AstraZeneca diabetes drug dapagliflozin shows significant benefits in CKD patients

The primary composite endpoint was ≥50% sustained decline in estimated glomerular filtration rate (eGFR), the onset of end-stage kidney disease (ESKD), and CV or renal death. The absolute risk reduction (ARR) was 5.3% over the median time in the study of 2.4 years. The trial also met all secondary endpoints, including significantly reducing death from any cause by 31% (ARR = 2.1%, p=0.0035) compared to placebo.

DAPA-CKD is the first trial to demonstrate efficacy, including improvement on survival, in CKD patients both with and without Type2 Diabetes.

Dr. Anil Kukreja, Vice President – Medical Affairs & Regulatory, AstraZeneca India said "AstraZeneca has always been on the forefront of an innovative solution for non-communicable diseases. Despite currently available therapies, a significant unmet need for effective management of CKD continues to exist globally. The DAPA-CKD trial which included 4,304 patients with CKD into a global study, with 201 patients from India. Now Dapa -CKD results goes on show that Dapagliflozin, which is already effective in Type 2 Diabetes, select Heart Failure patients has demonstrated significant efficacy now even in Chronic Kidney Disease. Dapagliflozin is the first SGLT2 inhibitor to demonstrate such unprecedented efficacy in the management of Chronic Kidney disease."

"Dr. Dinesh Khullar, the national lead investigator of Dapa-CKD in India, said "SGLT2 inhibitors of which dapagliflozin is a type have proved to be a very exciting and impressive class of drugs in the expanding armamentarium for our fight against diabetes. DAPA-CKD trial has shown an overwhelming advantage of the drug in slowing down the rate of progression of kidney disease in both diabetics as well as non diabetic patients."

In July 2020, Dapagliflozin was recently approved by USFDA as well as in India to reduce the risk of CV death and hospitalisation for heart failure (hHF) in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without T2D. Dapagliflozin is currently being assessed in patients with heart failure (HF) in the DELIVER (HF with preserved ejection fraction, HFpEF) and DETERMINE (HFrEF and HFpEF) trials, as well as in patients without T2D following an acute myocardial infarction (MI) or heart attack in the DAPA-MI trial – a first of its kind, indication-seeking registry-based randomised controlled trial.