Ongoing CVD-REAL trial of Farxiga (dapagliflozin) shows no new safety signals in type 2 diabetes- AstraZeneca

AstraZeneca presented new data underpinning the safety profile of Farxiga (dapagliflozin) with an analysis of data pooled from dapagliflozin clinical trials, as well as three new cardiovascular (CV) outcomes analyses from the ongoing CVD-REAL study, the first large real-world evidence study of its kind evaluating treatment with SGLT-2 inhibitors, including dapagliflozin. In an updated safety analysis, data pooled from 30 Phase IIb/III clinical trials for dapagliflozin showed no new safety signals and the incidence of adverse events was generally similar to that in the control groups. Importantly, there was no imbalance in lower-limb amputations, with eight (0.1%) patients and seven (0.2%) patients identified in the dapagliflozin and control groups, respectively.

A two-country analysis of more than 30,000 patients with T2D showed a significant reduction in the rates of hospitalisation for kidney disease by 62%, hospitalisation for heart failure (HF) by 37% and death from any cause by 27% for patients using dapagliflozin versus DPP-4 inhibitors. In addition, a three-country analysis of nearly 100,000 patients with T2D showed a significant reduction in rates of CV death by 47% and hospitalisation for HF by 30%, for patients new to SGLT-2 versus other T2D medicines. Data were presented at the American Diabetes Association’s (ADA) 77th Scientific Sessions.