McMurray, J. (2024) A hierarchical kidney outcome using win statistics in patients with heart failure from the DAPA-HF and DELIVER trials. Nature Medicine, (doi: 10.1038/s41591-024-02941-8) (Early Online Publication)
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Abstract
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.
Item Type: | Articles |
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Additional Information: | P.S.J. and J.J.V.M. are supported by a British Heart Foundation Centre of Research Excellence grant no. RE/18/6/34217 and the Vera Melrose Heart Failure Research Fund. T.K. is supported by grant no. 20K17112 from Grant-in-Aid for Scientific Research. DAPA-HF and DELIVER were funded by AstraZeneca; however, the analyses and writing of the manuscript were conducted independently at the University of Glasgow. |
Status: | Early Online Publication |
Refereed: | Yes |
Glasgow Author(s) Enlighten ID: | McMurray, Professor John |
Authors: | McMurray, J. |
College/School: | College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health |
Journal Name: | Nature Medicine |
Publisher: | Nature Research |
ISSN: | 1078-8956 |
ISSN (Online): | 1546-170X |
Published Online: | 06 May 2024 |
Copyright Holders: | Copyright © the author(s) 2024 |
First Published: | First published in Nature Medicine 2024 |
Publisher Policy: | Reproduced under a Creative Commons license |
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