July 28, 2020 — AstraZeneca's heart failure medication dapagliflozin (Farxiga) significantly reduced the worsening of renal function or risk of death in patients with chronic kidney disease with and without type 2 diabetes in the Phase III DAPA-CKD trial results. This trial was among the American College of Cardiology (ACC) 2020 late-breaking studies.
The data show a statistically significant and clinically meaningful effect on its primary endpoint of a composite of worsening of renal function or risk of death (defined as a composite endpoint of ≥50% sustained decline in estimated glomerular filtration rate (eGFR), onset of end stage kidney disease (ESKD) or cardiovascular (CV) or renal death in adult patients with chronic kidney disease (CKD). The trial also met all its secondary endpoints in CKD patients with and without type 2 diabetes (T2D), making dapagliflozin the first medicine to significantly reduce the risk of death from any cause in this patient population.
CKD is a serious, progressive condition defined by decreased kidney function affecting nearly 700 million people worldwide, many of them still undiagnosed. Currently there are limited treatment options for these patients. CKD is associated with significant patient morbidity and an increased risk of CV events, such as heart failure (HF) and premature death.
“The DAPA-CKD trial has shown dapagliflozin’s potential as a long-awaited new treatment option for patients with chronic kidney disease. The data will be transformative for these patients,” wrote the co-chairs of the trial, Prof. David Wheeler, University College London, and Prof. Hiddo L. Heerspink, University Medical Center Groningen.
The safety and tolerability profile for dapagliflozin was consistent with the well-established safety profile of the medicine.
The full DAPA-CKD trial results will be submitted for presentation at a forthcoming medical meeting.
In March 2020, AstraZeneca announced that the DAPA-CKD trial was being stopped early following a recommendation from an independent Data Monitoring Committee based on its determination of overwhelming efficacy.
Additionally, in May 2020, dapagliflozin was approved in the U.S. to reduce the risk of CV death and hospitalization for heart failure (hHF) in adults with HF (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without T2D. Dapagliflozin is also under review with the European Medicines Agency (EMA), as well as in other regions, for the treatment of patients with HF.
Dapagliflozin is also indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D, and in the U.S. it is approved to reduce the risk of hospitalization for HF in adults with T2D and established CV disease or multiple CV risk factors. Dapagliflozin is not indicated to reduce the worsening of renal function or death in patients with CKD.
For more information: www.farxiga.com
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Dapagliflozin Reduces Heart Failure Worsening and Death in DAPA-HF Sub-analysis — ACC 2020 late-breaking study