Finerenone

(Kerendia®)

Kerendia®

Drug updated on 9/4/2024

Dosage FormTablets (oral; 10 mg, 20 mg)
Drug ClassNon-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).

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Summary
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  • 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 TitleYearSource
Kerendia (finerenone) Prescribing Information.2022Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Effects of finerenone and glucagon-like peptide 1 receptor agonists on cardiovascular and renal outcomes in type 2 diabetes mellitus: a systematic review and meta-analysis.2024Diabetology & Metabolic Syndrome
Finerenone in type 2 diabetes and renal outcomes: A random-effects model meta-analysis.2023Frontiers in Endocrinology
Efficacy and safety of finerenone for prevention of cardiovascular events in type 2 diabetes mellitus with chronic kidney disease: a meta-analysis of randomized controlled trials.2023Journal of Cardiovascular Pharmacology
Efficacy and safety of finerenone in chronic kidney disease and type 2 diabetes patients: a systematic review and meta-analysis.2023Annals of Medicine & Surgery
A systematic review and meta-analysis on the efficacy and safety of finerenone therapy in patients with cardiovascular and chronic kidney diseases in type 2 diabetes mellitus.2023Cureus
Benefits and harms of drug treatment for type 2 diabetes: Systematic review and network meta-analysis of randomised controlled trials.2023BMJ (Clinical Research ed.)
Network meta-analysis of mineralocorticoid receptor antagonists for diabetic kidney disease.2022Frontiers in Pharmacology
Finerenone in diabetic kidney disease: a systematic review and critical appraisal.2022Diabetes & Metabolic Syndrome
Efficacy and safety of finerenone in chronic kidney disease: a systematic review and meta-analysis of randomized clinical trials.2022Frontiers in Pharmacology
Meta-analysis of the efficacy and safety of finerenone in diabetic kidney disease.2022Kidney and Blood Pressure Research
Efficacy and safety of non-steroidal mineralocorticoid receptor antagonists in patients with chronic kidney disease and type 2 diabetes: a systematic review incorporating an indirect comparisons meta-analysis.2022Frontiers in Pharmacology
Efficacy and safety of finerenone in chronic kidney disease associated with type 2 diabetes: a systematic review and meta-analysis of randomized clinical trials.2022European Journal of Clinical Pharmacology
Effect of finerenone on cardiovascular events in kidney disease and/or diabetes: a meta analysis of randomized control trials.2022International Urology and Nephrology
Network meta-analysis on the effects of finerenone versus SGLT2 inhibitors and GLP-1 receptor agonists on cardiovascular and renal outcomes in patients with type 2 diabetes mellitus and chronic kidney disease.2022Cardiovascular Diabetology
Comparison the effects of finerenone and SGLT2i on cardiovascular and renal outcomes in patients with type 2 diabetes mellitus: a network meta-analysis.2022Frontiers in Endocrinology
Efficacy and safety of finerenone in patients with chronic kidney disease: a systematic review with meta-analysis and trial sequential analysis.2021Annals of Palliative Medicine
Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease.2020The Cochrane Database of Systematic Reviews
Comparative efficacy and safety of mineralocorticoid receptor antagonists in heart failure: a network meta-analysis of randomized controlled trials.2019Heart Failure Reviews

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