AstraZeneca announced positive results from DECLARE-TIMI 58 outcomes rial
AstraZeneca announced positive full results from the DECLARE-TIMI 58 cardiovascular outcomes trial for FARXIGA. The data were presented as a late-breaking abstract at the American Heart Association Scientific Sessions 2018 in Chicago, IL, and simultaneously published in the New England Journal of Medicine. Results from DECLARE-TIMI 58, the largest SGLT-2 inhibitor CVOT conducted to date, including more than 17,000 patients across 33 countries, showed that FARXIGA significantly reduced the risk of hospitalization for heart failure or CV death composite vs. placebo by 17%, 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 observed with FARXIGA for the other primary efficacy endpoint, however this did not reach statistical significance. DECLARE-TIMI 58 also confirmed the well-established safety profile for FARXIGA, which met the primary safety endpoint of non-inferiority versus placebo, demonstrating no increase in the composite of MACE, defined as CV death, heart attack, or stroke. Further, on other relevant safety measures, the trial showed no imbalance with FARXIGA versus placebo in amputations, fractures, bladder cancer or Fournier's gangrene. The respective incidences of diabetic ketoacidosis and genital infections were rare. Although secondary endpoints were only nominally significant, the renal composite endpoint showed that FARXIGA reduced the rate of new or worsening nephropathy by 24% vs. placebo across the broad patient population studied, and there were fewer all-cause mortality events with FARXIGA vs. placebo. FARXIGA is not indicated to reduce the risk of HF, other CV outcomes, nephropathy or all-cause mortality.