Daily Dose: Finerenone Reduces CKD-associated CV Risk in Patients with T2D

Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.

On June 14, 2023, we reported on a study published in JAMA Cardiology that examined whether cardiovascular (CV) risk can be modified with finerenone in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD).

The study

Researchers analyzed data from FIDELITY, a prespecified pooled analysis of results from 2 large phase 3 randomized clinical trials with finerenone, FIDELIO-DKD and FIGARO-DKD, which together examined CV and renal outcomes across a broad spectrum of CKD severity in patients with T2D.

They combined incidence rates of CV events from FIDELITY with data from the National Health and Nutrition Examination Survey (2015-2016 and 2017-2018) to simulate the number of composite CV events that may be prevented each year with finerenone.

The primary outcome was a composite of CV outcomes including CV death, nonfatal stroke, nonfatal myocardial infarction, or hospitalization for heart failure (HF) during a median of 3 years by eGFR and albuminuria categories.

The findings

A total of 13 026 patients (mean age, 64.8 years; 69.8% men) were included in the analysis. Investigators observed that a lower eGFR and higher albuminuria were associated with higher incidences of CV events.

Among participants in the placebo group with an eGFR of ≥90, incident CV event rates per 100 patient-years were 2.38 (95% CI 1.03-4.29) in those with a urine albumin to creatinine ratio (UACR) <300 mg/g and 3.78 (95% CI 2.91-4.75) in those with a UACR of ≥300 mg/g. Among patients with an eGFR of <30, incidence rates increased to 6.54 per 100 patient-years (95% CI 4.19-9.40) in those with a UACR of <300 mg/g and to 8.74 per 100 patient-years (95% CI 6.78-10.93) in those with a UACR of ≥300 mg/g.

Finerenone was associated with a reduction in composite CV risk (hazard ratio [HR] 0.86, 95% CI 0.78-0.95; P=.002) regardless of eGFR and UACR (P for interaction=.66).

When researchers used nationally representative data from 6.4 million persons eligible for treatment with finerenone, they noted that 1 year of treatment was simulated to prevent 38 359 CV events, including approximately 14 000 hospitalizations for HF, of which 66% could be prevented in patients with albuminuria and eGFR ≥60.

Clinical implications

“The observation of an elevated, but modifiable, composite cardiovascular risk in patients with eGFR of 60 or greater but with moderately to severely increased albuminuria has significant implications for clinical practice. Despite recommendations in guidelines to screen both eGFR and albuminuria at least annually in patients with T2D, real-world evidence indicates that levels of screening for albuminuria in patients with CKD or T2D in clinical practice are very low. Although the importance of albuminuria as a risk factor for cardiovascular events is well known, the findings presented here indicate the ability to modify this risk to reduce morbidity and mortality, highlighting the urgency to improve rates of albuminuria testing irrespective of a patient’s eGFR."

Click here for more details.