Positive results from the Phase III DECLARE-TIMI 58 trial for AZ

AstraZeneca has received good news from the Phase III DECLARE-TIMI 58 trial for Farxiga (dapagliflozin) which involved over 17,000 adults in 33 countries with type-2 diabetes and cardiovascular disease, or multiple cardiovascular risk factors.
The trial compared Farxiga with placebo over 5 years and the AZ drug achieved a statistically-significant reduction in hospitalisation for heart failure or cardiovascular death. It met its primary safety endpoint of non-inferiority for major adverse cardiovascular events, and there were fewer major adverse cardiovascular events observed, confirming the safety profile of Farxiga.
Vice President, Head of Cardiovascular, Renal and Metabolism, Global Medicines Development, Elisabeth Björk, said: “Farxiga has achieved a statistically-significant and clinically-important reduction in hospitalisation for heart failure or CV death in a broad range of patients with type-2 diabetes and cardiovascular risk. The results from this landmark trial are especially important since heart failure is an early and frequent complication of diabetes and associated with hospitalisations that result in a considerable societal and economic burden.”
A senior investigator with the Thrombolysis in Myocardial Infarction (TIMI) study group and co-principal investigator of the trial, Dr Stephen Wiviott, said: “The DECLARE-TIMI 58 results offer compelling evidence that dapagliflozin helps to address an important medical need among a diverse group of patients with type-2 diabetes by reducing the composite of hospitalisation for heart failure or CV death, with a safety profile supportive of broad use.”