AstraZeneca says new data 'underpins' safety of Farxiga
AstraZeneca presented new data at the American Diabetes Association's Scientific Sessions underpinning the safety profile of Farxiga with an analysis of data pooled from dapagliflozin clinical trials, as well as three new cardiovascular 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 patients and seven patients identified in the dapagliflozin and control groups, respectively. Elisabeth Bjork, VP, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development, said: "SGLT-2 inhibitors are being prescribed with greater frequency for patients with type-2 diabetes, so it is vital that we have a clear understanding of the safety profile of these medicines and examine their effectiveness in a real-world setting. The data we are presenting at ADA underpins the safety of Farxiga and highlights the potential for earlier use of the SGLT-2 inhibitor class, and in broader patient populations than originally understood."