FIDELITY: Real-world CV benefit of finerenone consistent regardless of ASCVD status
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WASHINGTON — Finerenone was beneficial in primary and secondary prevention across the spectrum of patients with chronic kidney disease and type 2 diabetes regardless of whether they had atherosclerotic CVD, researchers reported.
Finerenone (Kerendia, Bayer), a selective nonsteroidal mineralocorticoid receptor antagonist, is believed to have antifibrotic and anti-inflammatory effects on the CV system, Gerasimos Filippatos, MD, DHC, FESC, FHFA, FHFSA, professor of cardiology at the National and Kapodistrian University of Athens in Greece, said during a featured clinical research presentation at the American College of Cardiology Scientific Session. Data from the FIDELIO-DKD and FIGARO-DKD trials previously showed finerenone significantly improved CV outcomes and slowed chronic kidney disease (CKD) progression in patients with CKD and type 2 diabetes. The FIDELITY analysis includes a broad spectrum of more than 13,000 patients with type 2 diabetes and CKD, reflecting real-world practice and “higher analytic precision” than FIDELIO-DKD or FIGARO-DKD alone, Filippatos said.
“The FIDELITY primary analysis has been recently published, demonstrating significant risk reduction for both the CV composite and kidney outcomes with finerenone compared with placebo,” Filippatos said during the presentation. “The risk for CV morbidity and mortality was reduced by 14% vs. placebo and the risk for CKD progression was reduced by 23% vs. placebo. This presentation will focus on the effect of finerenone in a prespecified subgroup categorized by the presence or absence of ASCVD at baseline.”
Outcomes assessed by ASCVD status
Researchers analyzed data from 13,171 patients from 48 countries with type 2 diabetes and CKD treated with renin-angiotensin system inhibition and without symptomatic HF with reduced ejection fraction, randomly assigned 10 mg or 20 mg finerenone once daily or placebo and followed for a median of 3 years. Key outcomes were a CV composite endpoint of time to CV death, nonfatal MI, nonfatal stroke or HF hospitalization, as well as a composite renal endpoint of a sustained reduction in estimated glomerular filtration rate (eGFR) from baseline of at least 57% or renal death. Researchers performed prespecified subgroup analyses of FIDELITY according to ASCVD history at baseline that did not include history of HF to evaluate the efficacy and safety of finerenone in primary and secondary populations.
Within the cohort, 45.6% had a history of ASCVD at baseline.
During follow-up, finerenone lowered risk for the composite CV outcome compared with placebo, with an HR or 0.86 (95% CI, 0.78-0.95). There was no treatment modification by CVD history, with HRs of 0.83 (95% CI, 0.74-0.94) and 0.91 (95% CI, 0.78-1.06) in those with and without CVD, respectively (P for interaction = .375).
Similarly, CVD history did not modify the effect of finerenone on the composite kidney outcome, with an overall HR or 0.77 (95% CI, 0.67-0.88) and HRs of 0.71 (95% CI, 0.57-0.88) and 0.81 (95% CI, 0.68-0.97) for patients with and without CVD history, respectively (P for interaction = .325).
There were no between-group differences in adverse events; there was a low incidence of hyperkalemia-related treatment discontinuation that was more frequent in the finerenone group that did not differ by CVD history, Filippatos said.
Treatment safe, effective
“In these patients treated with optimized renin-angiotensin system therapy, finerenone significantly reduced risk for CV and kidney events, irrespective of CVD history, and it was generally well tolerated,” Filippatos said. “Overall, the data presented today indicate that finerenone may be used for both primary and secondary CVD prevention in this group of patients with type 2 diabetes and CKD as well as for protection for worsening kidney disease.”
In July, the FDA approved finerenone for lowering risk for kidney and heart complications in adults with CKD associated with type 2 diabetes.
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Filippatos G, et al. Featured Clinical Research III. Presented at: American College of Cardiology Scientific Session; April 2-4, 2022; Washington, D.C. (hybrid meeting).
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