The recent results from the FINEARTS-HF trial have raised significant questions regarding the efficacy of finerenone, known commercially as Kerendia, in providing renal benefits for patients suffering from heart failure with mildly reduced or preserved ejection fraction. Despite the medication’s promising profile, a secondary analysis of the trial has shown that finerenone does not yield the anticipated renal improvements, particularly in a population already at low risk for adverse kidney events.
In the trial, researchers focused on a prespecified composite kidney outcome that included either a sustained decline of 50% or more in estimated glomerular filtration rate (eGFR) or kidney failure. The results were disappointing for finerenone, revealing a greater incidence of renal events compared to a placebo group—75 events compared to 55, yielding a hazard ratio of 1.33. A similar trend was observed when a more stringent criteria was applied; the comparison of events indicated a possible inclination towards harm rather than benefit.
Interestingly, the patient cohort was noted for their relatively low risk for adverse kidney outcomes, which is crucial context when assessing the trial’s findings. Chronic kidney disease (CKD) is present in a significant number of patients with heart failure, and these conditions are linked to heightened morbidity and mortality rates. McCausland, one of the study’s presenters, emphasized that those with CKD usually experience worse outcomes than those without, underscoring the complexity of managing renal health in heart failure patients.
While the primary kidney outcomes did not favor finerenone, it’s worth noting that the medication displayed efficacy in reducing the incidence of new-onset microalbuminuria and macroalbuminuria. Specifically, treatment with finerenone led to a reduction in the development of microalbuminuria (HR 0.76) and macroalbuminuria (HR 0.62). Furthermore, a reduction of 30% in urine albumin-creatinine ratio (UACR) was observed after six months, with the effects persisting throughout a follow-up period of 36 months.
This reduction in albuminuria sheds light on a potential indirect benefit, as Ian de Boer, a commentator not involved in the study, speculated that albuminuria decrement might translate to longer-term improvements in eGFR. Yet, he cautioned that significant benefits in eGFR remain unlikely in this specific low-risk cohort based on the results collected.
The approval of finerenone in 2021 marked a notable advancement in the treatment of heart failure associated with CKD and type 2 diabetes. Its role as the first non-steroidal, selective mineralocorticoid receptor antagonist offered hope for reducing a multitude of risks related to kidney function and cardiovascular health. However, the secondary analysis of the FINEARTS-HF trial prompts a re-evaluation of expectations surrounding this drug, specifically in the context of renal outcomes.
Notably, the initial acute decline in eGFR observed in patients during the first three months of treatment signifies a potential transient risk that must be addressed in clinical practice. The understanding that eGFR slopes reached statistical insignificance in comparisons after the initial period could influence future prescribing patterns and patient monitoring strategies. Given that elderly patients and those with lower baseline eGFRs faced higher frequencies of serious adverse events, practitioners are urged to individually weigh the benefits against potential risks.
While finerenone shows promise in specific areas, particularly regarding the reduction of albuminuria, its impact on broader renal outcomes in heart failure patients remains questionable. The results from the FINEARTS-HF trial serve as a reminder that even treatments that garner approval based on studies may not manifest similar benefits across all patient populations. The nuances of kidney health in heart failure, especially among those with preexisting conditions, necessitate a thorough understanding and tailored approaches in treatment. Continued research and long-term follow-ups will be essential in determining the full scope of finerenone’s efficacy and safety in this complex patient population.
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