201. Dapagliflozin in Patients with Chronic Kidney Disease
- Author
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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., Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET), and Groningen Kidney Center (GKC)
- Subjects
Male ,Kidney Failure, Chronic/mortality ,Benzhydryl Compounds/adverse effects ,Kaplan-Meier Estimate ,030204 cardiovascular system & hematology ,Glomerular Filtration Rate/drug effects ,law.invention ,chemistry.chemical_compound ,0302 clinical medicine ,Randomized controlled trial ,Glucosides ,law ,Diabetic Nephropathies ,030212 general & internal medicine ,Dapagliflozin ,Kidney ,Diabetis ,Kidney diseases ,Diabetes ,EMPAGLIFLOZIN ,General Medicine ,Middle Aged ,medicine.anatomical_structure ,Cardiovascular Diseases ,Regression Analysis ,Female ,Glomerular Filtration Rate ,medicine.medical_specialty ,Finerenone ,Renal Insufficiency, Chronic/complications ,CARDIOVASCULAR OUTCOMES ,Glucosides/adverse effects ,03 medical and health sciences ,Internal medicine ,Diabetes mellitus ,Empagliflozin ,medicine ,Humans ,Benzhydryl compounds ,Cardiovascular Diseases/etiology ,Benzhydryl Compounds ,Renal Insufficiency, Chronic ,Sodium-Glucose Transporter 2 Inhibitors ,Aged ,urogenital system ,business.industry ,Diabetes Mellitus, Type 2/complications ,Glucòsids ,Sodium-Glucose Transporter 2 Inhibitors/adverse effects ,medicine.disease ,Diabetes Mellitus, Type 2 ,chemistry ,Diabetic Nephropathies/drug therapy ,Kidney Failure, Chronic ,Malalties del ronyó ,business ,Kidney disease - Abstract
Background: \ud 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.\ud Methods: \ud 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.\ud Results:\ud 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
- Published
- 2020