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http://hdl.handle.net/2445/189959
Title: | Dapagliflozin in patients with chronic kidney disease |
Author: | Heerspink, Hiddo J.L. Stefánsson, Bergur V. Correa-Rotter, Ricardo Chertow, Glenn M. Greene, Tom Hou, Fan-Fan Mann, Johannes F.E. McMurray, John J.V. Lindberg, Magnus Rossing, Peter Sjöström, C. David Toto, Roberto D. Langkilde, Anna-Maria Wheeler, David C. Cruzado, Josep Ma. |
Keywords: | Malalties del ronyó Diabetis Glucòsids Kidney diseases Diabetes Glucosides |
Issue Date: | 24-Sep-2020 |
Publisher: | Massachusetts Medical Society |
Abstract: | 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. |
Note: | Reproducció del document publicat a: https://doi.org/10.1056/NEJMoa2024816 |
It is part of: | New England Journal of Medicine, 2020, vol. 383, num. 15, p. 1436-1446 |
URI: | http://hdl.handle.net/2445/189959 |
Related resource: | https://doi.org/10.1056/NEJMoa2024816 |
ISSN: | 0028-4793 |
Appears in Collections: | Articles publicats en revistes (Ciències Clíniques) |
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