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期刊来源：Nat Med

原文链接：https://doi.org/10.1038/s41591-024-02941-8

摘要内容如下：

WIN统计提供了一种分析临床试验结果的新方法，允许结合时间-事件和纵向测量，并考虑复合结果成分的临床重要性及其相对时间。我们在两项试验的事后分析中检验了这一方法，这两项试验比较了达格列嗪与安慰剂对射血分数降低（DAPA-HF）和射血分数轻度降低或维持（Deliver）的心力衰竭患者的疗效。我们评估了达格列嗪对分级复合肾脏结局的影响，包括：（1）全因死亡率；（2）终末期肾脏病；（3）肾小球滤过率估计值（EGFR）下降≥57%；（4）EGFR下降≥50%；（5）EGFR下降≥40%；和（6）参与者水平EGFR斜率。对于该结果，组合数据集中的赢率为1.10（95%置信区间（CI）=1.06-1.15），DAPA-HF试验中的赢率为1.08（95%CI=1.01-1.16），Deliver试验中的赢率为1.12（95%CI=1.05-1.18）；也就是说，在两项试验中，达格列嗪均优于安慰剂。在患有和未患有基线肾脏疾病以及患有和未患有2型糖尿病的参与者中，治疗的益处是一致的。在心力衰竭试验中，WIN统计可以提供评估治疗对肾脏和心血管结局的影响的统计能力。

英文原文如下：

Abstracts

Win statistics offer a new approach to the analysis of outcomes in clinical trials, allowing the combination of time-to-event and longitudinal measurements and taking into account the clinical importance of the components of composite outcomes, as well as their relative timing. We examined this approach in a post hoc analysis of two trials that compared dapagliflozin to placebo in patients with heart failure and reduced ejection fraction (DAPA-HF) and mildly reduced or preserved ejection fraction (DELIVER). The effect of dapagliflozin on a hierarchical composite kidney outcome was assessed, including the following: (1) all-cause mortality; (2) end-stage kidney disease; (3) a decline in estimated glomerular filtration rate (eGFR) of ≥57%; (4) a decline in eGFR of ≥50%; (5) a decline in eGFR of ≥40%; and (6) participant-level eGFR slope. For this outcome, the win ratio was 1.10 (95% confidence interval (CI) = 1.06-1.15) in the combined dataset, 1.08 (95% CI = 1.01-1.16) in the DAPA-HF trial and 1.12 (95% CI = 1.05-1.18) in the DELIVER trial; that is, dapagliflozin was superior to placebo in both trials. The benefits of treatment were consistent in participants with and without baseline kidney disease, and with and without type 2 diabetes. In heart failure trials, win statistics may provide the statistical power to evaluate the effect of treatments on kidney as well as cardiovascular outcomes.

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