Cardiometabolic & kidney

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 result · Composite CV eventsResult — go to the resultHazard ratio 0.86 95% CI 0.78–0.95

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
  • Hospitalization for HF
by eGFR and albuminuria categories
Follow-up
Median 3.0 years
Methodological detailspooled analysis of 2 phase 3 trials, population-level simulation with NHANES data
  • Pooled analysis of 2 phase 3 trials
  • Population-level simulation with NHANES data

Pooled result

Composite CV events

Hazard ratio

0.86

95% CI 0.78–0.95

P = 0.002

Finerenonevs 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
per 100 patient-years
Placebo, UACR <300 mg/g
2.38 (95% CI 1.03–4.29) per 100 patient-years
Placebo, UACR ≥300 mg/g
3.78 (95% CI 2.91–4.75) per 100 patient-years
  • 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
≈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

Composed by AI from the published abstract and checked against it. How Briefs are made →

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