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A pre-specified analysis of the Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) randomized controlled trial on the incidence of abrupt declines in kidney function

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  • Hiddo Jl Heerspink
  • David Cherney
  • Douwe Postmus
  • Bergur V Stefánsson
  • Glenn M Chertow
  • Jamie P Dwyer
  • Tom Greene
  • Mikhail Kosiborod
  • Anna Maria Langkilde
  • John Jv McMurray
  • Ricardo Correa-Rotter
  • Peter Rossing
  • C David Sjöström
  • Robert D Toto
  • David C Wheeler
  • DAPA-CKD Trial Committees and Investigators
  • Mads Hornum (Member of study group)
  • Ulrik Pedersen-Bjergaard (Member of study group)
  • Ditte Hansen (Member of study group)
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This pre-specified analysis of DAPA-CKD assessed the impact of sodium-glucose cotransporter 2 inhibition on abrupt declines in kidney function in high-risk patients based on having chronic kidney disease (CKD) and substantial albuminuria. DAPA-CKD was a randomized, double-blind, placebo-controlled trial that had a median follow-up of 2.4 years. Adults with CKD (urinary albumin-to-creatinine ratio 200-5000 mg/g and estimated glomerular filtration rate 25-75 mL/min/1.73m2) were randomized to dapagliflozin 10 mg/day matched to placebo (2152 individuals each). An abrupt decline in kidney function was defined as a pre-specified endpoint of doubling of serum creatinine between two subsequent study visits. We also assessed a post-hoc analysis of investigator-reported acute kidney injury-related serious adverse events. Doubling of serum creatinine between two subsequent visits (median time-interval 100 days) occurred in 63 (2.9%) and 91 (4.2%) participants in the dapagliflozin and placebo groups, respectively (hazard ratio 0.68 [95% confidence interval 0.49, 0.94]). Accounting for the competing risk of mortality did not alter our findings. There was no heterogeneity in the effect of dapagliflozin on abrupt declines in kidney function based on baseline subgroups. Acute kidney injury-related serious adverse events were not significantly different and occurred in 52 (2.5%) and 69 (3.2%) participants in the dapagliflozin and placebo groups, respectively (0.77 [0.54, 1.10]). Thus, in patients with CKD and substantial albuminuria, dapagliflozin reduced the risk of abrupt declines in kidney function.

Original languageEnglish
JournalKidney International
Volume101
Issue number1
Pages (from-to)174-184
Number of pages11
ISSN0085-2538
DOIs
Publication statusPublished - Jan 2022

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Copyright © 2021. Published by Elsevier Inc.

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