Efficacy and Safety of Finerenone in Patients with Chronic Kidney Disease and Type 2 Diabetes By Diuretic Use: A FIDELITY Analysis
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
Methodological detailsphase III, randomized 1:1
- Phase III
- Randomized 1:1
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.
Summarised from the published abstract; every number is checked against it