Detailed results from the ground-breaking Phase III DAPA-CKD trial showed that AstraZeneca’s Dapagliflozin on top of standard of care reduced the composite measure of worsening of renal function or risk of cardiovascular (CV) or renal death by 39 percen compared to placebo in patients with chronic kidney disease (CKD) Stages 2-4 and elevated urinary albumin excretion.
One of the investigators in the Philippines, Dr. Romina Danguilan said that “the long-awaited results of the DAPA CKD study bring to light Dapagliflozin as a new and effective treatment for chronic kidney disease that would save more patient lives.” CKD is a serious, progressive condition defined by decreased kidney function affecting nearly 700 million people worldwide, many of them still undiagnosed, and the most common causes are diabetes, hypertension and glomerulonephritis.
The results were consistent in patients both with and without type-2 diabetes (T2D).
Dapagliflozin is the 1st and only diabetes medication under the class of SGLT2 inhibitors to meet all primary and secondary endpoints including death from any cause by 31 percent compared to placebo. A 34 percent relative risk reduction is seen in the exploratory composite outcome of chronic dialysis, kidney transplantation or renal death.
The safety and tolerability of Dapagliflozin were consistent with its well-established safety profile. In the trial, patients treated with Dapagliflozin experienced fewer serious adverse events compared to placebo.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “With the trial’s results, Dapagliflozin 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.
Dapagliflozin 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.” In the Philippines, Dapagliflozin is currently indicated only as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.