Farxiga Meets One Primary Endpoint in Large Ph III Cardiovascular Outcomes Trial in 17,000 Patients with Type 2 Diabetes

AstraZeneca on 9/24/18 announced positive results from the Phase III DECLARE-TIMI 58 cardiovascular (CV) outcomes trial (CVOT) for Farxiga (dapagliflozin), the broadest SGLT-2 inhibitor CVOT conducted to date. The trial evaluated the CV outcomes of Farxiga vs. placebo over a period of up to five years, across 33 countries and in more than 17,000 adults with type 2 diabetes (T2D) who have multiple CV risk factors or established CV disease.

In the DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58 trial, Farxiga met its primary safety endpoint of non-inferiority for major adverse cardiovascular events (MACE). Farxiga achieved a statistically-significant reduction in the composite endpoint of hospitalization for heart failure (hHF) or CV death, one of the two primary efficacy endpoints. Additionally, fewer MACE events were observed with Farxiga for the other primary efficacy endpoint, however, this did not reach statistical significance. Farxiga is not indicated to reduce the risk of CV events or hHF.

Elisabeth Björk, Vice President, Head of Cardiovascular, Renal and Metabolism, Global Medicines Development at AstraZeneca said: “Farxiga has achieved a statistically-significant and clinically-important reduction in hospitalization 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 hospitalizations that result in a considerable societal and economic burden.”

Farxiga is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Farxiga is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.