DAPA-CKD RESULTS ANNOUNCED
DAPA-CKD is an international, multi-centre, randomised, double-blinded trial in 4,245 patients designed to evaluate the efficacy of Dapagliflozin 10mg, compared with placebo, in patients with CKD stages 2–4 and elevated urinary albumin excretion, with and without T2D.
DAPA-CKD trial showed a statistically significant and clinically meaningful effect on its primary endpoint of a composite of worsening of renal function or risk of death (defined as a composite endpoint of ≥50% sustained decline in estimated glomerular filtration rate (eGFR), onset of end stage kidney disease (ESKD) or cardiovascular (CV) or renal death) in adult patients with chronic kidney disease (CKD). The trial also met all its secondary endpoints in CKD patients with and without type-2 diabetes (T2D), making Forxiga the first medicine to significantly reduce the risk of death from any cause in this patient population.
The Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) Phase III trial for dapagliflozin in patients with chronic kidney disease (CKD) will be stopped early following a recommendation from an independent Data Monitoring Committee (DMC) based on its determination of overwhelming efficacy.
Full results of DAPA-CKD will be presented during Kidney Week, the annual meeting of the American Society of Nephrology, set for October 20-25, 2020.
FDA removes canagliflozin boxed warning
Based on review of new data from three clinical trials, FDA has removed the Boxed Warning about amputation risk from the diabetes medicine canagliflozin. The warning was removed by FDA after reviewing data from 3 new clinical trials. The FDA stated that the risk of amputation is lower than previously described when monitored appropriately.
Canagliflozin was approved in 2018 to reduce the risk of major heart-related events in patients with type 2 diabetes who have known heart disease. In 2019, the drug was approved to reduce the risk of end-stage kidney disease, worsening of kidney function, heart-related death, and being hospitalized for heart failure in certain patients with type 2 diabetes and diabetic kidney disease.