GHP Q4 2018

22 GHP / Q4 2018 , Farxigamet the primary composite endpoint of a statistically-significant reduction in hospitalisation for heart failure or CV death in a broad patient population. Results confirmed the well-established safety profile of Farxiga. Farxiga 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 On the 24th September, AstraZeneca announced positive results from the Phase III DECLARE-TIMI 58 cardiovascular (CV) outcomes trial (CVOT) for Farxiga (dapagliflozin), the broadest SGLT2 inhibitor CVOT conducted to date. The trial evaluated the CV outcomes of Farxiga 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, Farxiga met its primary safety endpoint of non-inferiority for major adverse cardiovascular events (MACE). Farxiga 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 Farxiga 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 Farxiga. Elisabeth Björk, Vice President, Head of Cardiovascular, Renal and Metabolism, Global Medicines Development said: “Farxiga 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 10 November at the American Heart Association Scientific Sessions 2018 in Chicago, USA. About DECLARE-TIMI 58 DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58 is an AstraZeneca-sponsored, randomised, double-blinded, placebo-controlled, multicentre trial designed to evaluate the effect of Farxiga compared with placebo on CV outcomes in adults with T2D at risk of CV events, including patients with multiple CV risk factors or established CV disease. DECLARE included more than 17,000 patients across 882 sites in 33 countries and was independently run in collaboration with academic investigators from the TIMI study group (Boston, USA) and the Hadassah Hebrew University Medical Center (Jerusalem, Israel).8 DECLARE is part of the extensive DapaCare clinical programme for Farxiga, which will enrol patients in randomised clinical trials, including a wide range of mechanistic studies, and is supported by a multinational real-world evidence study (CVD- REAL). The DapaCare clinical programme will generate data