A FIDELITY posthoc analysis of the results of the combined finerenone randomised controlled trials (RCTs) has found that the drug is as effective for treating chronic kidney disease (CKD) and type 2 diabetes (T2D) in Hispanic patient populations as in non-Hispanic White patients—but that kidney decline remains quicker for the former. The results have prompted the authors, led by Sylvia E Rosas (Joslin Diabetes Center and Harvard Medical School, Boston, USA) and published in Kidney Medicine, to argue that these patients need greater representation in CKD research.
Rosas et al note that Hispanic patients “have a higher risk of CKD progression compared with non-Hispanic White patients”, with twofold higher rates of kidney failure for Hispanic patients.
“Despite this significant burden of CKD and T2D in the Hispanic population, Hispanic patients are underrepresented in USA-based clinical trials, and few clinical trials have enrolled a sufficient number of Hispanic patients to evaluate treatments effects for CKD and T2D in this population,” the authors note.
The FIDELITY analysis has previously shown a reduced risk of CKD progression “across a broad spectrum of patients”. This post hoc analysis has investigated whether this advantage remains consistent in Hispanic patients with CKD and T2D.
From 13,026 included patients, 2,099 (16.1%) self-identified as Hispanic, 1,065 (50.7%) of which received finerenone and 1,034 (49.3%) of which received placebo. The authors note that for Hispanic patients, mean adherence was 87.8% for those receiving finerenone and 90.3% for those receiving placebo, while the rates were 92.5% and 93.2% respectively for non-Hispanic patients. Median follow-up, they add, was 2.6 years for Hispanic patients (interquartile range [IQR], 0.03–4.99 years) and 3.1 years for non-Hispanic patients (IQR, 0.03–5.11 years).
The main outcomes examined by the researchers were a cardiovascular composite outcome of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and hospitalisation for heart failure, as well as a composite kidney outcome including kidney failure and estimated glomerular filtration rate (eGFR) decline or renal death.
“Hispanic individuals living in the USA may be less likely than non-Hispanic individuals to receive appropriate diabetes care and to self-monitor their disease, and may be less likely to meet guideline metrics of diabetes care, including HbA1c tests and eye and foot examinations, compared with non-Hispanic White patients,” Rosas and colleagues say. “Therefore, the comorbidity values reported in this analysis may be underestimated compared with true prevalence.”
The FIDELITY analysis, the authors argue, demonstrates the possibility of better understanding this effect through better representation for a variety of patient groups in CKD trials. Though finerenone was found effective for Hispanic patients, “further research is needed,” they conclude, “on the socioeconomic and genetic heterogeneity of the Hispanic population to increase our understanding” on the drug’s safety and effectiveness.
