The treatment landscape for heart failure continues to evolve, and one of the recent entrants, Finerenone (Kerendia), a non-steroidal mineralocorticoid receptor antagonist, has raised questions regarding its effectiveness, particularly in patients with mildly reduced or preserved ejection fraction. A pivotal secondary analysis of the FINEARTS-HF trial showcased some surprising findings, revealing that the renal benefits of Finerenone may be limited among this patient group.
Heart failure with mildly reduced or preserved ejection fraction is prevalent, yet the combination of this condition with chronic kidney disease (CKD) leaves patients particularly vulnerable to adverse health outcomes. In the FINEARTS-HF trial, the focus was on In the study’s prespecified kidney outcome, a worrying trend emerged. The analysis indicated that those treated with Finerenone experienced a greater incidence of a composite outcome—50% or greater decline in estimated glomerular filtration rate (eGFR) or the onset of kidney failure—compared to placebo. Specifically, there were 75 occurrences in the Finerenone group versus 55 in the placebo arm, with a hazard ratio of 1.33, suggesting an association rather than a beneficial effect.
The characteristics of the patients included in the trial further complicate the interpretation of these results. McCausland highlighted that the study cohort had a relatively low baseline risk of kidney events, with around half suffering from CKD. Interestingly, the concurrent presence of albuminuria was noted to be a strong predictor of adverse cardiovascular and kidney outcomes. This fact raises an important consideration; treating a patient population already identified as low risk might inherently limit the observable improvements in kidney function that one might hope to achieve with novel pharmacotherapies like Finerenone.
The demographics of the participants in the study showed a clear trend: the majority were older patients with a high incidence of previous heart failure-related hospitalizations. This demographic reality cannot be overlooked when evaluating treatment efficacy or potential improvements in health outcomes.
While the overall results related to renal outcomes were disappointing, a more nuanced picture emerged when considering specific indicators of kidney health. Finerenone demonstrated a notable reduction in the risk of developing microalbuminuria and macroalbuminuria, with hazard ratios of 0.76 and 0.62, respectively. Additionally, participants in the Finerenone group exhibited a significant reduction—30%—in the urine albumin-creatinine ratio (UACR) at the six-month mark, a reduction that appeared to be sustained over the three-year follow-up period.
These findings prompt further speculation about the long-term implications of reduced albuminuria. Ian de Boer, MD, suggested that the initial drop in albumin levels might correlate with eventual improvements in eGFR over an extended timeline. Nonetheless, the expectation for substantial eGFR benefits remains tempered by the understanding that CKD typically progresses over many years. Thus, the follow-up in this analysis might have been too brief to gauge the long-lasting effects of the treatment fully.
Serious Adverse Events and Treatment Considerations
Examining the safety profile of Finerenone in this trial provided additional insights. The incidence of serious adverse events was comparable between participants receiving Finerenone and those on placebo, which highlights its relative safety. However, early treatment led to a significant acute decline in eGFR, typically observed within the first three months. This phenomenon underscores the need for careful patient selection and monitoring during treatment initiation.
Particularly for patients with lower baseline eGFR, there was a heightened frequency of serious elevations in serum creatinine and incidents of hyperkalemia, reinforcing the importance of assessing individual risk factors before commencing treatment with Finerenone.
While Finerenone offers some promise in reducing albuminuria, its overall effects on renal outcomes among patients with mildly reduced or preserved ejection fraction appear limited. The FINEARTS-HF trial challenges some initial expectations, raising critical questions about the role of such therapies in a low-risk patient population.
As heart failure treatment strategies continue to advance, understanding the full scope of benefits and limitations associated with medications like Finerenone will be essential. Future studies, ideally with extended follow-up periods and a broader range of risk stratification, are vital for corroborating the potential long-term advantages we may expect from this and similar therapies in managing heart failure and concurrent kidney disease.
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