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:
|Lead author||Abstract title||Presentation details|
|Jones, WS||Effect of Hypertension and Systolic Blood Pressure on Cardiovascular and Limb Outcomes in Patients with Symptomatic Peripheral Artery Disease: the EUCLID Trial.||Poster Presentation: #P935. Saturday 31 August, 11:00-16:00, Posters – Poster Area|
|Russo, J||Predictors of DAPT Use in Patients Beyond One-Year Post-Myocardial Infarction: Insights from the TIGRIS Observational Study.||Moderated Poster Presentation: #1932. Sunday 1 September, 12:40-13:30, Moderated ePoster 2 – Poster Area|
|Hasvold, P||Cardiovascular Outcome in THEMIS-like Type-2 Diabetes Patients in Sweden: A Nationwide Observational Study.||Poster Presentation: #2207. Sunday 1 September, 14:30-14:38, Agora 2 – Poster Area|
|Bhatt, D||THEMIS – Main Results of the Effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study.||Late-Breaking Science: #2097. Sunday 1 September, 14:30-14:43, Paris – Main Auditorium Session|
|Steg, G||THEMIS-PCI: Ticagrelor in Patients with Diabetes and Stable Coronary Artery Disease with a History of Prior Percutaneous Coronary Intervention.||Late-Breaking Science: #2098. Sunday 1 September, 14:43-14:48, Paris – Main Auditorium|
|Nicolau, JC||Baseline Characteristics, Healthcare Resource Use and Clinical Outcomes of Stable Post-Myocardial Infarction Patients with Diabetes: Insights from the Global Prospective TIGRIS Study.||Poster Presentation: #P5471. Tuesday 3 September, 8:30-12:30, Posters - Poster Area|
|Danchin, N||Diabetes and Heart Failure after Acute Myocardial Infarction. The FAST-MI Programme.||Late-Breaking Science: #5904. Tuesday 3 September, 14:48-15:06, Budapest – Village 5|
|Zelniker, T||Effect of Dapagliflozin on Cardiovascular Outcomes in Patients with Type-2 Diabetes According to Baseline Renal Function and Albuminuria Status: Insights from DECLARE-TIMI 58.||Oral Presentation: #192. Saturday 31 August, 11:18-11:36, Reykjavik – Village 2|
|Berg, D||Heart Failure Risk Stratification and Efficacy of Dapagliflozin in Patients with Type-2 Diabetes Mellitus.||Oral Presentation: #410. Saturday 31 August, 14:37-14:55, Reykjavik – Village 2|
|McMurray, J||DAPA-HF – The Dapagliflozin and Prevention of Adverse-outcomes in Heart Failure Trial.||Late-Breaking Science. Sunday 01 September, 15:38 – 15:51, Paris – Main Auditorium|
For a complete list of AstraZeneca data presentations at ESC Congress 2019, please access the ESC Congress website here.
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.
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.
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