Common side effects include hyperkalemia (high levels of potassium) (normal 3.5-5.5mg/dl), hypotension (low blood pressure), and hyponatremia (low levels of sodium).[8]
In the United States, finerenone is indicated to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with type2 diabetes.[8]
In the European Union, finerenone is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type2 diabetes in adults.[9]
This table compares inhibitory (blocking) concentrations (IC50, unit: nM) of three antimineralocorticoids. Mineralocorticoid receptor inhibition is responsible for the desired action of the drugs, whereas inhibition of the other receptors potentially leads to side effects. Lower values mean stronger inhibition.[14]
Finerenone acts as an antagonist to mineralocorticoid receptors harboring the S810L mutation, unlike other traditional MR inhibitors such as spironolactone and eplerenone that incidentally act as agonists.[15]
A meta-analysis of data from seven randomized controlled trials (13,783 participants) found a benefit to using finerenone in people with diabetic kidney disease and overt proteinuria.[16]
Adverse effects
Finerenone may cause electrolyte imbalances.[17] Symptoms that correlate with higher levels of potassium include nausea, weakness, chest pain, and loss of movement.[17] People with lower levels of sodium may experience headaches, confusion, weakness, and feeling off balance.[17]
History
The efficacy of finerenone to improve kidney and heart outcomes was evaluated in a randomized, multicenter, double-blind, placebo-controlled study in adults with chronic kidney disease associated with type2 diabetes.[8] In this study, 5,674 participants were randomly assigned to receive either finerenone or a placebo.[8]
The study compared the two groups for the number of participants whose disease progressed to a composite (or combined) endpoint that included at least a 40% reduction in kidney function, progression to kidney failure, or kidney death.[8] Results showed that 504 of the 2,833 participants who received finerenone had at least one of the events in the composite endpoint compared to 600 of the 2,841 participants who received a placebo.[8]
In December 2021, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Kerendia, intended for the treatment of chronic kidney disease associated with type2 diabetes in adults.[18] The applicant for this medicinal product is Bayer AG.[18] Finerenone was approved for medical use in the European Union in February 2022.[9][19]
Brand names
Finerenone is sold under the brand names Kerendia and Firialta.[20]
Research
In the phase II ARTS-DN study, finerenone dose-dependently reduced urine albumin to creatinine ratio in patients with diabetic kidney disease.[21] Based on these findings, finerenone is being studied in the large Phase III FIDELIO and FIGARO outcome studies designed to assess whether finerenone reduces risk of CKD progression and adverse cardiovascular events in patients with Chronic Kidney Disease and Type 2 Diabetes. These trials have enrolled more than 13,000 patients with primary completion of FIDELIO anticipated in 2020 and FIGARO IN 2021.[22][full citation needed][23][full citation needed]
^ abcd"Kerendia EPAR". European Medicines Agency (EMA). 14 December 2021. Retrieved 11 March 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^Bärfacker L, Kuhl A, Hillisch A, Grosser R, Figueroa-Pérez S, Heckroth H, et al. (August 2012). "Discovery of BAY 94-8862: a nonsteroidal antagonist of the mineralocorticoid receptor for the treatment of cardiorenal diseases". ChemMedChem. 7 (8): 1385–1403. doi:10.1002/cmdc.201200081. PMID22791416. S2CID36084480.{{cite journal}}: CS1 maint: overridden setting (link)
^ ab"Kerendia: Pending EC decision". European Medicines Agency (EMA). 16 December 2021. Archived from the original on 28 October 2022. Retrieved 18 December 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^Clinical trial number NCT02540993 for "Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (FIDELIO-DKD)" at ClinicalTrials.gov
^Clinical trial number NCT02545049 for "Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease (FIGARO-DKD)" at ClinicalTrials.gov
