Cardiometabolic & kidneyMeta-analysis
Efficacy and Safety of Finerenone in Patients with Chronic Kidney Disease and Type 2 Diabetes By Diuretic Use: A FIDELITY Analysis
- Post hoc subgroup analysis of FIDELITY, a pre-specified pooled analysis of the FIDELIO-DKD and FIGARO-DKD randomised trials
- phase III
- randomized 1:1
Authors' conclusion
This analysis showed that the efficacy and safety of finerenone in patients with CKD and T2D was not modified by baseline diuretic use.
Study context
- Population
- Patients with T2DM and chronic kidney disease (CKD) (UACR ≥30-<300 mg/g and eGFR ≥25-≤90 ml/min/1.73 m², or UACR ≥300-≤5000 mg/g and eGFR ≥25 ml/min/1.73 m²)51.6% on diuretics
- Participants
- 12,990 patients
- Comparison
- Finerenone vs placebo, by baseline diuretic use
- Outcome
- CV composite (CV death, non-fatal MI, non-fatal stroke or HF hospitalization) and kidney composite (kidney failure, sustained ≥57% eGFR decrease or kidney-related death), by baseline diuretic use
Pooled result
As reported in the abstract
CV and kidney composites by baseline diuretic use
Diuretic use did not modify the effect on the CV outcome
p-interaction = 0.94
Diuretic use did not modify the effect on the kidney outcome
p-interaction = 0.55
Safety
Hyperkalaemia, with diuretics
Hyperkalaemia, without diuretics
- Hyperkalaemia, with diuretics: similar between finerenone subgroups irrespective of diuretic use
Hyperkalaemia leading to hospitalization or study drug discontinuation
- Low across treatment groups irrespective of diuretic use
Original publication
Efficacy and Safety of Finerenone in Patients with Chronic Kidney Disease and Type 2 Diabetes By Diuretic Use: A FIDELITY Analysis. Eur J Heart Fail. Published 17 January 2025. doi:10.1002/ejhf.3569
Summarised from the published abstract; every number is checked against it