NOTES TO EDITORS
About Dapagliflozin (Farxiga) Clinical Trials Programme
Dapagliflozin (marketed as Farxiga in the US and Forxiga outside the US) is part of a class of medicines called sodium-glucose cotransporter 2 inhibitors (SGLT-2i) used to manage type-2 diabetes, which remove glucose via the kidneys.
Farxiga (dapagliflozin) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes. Farxiga is not indicated to reduce the risk of CV events, death or hospitalisation for heart failure.
There are three ongoing outcomes trials for dapagliflozin. DECLARE is a robust randomised, double-blind, multicentre, placebo-controlled cardiovascular outcomes trial enrolling more than 17,000 patients around the world, designed to evaluate the cardiovascular outcomes of dapagliflozin compared with placebo in addition to standard of care, in adults with T2D and high risk of cardiovascular disease (either established cardiovascular disease or multiple cardiovascular risk factors). DECLARE is ongoing and expected to provide data in 2019 at the latest. In addition to DECLARE, AstraZeneca has initiated two outcomes trials, the DAPA-HF and DAPA-CKD trials, to help to define the potential role of dapagliflozin in the management of chronic heart failure and chronic kidney disease respectively, in people with and without type-2 diabetes. Dapagliflozin is not indicated to reduce the risk of cardiovascular events, death, heart failure or the progression of chronic kidney disease.
About AstraZeneca in Diabetes
AstraZeneca is pushing the boundaries of science with the goal of developing life-changing medicines that aim to reduce the global burden and complications of diabetes. As a core therapy area for the company, we are focusing our research and development efforts on diverse populations and patients with significant co-morbidities, such as cardiovascular disease, obesity, non-alcoholic steatohepatitis (NASH), and chronic kidney disease.
Our commitment to diabetes is exemplified by the depth and breadth of our global clinical research programme. This commitment is advancing understanding of the treatment effects of our diabetes medicines in broad patient populations, as well as exploring combination product approaches to help more patients achieve treatment success earlier in their disease progression. Our ambition is to reduce the long-term impact of diabetes.
About AstraZeneca in Cardiovascular and Metabolic Diseases
Cardiovascular, renal and metabolic diseases are key areas of focus for AstraZeneca as part of the company’s strategy for achieving scientific leadership and returning to growth. By collaborating across therapeutic disciplines within the CVMD therapy area, we are addressing the underlying disorders that drive CVMD risk, with the goal of reducing morbidity, mortality and organ damage through innovative therapies. Recognising the growing unmet needs and challenges faced by the millions of people worldwide living with these interrelated diseases, we are determined to understand how they interact and impact one another – and how they can be treated together to save more patients’ lives.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.