Drug updated on 12/11/2024
Dosage Form | Tablet (oral; 10 mg, 20 mg) |
Drug Class | Non-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).
Latest News
Summary
- 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 Title | Year | Source |
---|---|---|
Kerendia (finerenone) Prescribing Information. | 2022 | Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ |