A hierarchical kidney outcome using win statistics in patients with heart failure from the DAPA-HF and DELIVER trials

Toru Kondo, Pardeep S. Jhund, Samvel B. Gasparyan, Mingming Yang, Brian L. Claggett, Finnian R. McCausland, Paolo Tolomeo, Muthiah Vadagunathan, Hiddo J.L. Heerspink, Scott D. Solomon, John J.V. McMurray*

*Corresponding author voor dit werk

OnderzoeksoutputAcademicpeer review

2 Citaten (Scopus)
53 Downloads (Pure)

Samenvatting

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.

Originele taal-2English
Pagina's (van-tot)1432–1439
Aantal pagina's23
TijdschriftNature Medicine
Volume30
Vroegere onlinedatum6-mei-2024
DOI's
StatusPublished - mei-2024

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