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Heerspink, Hiddo J L; Stefansson, Bergur V; Chertow, Glenn M; Correa-Rotter, Ricardo; Greene, Tom; Hou, Fan-Fan; Lindberg, Magnus; McMurray, John; Rossing, Peter; Toto, Roberto; Langkilde, Anna Maria; Wheeler, David C; Heerspink, H J L; Wheeler, D C; Chertow, G; Correa-Rotter, R; Greene, T; Hou, F-F; McMurray, J; Rossing, P; Toto, R; Stefansson, B; Langkilde, A M; Pfeffer, Marc A; [...]

Rationale and protocol of the Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) randomized controlled trial

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  • Medientyp: E-Artikel
  • Titel: Rationale and protocol of the Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) randomized controlled trial
  • Beteiligte: Heerspink, Hiddo J L; Stefansson, Bergur V; Chertow, Glenn M; Correa-Rotter, Ricardo; Greene, Tom; Hou, Fan-Fan; Lindberg, Magnus; McMurray, John; Rossing, Peter; Toto, Roberto; Langkilde, Anna Maria; Wheeler, David C; Heerspink, H J L; Wheeler, D C; Chertow, G; Correa-Rotter, R; Greene, T; Hou, F-F; McMurray, J; Rossing, P; Toto, R; Stefansson, B; Langkilde, A M; Pfeffer, Marc A; [...]
  • Erschienen: Oxford University Press (OUP), 2020
  • Erschienen in: Nephrology Dialysis Transplantation, 35 (2020) 2, Seite 274-282
  • Sprache: Englisch
  • DOI: 10.1093/ndt/gfz290
  • ISSN: 0931-0509; 1460-2385
  • Entstehung:
  • Hochschulschrift:
  • Anmerkungen:
  • Beschreibung: <jats:title>Abstract</jats:title> <jats:sec> <jats:title>Background</jats:title> <jats:p>Recent cardiovascular outcome trials have shown that sodium–glucose co-transporter 2 (SGLT2) inhibitors slow the progression of chronic kidney disease (CKD) in patients with type 2 diabetes at high cardiovascular risk. Whether these benefits extend to CKD patients without type 2 diabetes or cardiovascular disease is unknown. The Dapagliflozin and Prevention of Adverse Outcomes in CKD (DAPA-CKD) trial (NCT03036150) will assess the effect of the SGLT2 inhibitor dapagliflozin on renal and cardiovascular events in a broad range of patients with CKD with and without diabetes.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>DAPA-CKD is a randomized, double-blind, placebo-controlled, trial in which ∼4300 patients with CKD Stages 2–4 and elevated urinary albumin excretion will be enrolled. The vast majority will be receiving a maximum tolerated dose of a renin–angiotensin system inhibitor at enrolment.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>After a screening assessment, eligible patients with a urinary albumin:creatinine ratio ≥200 mg/g and estimated glomerular filtration rate (eGFR) between 25 and 75 mL/min/1.73 m2 are randomly assigned to placebo or dapagliflozin 10 mg/day. Enrolment is monitored to ensure that at least 30% of patients do not have diabetes and that no more than 10% have an eGFR &amp;gt;60 mL/min/1.73 m2. The primary endpoint is a composite of a sustained decline in eGFR of ≥50%, end-stage renal disease, renal death or cardiovascular death. The trial will conclude when 681 primary renal events have occurred, providing 90% power to detect a 22% relative risk reduction (α level of 0.05).</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusion</jats:title> <jats:p>DAPA-CKD will determine whether the SGLT2 inhibitor dapagliflozin, added to guideline-recommended therapies, safely reduces the rate of renal and cardiovascular events in patients across multiple CKD stages with and without diabetes.</jats:p> </jats:sec>
  • Zugangsstatus: Freier Zugang