).
In the general population, the incidence of all-cause mortality was 8.5% with finerenone vs 9.4% with placebo (HR 0.89; p = 0.051). Mortality from CV causes was considered the most common cause of death (4.9% with finerenone vs 5.6% with placebo), followed by mortality from infection (1.5% with finerenone vs 1.4% placebo) and malignancy (1.2% finerenone vs. 1.6% placebo).
It was observed that finerenone significantly reduces sudden cardiac death compared to placebo (HR 0.75 p = 0.046). Prespecified on-treatment analyzes revealed significant reductions in the incidence of all-cause mortality with finerenone versus placebo (HR 0.82; p = 0.014) and in the incidence of CV mortality with finerenone versus placebo ( HR 0.82, p = 0.040).
Reduce the risk of mortality in patients with chronic kidney disease and type 2 diabetes
The Dr. Christian Rommelmember of the Executive Committee of the Pharmaceutical Division of Bayer AG and responsible for Research and Development, warns that “Despite optimized glycemic and blood pressure control, many patients with chronic kidney disease and type 2 diabetes continue to progress to renal failure and have a significantly increased risk of death from cardiovascular causes»highlighting that “The exploratory analysis presented shows the potential of finerenone to reduce the risk of mortality in this vulnerable patient population and keep them healthier for longer”.
In February 2022, start CONFIDENCE studya phase II study with three treatment arms that will investigate concomitant initial combination therapy with finerenone and the SGLT2 inhibitor empagliflozincompared with finerenone monotherapy and empagliflozin monotherapy, respectively, in patients with chronic kidney disease and type 2 diabetes.
The primary objective of the study is to demonstrate that the simultaneous initiation and combined use of finerenone and empagliflozin is superior to empagliflozin monotherapy or finerenone monotherapy in reducing the urinary albumin/creatinine ratio.