Key result
Finerenone improves cardiorenal outcomes equally in Hispanic and non-Hispanic patients with CKD and T2D.
Why the study?
Finerenone improves cardiorenal outcomes in CKD and type 2 diabetes, but its efficacy and safety specifically in Hispanic patients needed exploration.
Does finerenone improve cardiovascular and kidney outcomes in Hispanic patients with CKD and type 2 diabetes?
RCT
Does finerenone improve cardiovascular and kidney outcomes in Hispanic patients with CKD and type 2 diabetes?
Finerenone provides similar cardiovascular and kidney benefits with a comparable safety profile in Hispanic patients with CKD and type 2 diabetes as in non-Hispanic patients.
Finerenone may confer similar cardiorenal benefits in Hispanic patients; extends evidence to this subgroup but remains hypothesis-generating.
Rationale & Objective: In FIDELITY, finerenone improved cardiorenal outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes. This analysis explores the efficacy and safety of finerenone in Hispanic patients. Study Design: Post hoc analysis of the FIDELITY prespecified pooled analysis of the FIDELIO-DKD and FIGARO-DKD randomized control trials. Setting & Participants: ) on optimized renin-angiotensin system blockade. Intervention: Finerenone or placebo. Outcomes: Cardiovascular composite (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure); kidney composite (kidney failure, sustained ≥57% eGFR decline, or renal death); change in UACR. Results: < 0.001 for both patient groups). The safety profile of finerenone and incidence of hyperkalemia was similar between Hispanic and non-Hispanic patient groups. Limitations: Small sample size, short follow-up time, and lower treatment adherence in the Hispanic population. Conclusions: Overall, the efficacy and safety of finerenone were similar in Hispanic and non-Hispanic patients with CKD and type 2 diabetes. Funding: Bayer AG. Trial Registration: ClinicalTrials.gov identifier: NCT02540993, NCT02545049. Plain-Language Summary: Chronic kidney disease (CKD) in patients with type 2 diabetes occurs more frequently in Hispanic patients than in non-Hispanic patients, with a more rapid progression to kidney failure. Treatment with finerenone reduces the risk of having a kidney or heart event (such as starting dialysis or having a heart attack) in patients with CKD and type 2 diabetes. Because clinical trials that investigate treatments for CKD and type 2 diabetes have not included enough Hispanic patients, the benefits of treatments particularly for Hispanic patients are frequently unknown. This study explores the benefits of finerenone in Hispanic patients. Overall, the study shows that finerenone can provide kidney and heart benefits in Hispanic patients with CKD and type 2 diabetes, as it does in non-Hispanic patients.
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Rosas et al. (2023) conducted an RCT in Chronic kidney disease (CKD) and type 2 diabetes. Finerenone vs. Placebo was evaluated on Cardiovascular composite (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure); kidney composite (kidney failure, sustained ≥57% eGFR decline, or renal death); change in UACR (p=< 0.001). Finerenone demonstrated similar efficacy and safety in Hispanic and non-Hispanic patients with CKD and type 2 diabetes, significantly improving cardiorenal outcomes (P<0.001).
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