Dapagliflozin (Forxiga) has been approved for use in the European Union to treat adults with chronic kidney disease who do not have diabetes. It is the first agent from the sodium-glucose cotransporter 2 inhibitor class to receive this designation in Europe. The approval follows the approval of the drug by the US Food and Drug Administration in April (in the United States, its brand name is Farxiga).
Until now, dapagliflozin had been approved in the European Union for glycemic control in patients with diabetes and for preventing death or serious complications in patients with heart failure with reduced ejection fraction, regardless of their diabetes status.
The approval is based on the results from the DAPA-CKD phase 3 trial, which included just over 4300 patients. Among those patients, the estimated glomerular filtration rate (eGFR) was 25–75 mL/min/1.73m2, and the urinary albumin-to-creatinine ratio was 200–5000. Patients were randomly assigned to receive dapagliflozin 10 mg daily or placebo on top of standard treatment. Roughly two thirds of patients enrolled in DAPA-CKD had type 2 diabetes.
The study was first presented at the European Society of Cardiology (ESC) Congress in 2020 and was later published in The New England Journal of Medicine. The results showed that treatment with dapagliflozin led to a 39% relative risk reduction in the incidence of a combined renal and cardiovascular endpoint during a median 2.4 years of follow-up, with an absolute risk reduction of 5.3%. The combined endpoint tallied the incidence of a 50% or greater drop in eGFR from baseline, onset of end-stage renal disease, or renal or cardiovascular death.
Dapagliflozin Delayed Dialysis and Reduced Number of Deaths
"We found that dapagliflozin delayed the initiation of dialysis and reduced the number of deaths" regardless of diabetes status, lead investigator Hiddo J. L. Heerspink, PhD, PharmD, from the University Medical Center Groningen, Groningen, the Netherlands, said during a press conference at the time of the presentation at the ESC Congress.
"The DAPA-CKD trial has shown dapagliflozin's potential as a long-awaited new treatment for patients with chronic kidney disease," he added.
DAPA-CKD was funded by AstraZeneca, the company that markets dapagliflozin. Heerspink has been a consultant to AstraZeneca and to numerous other companies.
Mitchel L. Zoler is a reporter with Medscape and MDedge based in the Philadelphia region. @mitchelzoler.
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Cite this: EU Approves Dapagliflozin for Kidney Disease, Regardless of Diabetes - Medscape - Aug 10, 2021.