AstraZeneca to present data at ESC Congress 2019 that potentially redefines the treatment of heart failure

Farxiga DAPA-HF trial demonstrates significant benefits in patients with heart failure with and without diabetes

Brilinta THEMIS trial shows potential in treating patients with CAD and T2D before they experience a heart attack or stroke

New insights from the Farxiga DECLARE-TIMI 58 trial build on the extensive body of evidence in patients with type-2 diabetes who have a high cardiovascular and renal risk

AstraZeneca will present results from the Farxiga (dapagliflozin) Phase III DAPA-HF trial at the ESC Congress in Paris, making Farxiga the first medicine in its class to move into a new disease area by demonstrating efficacy and safety data for the treatment of patients with heart failure.

The results of the DAPA-HF trial in patients with and without type-2 diabetes (T2D), on top of standard of care, is among 28 abstracts that will be presented by AstraZeneca at the congress that takes place from 31 August to 4 September 2019.

Three late-breaking abstracts will be presented on Sunday 1 September, including results from the Brilinta Phase III THEMIS trial and THEMIS-PCI, a sub-analysis of patients with T2D and coronary artery disease (CAD) who had undergone percutaneous coronary intervention. Additionally, new insights from DECLARE-TIMI 58 examine the potential of Farxiga to reduce the rate of adverse CV events in patients with T2D, both with and without kidney disease.

Joris Silon, Senior Vice President, Cardiovascular, Renal and Metabolism, BioPharmaceuticals said: “The presentation of our Phase III trials at the ESC Congress clearly demonstrates AstraZeneca’s commitment to advance treatments where there is a need to improve patient outcomes in cardiovascular disease. With the Farxiga DAPA-HF trial, we explored the potential benefits of this medicine, an SGLT2 inhibitor, for the treatment of patients with heart failure, with and without type-2 diabetes. With Brilinta, the THEMIS trial demonstrated the potential of this medicine in patients with coronary artery disease and diabetes who are at high-risk of having a cardiovascular event.”

Key AstraZeneca abstracts at the ESC Congress 2019 include:

For a complete list of AstraZeneca data presentations at ESC Congress 2019, please access the ESC Congress website here.

About DAPA-HF

DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure) is the first heart failure trial with an SGLT2 inhibitor and morbidity and mortality outcomesinvestigating the treatment of heart failure on top of standard of care, in a representative patient population (NYHA II to IV) with and without type-2 diabetes. DAPA-HF is an international, multi-centre, parallel group, randomised, double-blind trial in patients with heart failure and reduced ejection fraction (LVEF ≤ 40%), with and without type-2 diabetes, designed to evaluate the effect of Farxiga 10mg, compared with placebo, given once daily in addition to standard of care. The primary composite outcome was time to a worsening heart failure event (hospitalisation or equivalent event; i.e. an urgent heart failure visit), or cardiovascular death.

About THEMIS

THEMIS (Effect of Ticagrelor on Health Outcomes in DiabEtes Mellitus Patients Intervention Study) is an AstraZeneca-sponsored, multi-national, randomised, double‑blinded trial in patients with coronary artery disease (CAD) and type-2 diabetes (T2D) with no prior myocardial infarction or stroke. THEMIS was designed to test the hypothesis that Brilinta plus aspirin would reduce major adverse cardiovascular events (MACE), a composite of CV death, myocardial infarction or stroke, compared to aspirin alone. CAD was defined as a history of percutaneous coronary intervention (PCI), bypass surgery or at least a 50% narrowing of a coronary artery. More than 19,000 patients were randomised across 42 countries in Europe, Asia, Africa, North and South America.

About AstraZeneca in CVRM

Cardiovascular, Renal & Metabolism (CVRM) together forms one of AstraZeneca’s three therapy areas and is a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. The Company’s ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and cardiovascular health for millions of patients worldwide.

About AstraZeneca

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 therapy areas - Oncology, CVRM and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit astrazeneca.com and follow us on Twitter @AstraZeneca.