Study Design and Baseline Characteristics of Pooled Analysis on Finerenone's Effect on Cardio-Kidney Outcomes in CKD & Type 2 Diabetes/Heart Failure at Heart Failure 2024

The FINE-HEART study, a new predetermined exploratory pooled analysis of three Phase III trials involving finerenone, was recently introduced at Heart Failure 2024, a scientific congress organized by the European Society of Cardiology in Lisbon. Finerenone, marketed as Kerendia®, is globally approved for treating adults with chronic kidney disease (CKD) related to type 2 diabetes (T2D) in over 70 countries, including the United States.

FINE-HEART aims to evaluate the effects of finerenone on cardio-kidney outcomes from data on more than 19,000 patients with various combinations of heart failure (HF), CKD, and T2D across three Phase III finerenone studies: FIDELIO-DKD, FIGARO-DKD, and FINEARTS-HF. Over 92% of the patients included had overlapping cardio-kidney-metabolic (CKM) conditions, with 78% presenting two conditions (HF and CKD, HF and T2D, or CKD and T2D), and 14.7% having all three. Additionally, 37% had a history of HF, 81% had a history of T2D, and 89% had a history of CKD.

The analysis revealed that patients were at a high risk of CKD progression, either due to reduced estimated glomerular filtration rate (eGFR) or albuminuria. Specifically, 30% had an eGFR of less than 45, and 26% had an eGFR ranging from 45 to 60 mL/min/1.73m2. Moreover, 31% had an "A2" urine albumin-to-creatinine ratio (UACR) of 30-300 mg/g, and 49% had an "A3" UACR greater than 300 mg/g.

Dr. Robert Perkins, Vice President of U.S. Medical Affairs/Cardiovascular-Renal at Bayer, emphasized the importance of the FINE-HEART study for understanding the impact of finerenone on cardio-kidney outcomes. He noted that the analysis encompasses over 19,000 patients, making it one of the most comprehensive studies of individuals with increasingly common and complex conditions.

The FINE-HEART analysis includes data from the FIDELITY program, which comprises the FIDELIO-DKD and FIGARO-DKD trials. These trials involved more than 13,000 patients with CKD associated with T2D and albuminuria, who were on maximally tolerated doses of renin-angiotensin system inhibitors across 48 countries. It also incorporates data from the FINEARTS-HF trial, which included over 6,000 patients with HF with left ventricular ejection fraction (LVEF) of 40% or more, elevated natriuretic peptides, and evidence of structural heart disease across 37 countries.

Kerendia is a non-steroidal mineralocorticoid receptor antagonist (MRA) that was approved by the U.S. FDA in July 2021. It is intended to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with CKD associated with T2D.

Kerendia has been recommended for adults with CKD associated with T2D in several major treatment guidelines, including those from the American Diabetes Association, the American Association of Clinical Endocrinology, and the Kidney Disease: Improving Global Outcomes Foundation.

Patients with CKD associated with T2D are at a threefold higher risk of dying from cardiovascular-related causes than those with T2D alone. CKD is a serious, progressive condition frequently arising from T2D and is an independent risk factor for cardiovascular disease. Approximately 40% of all patients with T2D develop CKD. Despite available therapies, patients with CKD associated with T2D remain at high risk of CKD progression and cardiovascular events. T2D is the leading cause of end-stage kidney disease, necessitating dialysis or kidney transplantation for survival.

Heart failure is a prevalent chronic condition affecting about 6.5 million adults in the U.S., characterized by the heart's inability to pump sufficient blood to meet the body's needs. Patients with diabetes have more than twice the risk of developing heart failure compared to their healthier counterparts, and they face worse cardiovascular outcomes, hospitalization rates, and prognosis than those without diabetes.