The European Medicines Agency (EMA) has authorized the use of the mineralocorticoid drug Kerendia (finerenone) for the treatment of heart failure. Initially, the drug was approved for the treatment of chronic kidney disease in patients with type 2 diabetes. According to the new regulation, the medication is intended for patients whose hearts retain at least partial blood-pumping ability (ejection fraction of 40% or more). This decision is based on a large-scale clinical study (FINEARTS-HF Phase III trial), which confirmed that finerenone reduces the risk of complications and mortality by 16%.
The active substance of the drug, finerenone, acts on mineralocorticoid receptors in the body. Excessive activity of these receptors leads to inflammation and scarring (fibrosis) of heart tissue. Kerendia binds firmly to them and effectively stops these pathological processes. Patients take the medication once a day in tablet form.
Unlike older generation drugs (e.g., spironolactone), finerenone has a non-steroidal structure, which makes it more selective and safer. It works successfully in combination with SGLT2 inhibitors and does not interfere with the therapeutic action of other basic medications. This property of the drug allows patients to effectively continue treatment without additional complications.
Results of the FINEARTS-HF Study
The international clinical trial was conducted in 654 medical centers across 37 countries. It involved 6,001 patients over the age of 40 with an ejection fraction of 40% or more. The majority of participants (69%) presented with New York Heart Association Class II (NYHA II) heart failure. Patients received either finerenone or a placebo in combination with standard therapy (average observation period – 32 months).
The study showed a significant decrease in the rate of complications in the finerenone group. Specifically, cases of worsening heart failure were 18% lower. Regarding mortality, the difference according to this indicator was minor: cardiovascular-related lethality was 8.1% in the finerenone group and 8.7% in the placebo group.
Participants in the study confirmed the alleviation of symptoms through the Kansas City Cardiomyopathy Questionnaire (KCCQ). Finerenone effectively improved the patients’ condition compared to the placebo. Additionally, the need to increase the dose of diuretics in outpatient conditions decreased by 11%, indicating the stability of the heart’s condition. Regarding the overall mortality rate, it amounted to 16.4% in the finerenone group, which was lower than the data of the placebo group (17.4%).
Safety Profile
During treatment with the drug, special attention is paid to the concentration of potassium in the blood. Hyperkalemiawas revealed in 3% of the finerenone group; however, no lethal cases were recorded due to this reason. Before starting treatment and during the therapy process, doctors constantly monitored kidney function and arterial pressure. It should be taken into account that the use of Kerendia is contraindicated in cases of Addison’s disease and in combination with certain potent medications (e.g., CYP3A4 inhibitors).
