AstraZeneca posts positive results from recent Farxiga trial
By Josh White
Date: Monday 12 Nov 2018
(Sharecast News) - AstraZeneca announced positive full results from the DECLARE-TIMI 58 cardiovascular outcomes trial for Farxiga (dapagliflozin) on Monday.
The FTSE 100 pharmaceutical giant said the data was presented as a late-breaking abstract at the American Heart Association Scientific Sessions 2018 in Chicago, and simultaneously published in the New England Journal of Medicine.
It aid results from DECLARE-TIMI 58, the largest SGLT2 inhibitor CVOT conducted to date, including more than 17,000 patients across 33 countries, showed that Farxiga "significantly reduced" the risk of hospitalisation for heart failure or cardiovascular death composite compared placebo by 17% - one of the two primary efficacy endpoints.
The reduction in hHF or cardiovascular death was said to have been consistent across the entire patient population, which included those with cardiovascular risk factors and those with established cardiovascular disease.
Additionally, there were said to have been fewer major adverse cardiovascular events observed with Farxiga for the other primary efficacy endpoint, although that 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 compared to placebo, demonstrating no increase in the composite of major adverse cardiovascular events, defined as cardiovascular death, heart attack, or stroke.
Further, on other relevant safety measures, the trial reportedly showed no imbalance with Farxiga compared to placebo in amputations, fractures, bladder cancer, or Fournier's gangrene.
The respective incidences of diabetic ketoacidosis and genital infections were described as "rare".
"These positive results are clinically relevant to the 425 million people worldwide living with diabetes, of whom those with type-2 diabetes have a two-to-five times greater risk of heart failure along with an increased risk of a heart attack or stroke," said AstraZeneca's head of cardiovascular, renal and metabolism at its Global Medicines Development arm, Elisabeth Björk.
"Heart failure survival rates are only 50% after five years from diagnosis, which is why these new findings are so important in broadening our understanding of how to go beyond blood glucose so we may better address this serious and often overlooked cardiovascular complication."
AstraZeneca said that, although secondary endpoints were only "nominally significant", the renal composite endpoint showed that Farxiga reduced the rate of new or worsening nephropathy by 24% compared to placebo across the broad patient population studied, and there were fewer all-cause mortality events with Farxiga compared to placebo.
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