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Dapagliflozin in Patients with Chronic Kidney Disease

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  • Hiddo J L Heerspink
  • Bergur V Stefánsson
  • Ricardo Correa-Rotter
  • Glenn M Chertow
  • Tom Greene
  • Fan-Fan Hou
  • Johannes F E Mann
  • John J V McMurray
  • Magnus Lindberg
  • Peter Rossing
  • C David Sjöström
  • Roberto D Toto
  • Anna-Maria Langkilde
  • David C Wheeler
  • DAPA-CKD Trial Committees and Investigators
  • Mads Hornum (Medlem af forfattergruppering)
  • Ditte Hansen (Medlem af forfattergruppering)
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BACKGROUND: Patients with chronic kidney disease have a high risk of adverse kidney and cardiovascular outcomes. The effect of dapagliflozin in patients with chronic kidney disease, with or without type 2 diabetes, is not known.

METHODS: We randomly assigned 4304 participants with an estimated glomerular filtration rate (GFR) of 25 to 75 ml per minute per 1.73 m2 of body-surface area and a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 200 to 5000 to receive dapagliflozin (10 mg once daily) or placebo. The primary outcome was a composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes.

RESULTS: The independent data monitoring committee recommended stopping the trial because of efficacy. Over a median of 2.4 years, a primary outcome event occurred in 197 of 2152 participants (9.2%) in the dapagliflozin group and 312 of 2152 participants (14.5%) in the placebo group (hazard ratio, 0.61; 95% confidence interval [CI], 0.51 to 0.72; P<0.001; number needed to treat to prevent one primary outcome event, 19 [95% CI, 15 to 27]). The hazard ratio for the composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal causes was 0.56 (95% CI, 0.45 to 0.68; P<0.001), and the hazard ratio for the composite of death from cardiovascular causes or hospitalization for heart failure was 0.71 (95% CI, 0.55 to 0.92; P = 0.009). Death occurred in 101 participants (4.7%) in the dapagliflozin group and 146 participants (6.8%) in the placebo group (hazard ratio, 0.69; 95% CI, 0.53 to 0.88; P = 0.004). The effects of dapagliflozin were similar in participants with type 2 diabetes and in those without type 2 diabetes. The known safety profile of dapagliflozin was confirmed.

CONCLUSIONS: Among patients with chronic kidney disease, regardless of the presence or absence of diabetes, the risk of a composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes was significantly lower with dapagliflozin than with placebo. (Funded by AstraZeneca; DAPA-CKD ClinicalTrials.gov number, NCT03036150.).

OriginalsprogEngelsk
TidsskriftThe New England journal of medicine
Vol/bind383
Udgave nummer15
Sider (fra-til)1436-1446
Antal sider11
ISSN0028-4793
DOI
StatusUdgivet - 8 okt. 2020

Bibliografisk note

Copyright © 2020 Massachusetts Medical Society.

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