Finerenone in Hispanic Patients With CKD and Type 2 Diabetes: A Post Hoc FIDELITY Analysis

• Type of Material: Article
• Authors: Sylvia E. Rosas, Harvard University; Luis M. Ruilope, European University of Madrid; Stefan D. Anker, Charité Universitätsmedizin; Bertram Pitt, University of Michigan, Ann Arbor; Peter Rossing, University of Copenhagen; Andres Angelo Cadena Bonfanti, Universidad Simon Bolivar; Ricardo Correa-Rotter, Instituto Nacional de Ciencias Médicas y Nutrición Salvador; Fernando González, Universidad de Chile; Carlos Francisco Jaramillo Munoz, Colombian College of Hemodynamics and Cardiovascular Intervention; Pablo Pergola, Renal Associates; Guillermo E. Umpierrez, Emory University; Andrea Scalise, Bayer Hispania; Charlie Scott, Bayer PLC; Robert Lawatscheck, Bayer AG; Amer Joseph, Bayer AG; George L. Bakris, University of Chicago
• Language: English
• Date: 2023-08-01
• Publisher: Elsevier
• Publication Version: Final Published Version
• Copyright Statement: © 2023 The Authors
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): https://doi.org/10.1016%2Fj.xkme.2023.100704
• Title of Journal or Parent Work: Kidney Medicine
• Volume: 5
• Issue: 10
• Start Page: 100704
• Grant/Funding Information: This analysis was supported by Bayer AG, who funded the FIDELIO-DKD and FIGARO-DKD studies and the combined analysis.
• Keywords: Hispanic patients; nonsteroidal mineralocorticoid receptor antagonist; cardiorenal; finerenome; Type 2 diabetes; chronic kidney disease
• Research Categories: Health Sciences, General

Abstract

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 Patients with type 2 diabetes and CKD (urinary albumin-to-creatinine ratio [UACR] of ≥30 to <300 mg/g and estimated glomerular filtration rate [eGFR] of ≥25-≤90 mL/min/1.73 m2, or UACR of ≥300 to ≤5,000 and eGFR of ≥25 mL/min/1.73 m2) 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 Of 13,026 patients, 2,099 (16.1%) self-identified as Hispanic. Median follow-up was 3.0 years. The cardiovascular composite outcome occurred in 10.0% of Hispanic patients receiving Finerenone and in 12.3% of Hispanic patients receiving placebo (HR, 0.80; 95% CI, 0.62-1.04). This was consistent with non-Hispanic patients (HR, 0.87; 95% CI, 0.79-0.97; Pinteraction= 0.59). The kidney composite outcome occurred in 6.5% and 6.6% of Hispanic patients with finerenone and placebo, respectively (HR, 0.94; 95% CI, 0.67-1.33). The risk reduction was consistent with that observed in non-Hispanic patients (HR, 0.75; 95% CI, 0.64-0.87; Pinteraction= 0.22). Finerenone reduced UACR by 32% at month 4 in both Hispanic and non-Hispanic patients versus placebo (P < 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.