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AstraZeneca: 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

Key AstraZeneca abstracts at the ESC Congress 2019 include:

Lead Abstract title Presentation details
Jones, WS Effect of Poster Presentation: #P935. Saturday 31 August,
Hypertension and 11:00-16:00, Posters - Poster Area
Systolic Blood
Pressure on
and Limb
Outcomes in
Patients with
Artery Disease:
Russo, J Predictors of Moderated Poster Presentation: #1932. Sunday 1
DAPT Use in September, 12:40-13:30, Moderated ePoster 2 -
Patients Beyond Poster Area
One-Year Post
Insights from
Hasvold, Cardiovascular Poster Presentation: #2207. Sunday 1 September,
P Outcome in 14:30-14:38, Agora 2 - Poster Area
THEMIS-like Type
-2 Diabetes
Patients in
Sweden: A
Bhatt, D THEMIS - Main Late-Breaking Science: #2097. Sunday 1 September,
Results of the 14:30-14:43, Paris - Main Auditorium Session
Effect of
Ticagrelor on
Health Outcomes
in Diabetes
Steg, G THEMIS-PCI: Late-Breaking Science: #2098. Sunday 1 September,
Ticagrelor in 14:43-14:48, Paris - Main Auditorium
Patients with
Diabetes and
Stable Coronary
Artery Disease
with a History
of Prior
Nicolau, Baseline Poster Presentation: #P5471. Tuesday 3 September,
JC Characteristics, 8:30-12:30, Posters - Poster Area
Resource Use and
Outcomes of
Stable Post
Patients with
Insights from
the Global
Danchin, Diabetes and Late-Breaking Science: #5904. Tuesday 3
N Heart Failure September, 14:48-15:06, Budapest - Village 5
after Acute
Infarction. The
Zelniker, Effect of Oral Presentation: #192. Saturday 31 August,
T Dapagliflozin on 11:18-11:36, Reykjavik - Village 2
Outcomes in
Patients with
Type-2 Diabetes
According to
Baseline Renal
Function and
Status: Insights
-TIMI 58.
Berg, D Heart Failure Oral Presentation: #410. Saturday 31 August,
Risk 14:37-14:55, Reykjavik - Village 2
and Efficacy of
Dapagliflozin in
Patients with
Type-2 Diabetes
McMurray, DAPA-HF - The Late-Breaking Science. Sunday 01 September, 15:38
J Dapagliflozin - 15:51, Paris - Main Auditorium
and Prevention
of Adverse
-outcomes in
Heart Failure

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 outcomes investigating 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.

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 ( and follow us on
Twitter @AstraZeneca (

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