Dapagliflozin (Farxiga; AstraZeneca) demonstrated positive results in the phase 3 DAPA-CKD trial.
Treatment with dapagliflozin (Farxiga; AstraZeneca) reduced the risk of kidney failure and cardiovascular (CV) or renal death in patients with chronic kidney disease (CKD), according to results from a phase 3 clinical study.
The FDA approved dapagliflozin in May 2020 to reduce the risk of CV death and hospitalization for heart failure (hHF) in adults with heart failure and reduced ejection fraction, with and without type 2 diabetes. Dapagliflozin is also indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes and to reduce the risk of hHf in adults with type 2 diabetes and established CV disease or multiple CV risk factors.
In the phase 3 DAPA-CKD study, dapagliflozin significantly prolonged survival in patients with CKD with and without type 2 diabetes when added to standard of care. The study, which includes 4304 participants, was designed to evaluate the efficacy of dapagliflozin, 10 mg, compared with placebo in patients with CKD stages 2-4 and elevated urinary albumin excretion, with and without type 2 diabetes.
The primary composite end point of the study was ≥50% sustained decline in estimated glomerular filtration rate (eGFR), onset of end stage kidney disease (ESKD), and CV or renal death. According to the data, the absolute risk reduction (ARR) was 5.3% over the median time in the study of 2.4 years. The trial also met its secondary end points, including significantly reducing death from any cause by 31% (ARR=2.1%, p=0.0035) compared with placebo.
Dapagliflozin’s safety and tolerability in the study was consistent with its well-established safety profile. Patients treated with dapagliflozin in the study experienced fewer serious adverse events (AEs) compared with placebo (29.5% versus 33.9%, respectively).
“With [these] results, Farxiga becomes the first SGLT2 inhibitor proven to significantly prolong the survival of patients with chronic kidney disease with and without type 2 diabetes and we look forward to sharing these data with regulatory authorities around the world,” Mene Pangalos, executive vice president, BioPharmaceuticals R&D, said in a statement. Farxiga is also the first medicine in its class to demonstrate benefit in treating both heart failure and chronic kidney disease in patients with and without type 2 diabetes, and reduce the risk of hospitalization for heart failure and nephropathy in type 2 diabetes.”