Jennifer Barrett is the senior editor for Drug Topics® and Total Pharmacy®.
A subgroup analysis of the DAPA-CKD phase 3 trial reported on the continued benefit of dapagliflozin in patients with chronic kidney disease, regardless of underlying cause.
AstraZeneca’s dapagliflozin (Farxiga) reduced worsening of kidney function or risk of cardiovascular (CV) or renal death in patients with chronic kidney disease (CKD), irrespective of the underlying cause of disease, according to results of a new subgroup analysis of the DAPA-CKD phase 3 trial.
Earlier this month, officials with the FDA granted Breakthrough Therapy Designation to dapagliflozin for patients with CKD, with and without type 2 diabetes. Dapagliflozin is a first-in-class, oral, once-daily sodium glucose co-transporter-2 inhibitor indicated in adults for the treatment of insufficiently controlled type 2 diabetes as monotherapy and as part of combination therapy as an adjunct to diet and exercise to improve glycemic control, with additional benefits of weight loss and blood pressure reduction.
As part of the international, multi-center, randomized, double-blinded DAPA-CKD trial program, the efficacy and safety of dapagliflozin is being evaluated in 4304 patients with CKD stages 2-4 and elevated urinary albumin excretion, with and without type 2 diabetes. Previous findings showed that dapagliflozin 10 mg reduced the primary composite end point of worsening renal function or renal or CV death by 39% compared with placebo.
This subgroup analysis reinforced these findings and demonstrated that this benefit can be achieved irrespective of underlying cause of the disease. The data were presented at the American Society of Nephrology (ASN) Kidney Week Reimagined 2020.
In patients treated with dapagliflozin compared with placebo, investigators reported a relative risk reduction (RRR) of 37% for patients whose CKD was primarily driven by diabetic kidney disease, 25% for high blood pressure, 57% for glomerulonephritis, and 42% for CKD of other or unknown causes. Dapagliflozin also showed a reduction in all-cause mortality compared with placebo regardless of underlying CKD cause.
The safety and tolerability of dapagliflozin was consistent with the well-established safety profile of the medicine.
“These results reinforce the potential of dapagliflozin to change the standard of care for a wide range of patients with chronic kidney disease, regardless of the root cause of the disease,” Hiddo L. Heerspink, co-chair of the DAPA-CKD trial and its executive committee, University Medical Center Groningen, the Netherlands, said in a statement. “This could open up enormous possibilities for the millions of patients living with chronic kidney disease worldwide.”