Finerenone

(Kerendia®)

Finerenone

Drug updated on 12/11/2024

Dosage FormTablet (oral; 10 mg, 20 mg)
Drug ClassNon-steroidal mineralocorticoid receptor antagonists (MRA)
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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  • This summary is based on the review of 13 systematic review(s)/meta-analysis(es). [1-13]
  • Finerenone significantly reduced the urinary albumin to creatinine ratio (UACR) (standardized mean difference (SMD): -0.49, 95% confidence interval (CI) -0.53 to -0.46, tau(2)) compared to placebo (mean difference (MD), -0.30) and showed a more pronounced reduction in UACR among Asians (weighted mean difference (WMD), -0.59) compared to non-Asians (WMD, -0.29).
  • Finerenone was associated with a decreased decline in estimated glomerular filtration rate (eGFR) compared to placebo, with a hazard ratio (HR) of 0.82 for a 40% decline and 0.70 for a 57% decline in eGFR.
  • Finerenone reduced the risk of major adverse cardiovascular events (MACE) by 13% (HR, 0.87) and significantly reduced the risk of hospitalization for heart failure (HR, 0.78), showing superior benefits in heart failure outcomes compared to glucagon-like peptide 1 (GLP-1)-receptor agonist (RA) (Type 2 Diabetes Mellitus (T2DM)) and sodium glucose cotransporter 2 (SGLT2) inhibitors (SGLT2i).
  • Finerenone reduced the risk of kidney disease progression (HR, 0.84), with similar effectiveness to GLP1-RA (HR, 0.81) in delaying the progression of kidney disease.
  • Finerenone was associated with a higher incidence of hyperkalemia compared to placebo (relative risk (RR) 2.03), with Asians showing a higher incidence of hyperkalemia compared to non-Asians.
  • Finerenone significantly increased serum potassium levels and led to moderate hyperkalemia (odds ratio (OR) 2.25), which contributed to a higher rate of drug withdrawals due to hyperkalemia.
  • There was no significant difference in overall adverse events between finerenone and placebo, although the risk of serious adverse events was slightly reduced with finerenone (RR 0.95). However, finerenone was linked to an increased risk of malignant urinary tract neoplasms (Peto OR 1.69).
  • In patients T2DM and Chronic Kidney Disease (CKD), finerenone showed significant benefits in reducing cardiovascular and renal events, with Asians exhibiting greater reductions in urinary albumin to creatinine ratio (UACR) and systolic blood pressure (SBP) compared to non-Asians, though they also had a higher incidence of hyperkalemia.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Renal effects and safety between Asian and non-Asian chronic kidney disease and type 2 diabetes treated with nonsteroidal mineralocorticoid antagonists2024Journal of Diabetes
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-analysis2024Diabetology & Metabolic Syndrome
Tumor risks of finerenone in patients with type 2 diabetes mellitus complicated with chronic kidney disease: a meta-analysis and systematic review of randomized controlled trials2023Frontiers in Pharmacology
Efficacy and safety of finerenone in chronic kidney disease and type 2 diabetes patients: a systematic review and meta-analysis2023Annals of Medicine and 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 Mellitus2023Cureus
Finerenone in type 2 diabetes and renal outcomes: A random-effects model meta-analysis2023Frontiers in Endocrinology
Comparison the effects of finerenone and SGLT2i on cardiovascular and renal outcomes in patients with type 2 diabetes mellitus: A network meta-analysis2022Frontiers in Endocrinology
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 disease2022Cardiovascular Diabetology
Finerenone in diabetic kidney disease: A systematic review and critical appraisal2022Diabetes & Metabolic Syndrome
Network meta-analysis of mineralocorticoid receptor antagonists for diabetic kidney disease2022Frontiers in Pharmacology
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-Analysis2022Frontiers in Pharmacology
Efficacy and Safety of Finerenone in Chronic Kidney Disease: A Systematic Review and Meta-Analysis of Randomized Clinical Trials2022Frontiers in Pharmacology
Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease2020The Cochrane Database of Systematic Reviews

Clinical Practice Guidelines