Post Hoc Analyses of DKD Clinical Trials in Ethnic Minorities (Asian, Hispanic, Black) Narrative Review.

Abstract

Purpose: The burden of Diabetic kidney disease (DKD) is escalating, with a particularly adverse impact on ethnic minority populations. Clinical trials of nonsteroidal mineralocorticoid receptor antagonist (nsMRA), such as finerenone, Sodium-Glucose Transport Protein 2 Inhibitors (SGLT2i), and Glucagon-like peptide-1 receptor agonists (GLP-1RAs) have been conducted to minimize the DKD burden. The results and adequate representation of racial and ethnic minority groups in those clinical trials need special focus.

Methods: A narrative review approach was utilized, using PubMed and Google Scholar Search tools for clinical trials of finerenone and different SGLT2i in patients with DKD. Subgroup analyses based on race, ethnicity, and geographic regions were extracted from the original manuscripts of each clinical trial and its supplement. Ethnic representation was also identified from published clinical trial results on ClinicalTrials.gov. The literature review also included Post hoc analysis of those clinical trials that study the effect of these medications on different races, ethnic minorities, and geographic regions.

Findings: Post hoc analysis of clinical trials on finerenone and SGLT2i found no significant differences in the primary composite cardiorenal outcome by race/ethnicity, suggesting consistent efficacy of these medications across diverse populations. Furthermore, the overall incidence of serious adverse events or adverse events of interest in these analyses were similar by race/ethnicity, also supporting the general safety of current DKD therapies in these populations.

Implications: Post hoc analyses of pivotal trials represent the best available evidence to guide clinical decision-making for DKD therapies in minority populations. Current guidelines do not yet recommend special considerations based on race or ethnicity. Instead, the community can gather contemporaneous real-world evidence of these agents in the minority and high-risk populations to provide valuable information about potential treatment and adverse effects by race/ethnicity.