Phase III DECLARE-TIMI 58 results for Farxiga show reduced risk of hospitalisation from CV events.- AstraZeneca.

AstraZeneca announced positive full results from the DECLARE-TIMI 58 cardiovascular (CV) outcomes trial (CVOT) for Farxiga (dapagliflozin) which showed that Farxiga significantly reduced the risk of hospitalization for heart failure (hHF) or CV death composite vs. placebo by 17% (4.9% vs. 5.8%), one of the two primary efficacy endpoints. The reduction in hHF or CV death was consistent across the entire patient population, which included those with CV risk factors and those with established CV disease. Farxiga is not indicated to reduce the risk of CV events or hHF.

Additionally, there were fewer major adverse cardiovascular events (MACE) observed with Farxiga for the other primary efficacy endpoint, however this did not reach statistical significance (8.8% for Farxiga vs. 9.4% for placebo; HR 0.93. DECLARE-TIMI 58 also confirmed the well-established safety profile for Farxiga, which met the primary safety endpoint of non-inferiority vs. placebo, demonstrating no increase in the composite of MACE, defined as CV death, heart attack (myocardial infarction), or stroke. Further, on other relevant safety measures, the trial showed no imbalance with Farxiga vs. placebo in amputations (1.4% vs. 1.3%), fractures (5.3% vs. 5.1%), bladder cancer (0.3% vs. 0.5%) or Fournier�s gangrene (1 case vs. 5 cases). The respective incidences of diabetic ketoacidosis (0.3% vs. 0.1%) and genital infections (0.9% vs. 0.1%) were rare.

The data were presented as a late-breaking abstract (#19485) at the American Heart Association (AHA) Scientific Sessions 2018 in Chicago, IL, and simultaneously published in the New England Journal of Medicine (NEJM).

See: "Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes." Wiviott SD, et al. New England Journal of Medicine. 2018 Nov. DOI: 10.1056/NEJMoa181289