Heart failure (HF) remains a predominant public health challenge, affecting millions globally and associated with significant morbidity and mortality. The recent trials investigating new therapeutic agents have drawn considerable attention, particularly finerenone (Kerendia), a non-steroidal, selective mineralocorticoid receptor antagonist. Initially approved for chronic kidney disease (CKD) linked with type 2 diabetes, finerenone has been studied for its potential benefits in heart failure with mildly reduced or preserved ejection fraction. However, findings from the secondary analysis of the FINEARTS-HF trial raise essential questions about its efficacy in the renal context for these patients.
The FINEARTS-HF trial aimed to observe the effects of finerenone on various health outcomes, particularly renal function, in patients suffering from heart failure. The secondary analysis presented at the American Society of Nephrology Kidney Week showed unexpected results. The primary composite kidney outcome—a significant decline in estimated glomerular filtration rate (eGFR) or development of kidney failure—occurred more frequently in patients taking finerenone compared to those on placebo (75 versus 55 events, hazard ratio 1.33). This contradicted the anticipated benefits of the drug, suggesting that it may not confer the renal protective effects previously assumed.
This outcome is noteworthy for clinicians, as it illuminates the necessity of cautious optimism when evaluating new treatments in populations already considered low-risk for significant renal deterioration. Chronic kidney disease coexists in approximately half of patients with heart failure, posing additional challenges related to management and outcomes. Thus, despite in-depth analysis, the findings raised concerns about the appropriateness of finerenone, especially when weighed against the backdrop of associated risks for adverse kidney events.
Despite the lack of significant improvement in composite kidney outcomes, finerenone displayed some success in modulating albuminuria. The drug significantly decreased the incidence of new-onset microalbuminuria and macroalbuminuria when compared with placebo. This suggests that while finerenone may not efficiently lower the eGFR decline, it can effectively manage one of the predictors for cardiovascular and renal outcomes in the heart failure patient population—albuminuria.
An important reflection on these findings is presented by Dr. Ian de Boer, who posits that while the medication’s ability to lower albuminuria could eventually yield long-term renal benefits, the immediate risk-to-benefit ratio remains unclear in a low-risk kidney cohort. Given that chronic kidney disease is a progressive condition frequently evolving over years to decades, long follow-up periods would be required to ascertain if these early benefits in albuminuria translate into improved eGFR outcomes in the long run.
Analyzing the demographics of the FINEARTS-HF trial participants reveals a patient population that is predominantly older and reflects a clinical reality faced by many healthcare providers. The mean age of participants was approximately 69 years, with varying baseline eGFR measurements. The design of the trial—including the requirement for participants to exhibit evidence of structural heart disease—adds insight into the complexities of their conditions. Though this makes for a robust clinical trial dataset, it also raises questions about generalizability to more diverse populations.
Additionally, the fact that the treatment group experienced an acute decline in eGFR during the initial three months prompts careful consideration of the risks associated with finerenone. While the frequency of serious adverse events was comparable between the treatment and placebo groups, the initial decline could deter physicians from adopting finerenone in similar patient demographics despite its long-term potential.
The FINEARTS-HF trial underscores the complexity of treating heart failure, especially among patients with concomitant renal impairment. Although finerenone shows promise in reducing albuminuria, its minimal renal benefits, as evidenced by this analysis, should temper expectations regarding its overall efficacy in patients with mildly reduced or preserved ejection fraction.
Looking forward, further longitudinal studies are warranted to explore the long-term implications of finerenone treatment on renal outcomes exclusively, ensuring that future clinical decisions are rooted in a thorough understanding of patient risk profiles. As the landscape of heart failure treatment continues to evolve, understanding the nuanced balance between efficacy and safety will be crucial in improving patient outcomes.