AstraZeneca reveals positive results from Farxiga cardiovascular trial
AstraZeneca announced positive results from the phase III DECLARE-TIMI 58 cardiovascular outcomes trial for ‘Farxiga’ dapagliflozin, which it said was the broadest SGLT2 inhibitor cardiovascular outcome trial conducted to date.
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The FTSE 100 drugmaker said the trial evaluated the cardiovascular outcomes of Farxiga against placebo over a period of up to five years, across 33 countries and in more than 17,000 adults with type-2 diabetes who had multiple cardiovascular risk factors, or established cardiovascular disease.
In the trial, Farxiga met its primary safety endpoint of non-inferiority for major adverse cardiovascular events.
Farxiga achieved a “statistically-significant reduction” in the composite endpoint of hospitalisation for heart failure or cardiovascular death - one of the two primary efficacy endpoints.
Additionally, fewer major adverse cardiovascular events were observed with Farxiga for the other primary efficacy endpoint, although AstraZeneca said that did not reach statistical significance.
Data from DECLARE-TIMI 58 confirmed the well-established safety profile of Farxiga, the company said.
“Farxiga has achieved a statistically-significant and clinically-important reduction in hospitalisation for heart failure or cardiovascular death in a broad range of patients with type-2 diabetes and cardiovascular risk,” said head of cardiovascular, renal and metabolism at AstraZeneca Global Medicines Development, Elisabeth Björk.
“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.”
Dr Stephen Wiviott of Brigham and Women's Hospital and Harvard Medical School, a senior investigator with the thrombolysis in myocardial infarction study group and co-principal investigator of the trial, added that the results offered “compelling evidence” that dapagliflozin helps to address an important medical need among a diverse group of patients with type-2 diabetes.
“[It did this by] reducing the composite of hospitalisation for heart failure or CV death, with a safety profile supportive of broad use,” Dr Wiviott said.
Detailed trial results would be presented on 10 November at the American Heart Association Scientific Sessions 2018 in Chicago.