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2019-02-25

AstraZeneca: Brilinta's Phase III THEMIS trial met primary endpoint in patients with established coronary artery disease an...

Brilinta reduced cardiovascular events in patients with no prior heart
attack or stroke

The Phase III THEMIS trial met its primary endpoint and demonstrated
that Brilinta (ticagrelor), taken in conjunction with aspirin, showed
a statistically-significant reduction in a composite of major adverse
cardiovascular events (MACE) compared to aspirin alone.

THEMIS was conducted in over 19,000 patients with coronary artery
disease (CAD) and type-2 diabetes (T2D) with no prior heart attack
(myocardial infarction, MI) or stroke. Preliminary safety results
were consistent with the known profile of Brilinta. A full evaluation
of the THEMIS data will be presented at a forthcoming medical
meeting.

Elisabeth Björk, Senior Vice President, Head of late Cardiovascular,
Renal and Metabolism, R&D BioPharmaceuticals, said: "Approaches to
help reduce cardiovascular morbidity further in patients with
coronary artery disease and type-2 diabetes are urgently needed. The
positive result from the THEMIS trial may offer a potential benefit
for this high-risk patient population."

Deepak L. Bhatt, MD, MPH, THEMIS co-Chair and Executive Director of
Interventional Cardiovascular Programs at Brigham and Women's
Hospital and a Professor at Harvard Medical School said: "The THEMIS
trial is the largest randomised trial of patients with type-2
diabetes performed to date and was designed to evaluate whether
more-intense antiplatelet therapy is a promising approach. The
results could help us refine our understanding of the role of dual
antiplatelet therapy in patients across the atherothrombotic
spectrum."

Gabriel Steg, MD, THEMIS co-Chair and Professor at Université
Paris-Diderot, Paris and Professor at the National Heart and Lung
Institute, Imperial College, London said: "Patients who have both
stable coronary artery disease and diabetes are a sizeable group
which remains at particularly high risk of major adverse cardiac
events. The optimal long-term antiplatelet therapy in that group is
not fully established. We look forward to presenting the full results
from the THEMIS trial later this year."

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 CAD
and 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, in patients with CAD and T2D
with no prior myocardial infarction or stroke, vs. aspirin alone. CAD
was defined as a prior percutaneous coronary intervention (PCI),
bypass surgery or at least a 50% narrowing of a coronary artery.

The trial was initiated in early 2014, duration was event-driven
across 42 countries and more than 19,000 patients were randomised in
order to collect 1,385 independently-adjudicated primary endpoint
events.

About Brilinta

Brilinta (ticagrelor) is an oral, reversible, direct-acting P2Y12
receptor antagonist that works by inhibiting platelet activation.
Brilinta, together with aspirin, has been shown to significantly
reduce the risk of major adverse cardiovascular events (myocardial
infarction, stroke or CV death), in patients with acute coronary
syndrome (ACS) or a history of MI.

Brilinta, co-administered with aspirin is indicated for the prevention
of atherothrombotic events in adult patients with ACS, or for
patients with a history of MI and a high risk of developing an
atherothrombotic event.

About AstraZeneca in Cardiovascular, Renal & Metabolism (CVRM)

Cardiovascular, renal and metabolism is one of AstraZeneca's main
therapy areas and platforms for future growth. By following the
science to understand more clearly the underlying links between the
heart, kidney 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. Our
ambition is to modify or halt the natural course of these diseases
and even regenerate organs and restore function, by continuing to
deliver transformative science that improves treatment practices and
CVRM 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, Cardiovascular, Renal & Metabolism
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
(http://www.astrazeneca.com/) and follow us on Twitter @AstraZeneca
(https://twitter.com/AstraZeneca).

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