Drug updated on 9/4/2024
Dosage Form | Tablets (oral; 10 mg, 20 mg) |
Drug Class | Non-steroidal mineralocorticoid receptor antagonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated 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 chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
Latest News
Summary
- Kerendia (finerenone) is indicated 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 chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
- This summary is based on the review of 18 systematic review(s)/meta-analysis(es). [1-18]
- Major Adverse Cardiovascular Events (MACE): Finerenone reduced the risk of MACE by 13% (HR: 0.87; 95% CI: 0.79-0.95; P=0.003) in patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD), particularly in those with established atherosclerotic cardiovascular disease (HR: 0.86; 95% CI: 0.82-0.90; P<0.001). GLP1-RA showed a similar 13% risk reduction (HR: 0.87; 95% CI: 0.83-0.92; P<0.001).
- Hospitalization for Heart Failure (HHF): Finerenone significantly reduced the risk of HHF (HR: 0.78; 95% CI: 0.66-0.92; P=0.003).
- Kidney Disease Progression: Finerenone reduced the risk of kidney disease progression by 16% (HR: 0.84; 95% CI: 0.77-0.92; P<0.001) and was more effective than GLP1-RA in delaying deterioration of kidney function.
- Comparison with Other Drugs: SGLT-2 inhibitors showed greater efficacy in reducing MACE, renal outcomes, and HHF compared to finerenone. Finerenone had comparable or slightly less efficacy in reducing MACE compared to GLP1-RA but was superior in slowing kidney disease progression.
- Finerenone significantly increased the risk of hyperkalemia (RR: 2.22; 95% CI: 1.93-2.24), with a specific increased risk compared to placebo (RR: 2.04; 95% CI: 1.80-2.32).
- The incidence of adverse events was similar between finerenone and placebo (RR: 1.00; 95% CI: 0.98-1.01), with no significant difference in serious adverse events (RR: 0.95; 95% CI: 0.92-0.97).
- Finerenone demonstrated a lower risk of sexual side effects and gynecomastia compared to spironolactone, with different safety profiles noted for SGLT-2 inhibitors and GLP-1 receptor agonists, which included risks of genital infections and gastrointestinal adverse events, respectively.
- The cardiovascular and renal benefits of finerenone were particularly significant in patients with both type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD), with the reduction in major adverse cardiovascular events (MACE) specifically notable in those with established atherosclerotic cardiovascular disease.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Kerendia (finerenone) Prescribing Information. | 2022 | Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Mineralocorticoid receptor antagonist use in chronic kidney disease with type 2 diabetes: a clinical practice document by the European Renal Best Practice (ERBP) board of the European Renal Association (ERA). | 2023 | Clinical Kidney Journal |
Finerenone added to treatment guidelines for type 2 diabetes and chronic kidney disease. | 2023 | American Journal of Nursing |
Clinical implications and guidelines for CKD in type 2 diabetes. | 2023 | Nephrology Dialysis Transplantation |