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AstraZeneca announces positive results from Phase III DECLARE-TIMI 58

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Forxiga achieved a positive result in the Phase III DECLARE-TIMI 58 trial, a large cardiovascular outcomes trial in 17,000 patients with type-2 diabetes

AstraZeneca recently announced positive results from the Phase III DECLARE-TIMI 58 cardiovascular (CV) outcomes trial (CVOT) for Forxiga (dapagliflozin), the broadest SGLT2 inhibitor CVOT conducted to date. The trial evaluated the CV outcomes of Forxiga 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, Forxiga met its primary safety endpoint of non-inferiority for major adverse cardiovascular events (MACE). Forxiga achieved a statistically-significant reduction in the composite endpoint of hospitalisation for heart failure (hHF) or CV death, one of the two primary efficacy endpoints. Additionally, fewer MACE events were observed with Forxiga for the other primary efficacy endpoint, however, this did not reach statistical significance.

Data from DECLARE-TIMI 58 confirmed the well-established safety profile of Forxiga.

Elisabeth Björk, Vice President, Head of Cardiovascular, Renal and Metabolism, Global Medicines Development said, “Forxiga has achieved a statistically-significant and clinically-important reduction in hospitalisation 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 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 (TIMI) study group and co-principal investigator of the trial, commented, “The DECLARE-TIMI 58 results offer compelling evidence that dapagliflozin helps to address an important medical need among a diverse group of patients with type-2 diabetes by reducing the composite of hospitalisation for heart failure or CV death, with a safety profile supportive of broad use.”

Detailed trial results will be presented on November 10 at the American Heart Association Scientific Sessions 2018 in Chicago, USA.

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