AstraZeneca India announced the full results from the clinical trials of its latest diabetes drug, dapagliflozin, showing significant benefits in reducing chronic kidney disease (CKD) progression in patients with and without type-2 diabetes. The DAPA-CKD study concluded globally on March 30, 2020.
Detailed results from the 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 per cent compared to placebo (p<0.0001) in patients with chronic kidney disease (CKD) Stages 2-4 and elevated urinary albumin excretion. The results were consistent in patients both with and without type-2 diabetes (T2D). 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 primary composite endpoint was ≥50 per cent sustained decline in estimated glomerular filtration rate (eGFR), onset of end-stage kidney disease (ESKD) and CV or renal death. The absolute risk reduction (ARR) was 5.3 per cent 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 per cent (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 “Despite currently available therapies, a significant unmet need for effective management of CKD continues to exist globally. The DAPA-CKD trial included 4,304 patients with CKD into a global study, with 201 patients from India. Now Dapa -CKD results goes on to 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, 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.”
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. It 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.