FARXIGA DAPA-CKD Phase III Trial Reduced Worsening of Kidney Function, Risk of Cardiovascular or Renal Death in Patients With Chronic Kidney Disease Irrespective of Underlying Cause

A new subgroup analysis from the ground-breaking DAPA-CKD Phase III trial showed that AstraZeneca’s FARXIGA (dapagliflozin), on top of standard of care, reduced the composite of 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 the disease.¹

CKD is a serious, progressive condition defined by decreased kidney function. It is estimated it affects nearly 700 million people worldwide, many of them still undiagnosed.^2–5 The main causes of CKD are diabetes (38%), high blood pressure (26%), and glomerulonephritis (kidney inflammation, 16%).⁶

In the subgroup analysis, compared to placebo, FARXIGA showed a relative risk reduction (RRR) of 37% for patients whose CKD was primarily driven by diabetic kidney disease; (absolute risk reduction [ARR] = −5.8%), 25% for high blood pressure; (ARR = −2.2%), 57% for glomerulonephritis; (ARR = −7.5%), and 42% for CKD of other or unknown causes. (p−interaction for RRR 0.53). Similarly, FARXIGA showed a reduction in all-cause mortality, a secondary outcome, compared to placebo, regardless of underlying CKD cause (p-interaction 0.55).⁷

The safety and tolerability of FARXIGA was consistent with the well-established safety profile of the medicine.

Prof. Hiddo L. Heerspink, Co-chair of the DAPA-CKD trial and its Executive Committee, University Medical Center Groningen, the Netherlands, said: “These results reinforce the potential of FARXIGA to change the standard of care for a wide range of patients with chronic kidney disease, regardless of the root cause of their disease. This could open up enormous possibilities for the millions of patients living with chronic kidney disease worldwide.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “The DAPA-CKD trial showed the potential of FARXIGA as the first SGLT2 inhibitor to significantly prolong survival in a renal outcomes trial in patients with chronic kidney disease with and without type 2 diabetes. The new data presented further demonstrate FARXIGA’s consistent and clinically meaningful benefit across a diverse group of patients with chronic kidney disease, a population in urgent need of new treatment options to slow the progression of their disease.”