AstraZeneca has reported positive results from the Phase III DECLARE-TIMI 58 cardiovascular (CV) outcomes trial (CVOT) of Farxiga (dapagliflozin) against placebo for the treatment of patients with type 2 diabetes (T2D).
The trial met its primary safety objective of non-inferiority for major adverse cardiovascular events (MACE).
It also met one of its two primary composite objectives of a statistically significant reduction in hospitalisation for heart failure or CV death among the enrolled patients.
In addition, negligible numbers of MACE events were observed with Farxiga, however, this did not reach statistical significance.
The trial has also validated a well-established safety profile of Farxiga.
AstraZeneca vice-president and Global Medicines Development Cardiovascular, Renal and Metabolism head 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.”
The DECLARE-TIMI 58 trial was a randomised, double-blinded, placebo-controlled, multi-centre study that seeks to examine the effect of Farxiga in comparison with placebo on CV outcomes in adults with T2D who are at risk of CV events.
It was carried out for five years in more than 17,000 T2D patients who have multiple CV risk factors or established CV disease across 882 sites in 33 countries worldwide.
The trial was conducted in collaboration with academic investigators from the US’ TIMI study group and the Hadassah Hebrew University Medical Center in Jerusalem, Israel.
Farxiga is a new oral, once-daily selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2).