Simultaneous initiation of finerenone and empagliflozin across the spectrum of kidney risk in the CONFIDENCE trial.

This prespecified analysis aimed to determine if the predicted risk of kidney disease progression, based on KDIGO risk categories, influenced the benefits and safety of this combination therapy.

这项预先设定的分析旨在确定基于KDIGO风险类别的肾脏疾病进展预测风险是否影响了这种联合疗法的益处和安全性。

Methods

The double-blind, double-dummy trial randomized 818 adults with CKD and type 2 diabetes [urine albumin-creatinine ratio (UACR) ≥100 to <5000 mg/g] to receive once-daily finerenone plus empagliflozin, finerenone alone or empagliflozin alone, all in addition to a renin-angiotensin system inhibitor.

这项双盲、双模拟试验随机选取了818名患有慢性肾脏病（CKD）和2型糖尿病（尿白蛋白-肌酐比率（UACR）≥100至<5000 mg/g）的成人，他们被随机分配接受每日一次的非奈利酮加恩格列净、单独的非奈利酮或单独的恩格列净治疗，所有这些治疗均在肾素-血管紧张素系统抑制剂的基础上进行。

The relative change in UACR from baseline to day 180 (primary endpoint) and a >30% reduction in UACR (secondary endpoint) across KDIGO risk categories was assessed.

从基线到第180天UACR的相对变化（主要终点）以及在KDIGO风险类别中UACR减少>30%（次要终点）的情况被评估。

Results

At baseline, among 781 with available data, 11.3% of participants were classified as low/moderate risk, 29.6% as high risk and 59.2% as very high risk.

基线时，在有数据的781名参与者中，11.3%被归类为低/中风险，29.6%为高风险，59.2%为非常高风险。

At 180 days, combination therapy significantly reduced UACR levels across all KDIGO risk categories (low/moderate: -61.7%; high: -60.7%; very high: -52.4%).

在180天时，联合治疗显著降低了所有KDIGO风险类别的UACR水平（低/中风险：-61.7%；高风险：-60.7%；非常高风险：-52.4%）。

This reduction was consistently greater than that achieved with either monotherapy alone.

这种减少效果始终大于任一单药治疗所达到的效果。

More than half of patients on combination therapy experienced UACR reductions of >30% (low/moderate: 58.1%; high: 74.2%; very high: 70.6%), again outperforming monotherapies across all risk groups.

超过一半的联合治疗患者尿白蛋白/肌酐比值（UACR）降低超过30%（低/中等风险组：58.1%；高风险组：74.2%；非常高风险组：70.6%），在所有风险组中均优于单药治疗。

While hyperkalemia was more common with combination therapy, early eGFR declines (>30% within 30 days) were less frequent in individuals with higher KDIGO risk compared with lower risk.

尽管联合治疗时高钾血症更为常见，但在具有较高KDIGO风险的个体中，早期eGFR下降（30天内>30%）的发生率较风险较低者为低。

Overall, the safety profile of combination therapy remained consistent across all KDIGO risk categories, with no unexpected safety signals.

总体而言，联合治疗的安全性在所有KDIGO风险类别中保持一致，没有出现意外的安全信号。

Conclusions

The CONFIDENCE trial demonstrates that the relative efficacy and safety of simultaneous finerenone and empagliflozin combination therapy are consistent across a wide spectrum of predicted kidney disease risk.

CONFIDENCE试验表明，同时使用非奈利酮和恩格列净联合疗法在预测的肾脏疾病风险广泛谱系中的相对疗效和安全性是一致的。

clinical_trial_registration

NCT05254002; EudraCT 2021-003037-11.

NCT05254002; EudraCT 2021-003037-11.