Journal article
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
Kidney international, Vol.101(1), pp.174-184
01/2022
DOI: 10.1016/j.kint.2021.09.005
PMID: 34560136
Abstract
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/1.73m
) 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.
Details
- Title: Subtitle
- 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
- Creators
- Hiddo J L Heerspink - University of GroningenDavid Cherney - University of TorontoDouwe Postmus - University of GroningenBergur V Stefánsson - Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D AstraZeneca Gothenburg SwedenGlenn M Chertow - Stanford UniversityJamie P Dwyer - Vanderbilt University Medical CenterTom Greene - University of UtahMikhail Kosiborod - University of Missouri–Kansas CityAnna Maria Langkilde - Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D AstraZeneca Gothenburg SwedenJohn J V McMurray - University of GlasgowRicardo Correa-Rotter - The National Medical Science and Nutrition Institute Salvador Zubiran, Mexico City, Mexico.Peter Rossing - Steno Diabetes CentersC David Sjöström - Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D AstraZeneca Gothenburg SwedenRobert D Toto - The University of Texas Southwestern Medical CenterDavid C Wheeler - The George Institute for Global HealthDAPA-CKD Trial Committees and Investigators
- Contributors
- D Jalal (Contributor) - University of Iowa, Internal Medicine
- Resource Type
- Journal article
- Publication Details
- Kidney international, Vol.101(1), pp.174-184
- DOI
- 10.1016/j.kint.2021.09.005
- PMID
- 34560136
- NLM abbreviation
- Kidney Int
- ISSN
- 0085-2538
- eISSN
- 1523-1755
- Language
- English
- Date published
- 01/2022
- Academic Unit
- Nephrology; Internal Medicine
- Record Identifier
- 9984359766202771
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