Dapagliflozin (Farxiga; AstraZeneca) significantly reduced worsening of renal function or risk of death in patients with chronic kidney disease (CKD) with or without type 2 diabetes (T2D), according to high level results from the phase 3 DAPA-CKD-trial.
In March 2020, the DAPA-CKD trial was stopped early based on the recommendation from an Independent Data Monitoring Committee due to “overwhelming efficacy”. The multicenter, event-driven, double-blind, placebo-controlled trial compared the effect of dapagliflozin to placebo on renal outcomes and cardiovascular (CV) mortality in patients with CKD. Patients were randomized 1:1 to receive either dapagliflozin (5 mg or 10 mg) once daily or placebo in addition to standard of care.
The primary end point was a composite of worsening renal function or death (defined as a composite endpoint of ≥50% sustained decline in estimated glomerular filtration rate [eGFR], onset of end stage renal disease [ESRD] or CV or renal death) in patients with CKD irrespective of the presence of T2D. Secondary end points included time to first occurrence of the renal composite (sustained ≥50% eGFR decline, ESRD, and renal death), the composite of CV death or hospitalization for heart failure, and death from any cause. Findings showed the study met the primary composite end point and all secondary end points.
“DAPA-CKD is the first trial to demonstrate overwhelming efficacy, including improvement on survival, in chronic kidney disease patients both with and without type 2 diabetes,” said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca. “We look forward to sharing these exciting Farxiga results with the scientific community and health authorities worldwide.”
Farxiga, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, is currently approved as an adjunct to diet and exercise to improve glycemic control in adults with T2D. It is also indicated to reduce the risk of hospitalization for heart failure in patients with T2D and established CV disease or multiple CV risk factors; and to reduce the risk of CV death and hospitalization for heart failure in adults with heart failure (NYHA Class II-IV) with reduced ejection fraction.
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1. FARXIGA met all primary and secondary endpoints in groundbreaking phase III DAPA-CKD trial for the treatment of patients with chronic kidney disease. https://www.businesswire.com/news/home/20200728005496/en/FARXIGA-Met-Primary-Secondary-Endpoints-Groundbreaking-Phase. Published July 28, 2020. Accessed July 29, 2020.
This article originally appeared on MPR