Pharmacokinetics and pharmacodynamics of finerenone in patients with chronic kidney disease and type 2 diabetes: Insights based on FIGARO‐DKD and FIDELIO‐DKD
Authors' conclusion
The analyses provide strong evidence for the effectiveness of finerenone dose titration in controlling serum potassium elevations. UACR and eGFR are predictive of kidney outcomes during finerenone treatment. Finerenone's kidney efficacy is independent of concomitant use of SGLT2 inhibitors and GLP-1RAs.
Study context
- Population
- Participants with T2D from global sites, estimated glomerular filtration rate (eGFR) 25 to 90 mL/min/1.73 m², urine albumin-creatinine ratio (UACR) 30 to 5000 mg/g, serum potassium ≤ 4.8 mmol/L
- Participants
- 13,026 participants2 phase 3 RCTs
- Comparison
- Titrated finerenone 10 or 20 mg vs placebo on top of standard of care
Methodological detailsrandomized, double-blind, placebo-controlled, phase 3, nonlinear mixed-effects population pharmacokinetic (PK)/pharmacodynamic (PD) and parametric time-to-event models
- Randomized
- Double-blind
- Placebo-controlled
- Phase 3
- Nonlinear mixed-effects population PK/PD and parametric time-to-event models
Primary result
As reported in the abstract
Dose-exposure-response of finerenone
Share of finerenone's effect on chronic eGFR decline explained by modelled UACR
95%
Share of finerenone's effect on kidney outcomes explained by modelled eGFR
87%
Further findings
Effect modification by SGLT2 inhibitor or GLP-1RA treatment
- Neither SGLT2 inhibitor nor GLP-1RA treatment significantly modified finerenone's effects on UACR and eGFR decline
Safety
- Lower serum potassium and lower hyperkalaemia rates with finerenone 20 mg vs 10 mg (attributed to potassium-guided titration)
- P < 0.001
Original publication
Pharmacokinetics and pharmacodynamics of finerenone in patients with chronic kidney disease and type 2 diabetes: Insights based on FIGARO‐DKD and FIDELIO‐DKD. Diabetes Obes Metab. Published 30 November 2023. doi:10.
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