AstraZeneca Plc (LSE:AZ), a global, science-led biopharmaceutical company, announced on Monday 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.
This trial evaluated the CV outcomes of Farxiga versus 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.
Reportedly, 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. Also, fewer MACE events were observed with Farxiga for the other primary efficacy endpoint, however, this did not reach statistical significance.
According to the company, data from DECLARE-TIMI 58 confirmed the well-established safety profile of Farxiga. It added that detailed trial results will be presented on 10 November 2018 at the American Heart Association Scientific Sessions 2018 in Chicago, US.
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 across a spectrum of people with CV risk factors, established CV disease and varying stages of renal disease, both with and without T2D. DECLARE is paving the way for three phase III trials, namely Dapa-HF, DELIVER and Dapa-CKD.
AstraZeneca focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory.
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