Cardiometabolic & kidneyMeta-analysis
Fragility analysis of cardiovascular outcomes with finerenone in patients with Type 2 diabetes mellitus and chronic kidney disease
- Systematic review of randomised trials with fragility analysis
- placebo-controlled
- phase 3 or 4
- MEDLINE and Scopus searched from inception to June 2025
Authors' conclusion
Finerenone significantly reduces HF hospitalization and modestly improves composite CV outcomes in T2DM with CKD, but effects on CV death, MI, and stroke are fragile.
Study context
- Population
- Patients with T2DM and chronic kidney disease (CKD)3 trials
- Comparison
- Finerenone vs placebo
- Outcome
- Composite CV outcome (CV death, non-fatal MI, non-fatal stroke, HF hospitalization): robustness by fragility metrics
Pooled result
As reported in the abstract
Primary composite CV outcome:
- CV death
- Non-fatal MI
- Non-fatal stroke
- HFH
- FIDELIO-DKD: significantly reduced, HR
- 0.86
- FIDELIO-DKD: NNT
- 56
- FIDELIO-DKD: Fragility index (FI)
- 4
- FIDELIO-DKD: Fragility quotient (FQ)
- 0.0007
- FIDELITY: significantly reduced, HR
- 0.86
- FIDELITY: NNT
- 59
- FIDELITY: FI
- 38
- FIDELITY: FQ
- 0.002
- FIGARO-DKD: not significantly reduced, HR
- 0.87
- FIGARO-DKD: Reverse fragility index (RFI)
- 7
- FIGARO-DKD: Reverse fragility quotient (RFQ)
- 0.0009
Further pooled results
HFH (most consistent and robust benefit)
- FIDELITY: HR
- 0.78
- FIDELITY: NNT
- 91
- FIDELITY: FI
- 23
- FIDELITY: FQ
- 0.001
Cardiovascular (CV) death, MI, stroke
- Numerically favourable but statistically non-significant, with low RFIs (mostly 1-3, up to 9)
Original publication
Fragility analysis of cardiovascular outcomes with finerenone in patients with Type 2 diabetes mellitus and chronic kidney disease. Eur J Heart Fail. Published 5 May 2026. doi:10.1093/ejhf/xuag150
Summarised from the published abstract; every number is checked against it