BACKGROUND: Finerenone is a selective, nonsteroidal mineralocorticoid receptor antagonist for treating chronic kidney disease (CKD) in patients with type 2 diabetes (T2D). Although pivotal trials demonstrated efficacy of finerenone, evidence about real-world cardiovascular (CV) effectiveness and safety is lacking.
PURPOSE: To assess effectiveness and safety of finerenone in patients with CKD and T2D by estimating the risk of key clinical and safety outcomes in finerenone initiators compared with nonusers.
METHODS: A new user cohort study identified adults with CKD and T2D in linked, closed administrative claims, electronic health records, and laboratory data from the US. Finerenone initiators were propensity-score matched with nonusers (nonusers anchored on the date of a recorded CKD diagnosis; multiple dates per individual allowed). Patients were followed until study end, loss to follow-up, or deviation from the treatment strategy. Effectiveness outcomes included composite CV outcome (hospital diagnosis of acute myocardial infarction [AMI] or hospitalization for heart failure [HF]); individual components of the composite outcome; newonset HF; and all-cause mortality. The safety outcome was hyperkalemia. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated in matched cohorts using Cox proportional hazards models with inverse probability of censoring (IPC) weights. Time-specific risk ratios (RRs) and risk differences (RDs) were estimated from the IPC-weighted cumulative incidence function. Subgroup analyses were performed by key demographic and clinical factors.
RESULTS: We identified 14,287 eligible finerenone initiators and 57,148 matched nonusers overall (mean age, 66 years; male, 53%). After matching, baseline characteristics were well balanced between treatment groups (e.g., 28% in each group with congestive HF; 24% with cerebrovascular disease). Finerenone initiators had lower risk of the composite CV outcome (HR, 0.89; 95% CI, 0.79- 1.00), driven by a lower risk of HF hospitalization (HR, 0.84; 95% CI, 0.73-0.96). HRs for AMI, new-onset HF, and all-cause mortality were attenuated or null. Finerenone initiators were more likely to experience hyperkalemia (HR, 1.47; 95% CI, 1.31-1.65). Timespecific RR estimates closely aligned with the HR estimates. RD estimates demonstrated reduction in risk of composite CV and HF hospitalization outcomes throughout follow-up. Results were generally consistent across subgroups.
CONCLUSIONS: In real-world patients with CKD and T2D, finerenone initiators had a reduced risk of HF hospitalizations. Finerenone was associated with an increased risk of hyperkalemia.
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