Dapagliflozin improved a hierarchical composite outcome, including death, a worsening kidney disease event, and estimated glomerular filtration rate slope, compared with placebo, in patients with heart failure. This hierarchical outcome — analyzed with win statistics — might provide the statistical power to evaluate the effect of treatments on kidney function in heart failure trials.
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References
Levin, A. et al. International consensus definitions of clinical trial outcomes for kidney failure: 2020. Kidney Int. 98, 849–859 (2020). A meeting report that presents the international consensus definition of clinical trial outcomes for kidney failure.
Pocock, S. J., Ariti, C. A., Collier, T. J. & Wang, D. The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur. Heart J. 33, 176–182 (2012). An original article that proposes a statistical method for win ratio.
Heerspink, H. J. L. et al. Development and validation of a new hierarchical composite end point for clinical trials of kidney disease progression. J. Am. Soc. Nephrol. 34, 2025–2038 (2023). An original article that develops and validates a hierarchical composite endpoint for trials of kidney disease.
McMurray, J. J. V. et al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N. Engl. J. Med. 381, 1995–2008 (2019). An original article that presents the efficacy of dapagliflozin in patients with heart failure and reduced ejection fraction.
Solomon, S. D. et al. Dapagliflozin in heart failure with mildly reduced or preserved ejection fraction. N. Engl. J. Med. 387, 1089–1098 (2022). An original article that presents the efficacy of dapagliflozin in patients with heart failure and mildly reduced or preserved ejection fraction.
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This is a summary of: Kondo, T. et al. A hierarchical kidney outcome using win statistics in patients with heart failure from the DAPA-HF and DELIVER trials. Nat. Med. https://doi.org/10.1038/s41591-024-02941-8 (2024).
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The efficacy of dapagliflozin in a hierarchical kidney outcome in heart failure. Nat Med 30, 1253–1254 (2024). https://doi.org/10.1038/s41591-024-02974-z
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DOI: https://doi.org/10.1038/s41591-024-02974-z
