Cardiometabolic & kidneyMeta-analysis

Modifiability of Composite Cardiovascular Risk Associated With Chronic Kidney Disease in Type 2 Diabetes With Finerenone

JAMA CardiolPublished

  • Secondary analysis of the FIDELITY pooled analysis of randomised trials
  • pooled analysis of 2 phase 3 trials
  • population-level simulation with NHANES data

Authors' conclusion

Results of this subanalysis of the FIDELITY analysis suggest that CKD-associated composite cardiovascular risk may be modifiable with finerenone treatment in patients with T2D, those with eGFR of 25 or higher, and those with UACR of 30 mg/g or greater.

Study context

Population
Patients with T2D and chronic kidney disease (CKD)
Participants
13,026 patients
Comparison
Finerenone vs placebo
Outcome
Composite CV events (CV death, nonfatal stroke, nonfatal MI or hospitalization for HF), by eGFR and albuminuria categories
Follow-up
Median 3.0 years

Pooled result

Composite CV events

Hazard ratio

0.86

95% CI 0.78–0.95

P = 0.002

Finerenone vs Placebo
HR 0.86 (95% CI 0.78–0.95); P = 0.002

As reported in the abstract

Further pooled results

CV events incidence, Placebo, eGFR ≥90, by UACR · median 3.0 years

  • CV events incidence, Placebo, estimated glomerular filtration rate (eGFR) ≥90, by urine albumin to creatinine ratio (UACR): Lower eGFR and higher albuminuria associated with higher CV event incidence

CV events incidence, Placebo, eGFR <30, by UACR · median 3.0 years

Placebo, eGFR <30, UACR <300 mg/g: incidence per 100 patient-years
6.54 (95% CI 4.19-9.40)
Placebo, eGFR <30, UACR ≥300 mg/g: incidence per 100 patient-years
8.74 (95% CI 6.78-10.93)

Simulated CV events prevented by 1 year of finerenone (population level)

Treatment-eligible individuals
6.4 million (95% CI 5.4-7.4 million)
CV events prevented
38 359 (95% CI 31 741-44 852)
HF hospitalizations prevented
approximately 14 000
Prevented in eGFR ≥60 (25 357 of 38 360)
66%
  • simulation with NHANES data

Original publication

Modifiability of Composite Cardiovascular Risk Associated With Chronic Kidney Disease in Type 2 Diabetes With Finerenone. JAMA Cardiol. Published 1 August 2023. doi:10.1001/jamacardio.2023.1505

Summarised from the published abstract; every number is checked against it