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Vice Chair & Allen I. White Distinguished Professor
Department of Pharmacotherapy
College of Pharmacy and Pharmaceutical Sciences
Washington State University
Joshua J. Neumiller, PharmD, CDCES, FADCES, FASCP: consultant/advisor/speaker: Bayer, Dexcom, Novo Nordisk, Sanofi.
Overactivation of the mineralocorticoid receptor has been implicated in the pathogenesis of chronic kidney disease (CKD) in patients with type 2 diabetes (T2D). Finerenone, a novel nonsteroidal mineralocorticoid receptor antagonist (MRA), was approved by the FDA in 2021 to reduce the risk of sustained decline in estimated glomerular filtration rate, end-stage kidney disease, cardiovascular (CV) death, nonfatal myocardial infarction, and hospitalization for heart failure in adults with CKD associated with T2D (Table). Finerenone acts as a bulky, passive antagonist at the mineralocorticoid receptor that, in conjunction with its unique physicochemical properties, differentiates it from steroidal MRAs such as spironolactone and eplerenone. Of importance, finerenone has demonstrated a lower risk for contributing to hyperkalemia when compared with steroidal MRAs.
The approval of finerenone was primarily supported by 2 large and complementary phase III outcome trials studying finerenone as add-on to background angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker therapy in patients with T2D and CKD. The FIDELIO-DKD trial randomized 5734 participants to receive finerenone or placebo. During a median 2.6 years of follow-up, finerenone reduced the risk of the composite primary kidney disease outcome (kidney failure, a sustained decrease in estimated glomerular filtration rate of ≥40% from baseline, or death from kidney disease) by 18% (HR: 0.82; 95% CI: 0.73-0.93; P = .001). Overall rates of hyperkalemia-related discontinuation were low in this trial (2.3% vs 0.9% in the finerenone and placebo groups, respectively).
The FIGARO-DKD trial randomized 7437 patients to finerenone or placebo. This study found that finerenone reduced the risk of the primary CV composite outcome (death from CV causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) by 13% (HR: 0.87; 95% CI: 0.76-0.98; P = .03). Rates of hyperkalemia-related discontinuation were similarly low in the FIGARO-DKD trial (1.2% with finerenone vs 0.4% with placebo).
A pooled analysis of the FIDELIO-DKD and FIGARO-DKD trials (FIDELITY) further demonstrated CV and kidney benefits in the larger cohort of patients with T2D and CKD. Together, findings from these trials support the use of finerenone as an effective intervention to improve kidney and CV outcomes in patients with T2D and CKD. The American Diabetes Association recommends finerenone as an option to reduce CKD progression and CV events in patients with T2D and CKD.
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