TIDMAZN
RNS Number : 8028K
AstraZeneca PLC
02 September 2019
02 September 2019 07:00 BST
Brilinta reduced the risk of cardiovascular events in patients
with
coronary artery disease and type-2 diabetes in Phase III THEMIS
trial
Additionally, Brilinta showed a more favourable clinical benefit
in a prespecified
sub-analysis of patients who had undergone a procedure to open a
coronary artery
AstraZeneca today announced detailed results from the positive
Phase III THEMIS trial which showed Brilinta (ticagrelor) plus
aspirin reduced the relative risk for the composite of
cardiovascular (CV) death, heart attack, or stroke by 10% compared
with aspirin alone, a statistically significant reduction.
The overall THEMIS trial population was patients with coronary
artery disease (CAD) and type-2 diabetes (T2D) with no prior heart
attack or stroke.
Additionally, in a clinically meaningful and prespecified
sub-analysis of patients who had previously undergone a
percutaneous coronary intervention (PCI), a procedure to open a
blocked or narrowed coronary artery, a 15% relative risk reduction
was observed for Brilinta plus aspirin for the composite of CV
death, heart attack, or stroke, compared with aspirin alone.
The safety profile for Brilinta was consistent with the known
profile of the medicine with an increased risk of bleeding events
observed in both THEMIS and the THEMIS-PCI sub-analysis.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "These positive results show that Brilinta reduced
the risk of cardiovascular events in patients with coronary artery
disease and type-2 diabetes, and we hope this will make a
difference because their risk of heart attack or stroke is almost
twice as high as it is among diabetes patients without
cardiovascular disease. Also, for the first time, these new data
identified an easily-recognisable sub-group of stable patients who
may benefit most from Brilinta - those with type-2 diabetes who
have undergone PCI."
Deepak L. Bhatt, MD, MPH, THEMIS Co-Chair and Executive Director
of Interventional Cardiovascular Programs at Brigham and Women's
Hospital, and Professor of Medicine at Harvard Medical School,
Boston, US said: "So far, treatment options have been limited for
patients with coronary artery disease and type-2 diabetes. The
results from THEMIS greatly advance our understanding of
cardiovascular risk reduction and refine our understanding of the
role of dual antiplatelet therapy in patients across the
cardiovascular spectrum."
Gabriel Steg, MD, THEMIS Co-Chair and Professor at Université de
Paris, said: "Patients with type-2 diabetes who had undergone a
percutaneous coronary intervention, face a similar risk of a
cardiovascular event as those who have had a heart attack. The PCI
population is a sizeable and easily identifiable group of patients
where we saw a more favourable net clinical benefit, that we hope
in the future will be considered for long-term therapy with
Brilinta and aspirin."
AstraZeneca will work with regulatory authorities to explore an
update to the Brilinta label based on these results.
Results from THEMIS and THEMIS-PCI were presented on Sunday 1
September 2019 at the ESC Congress 2019 (the annual meeting of the
European Society of Cardiology) in Paris, France. The results for
the overall THEMIS trial were published simultaneously in the New
England Journal of Medicine(1) and results from THEMIS-PCI were
published in The Lancet.(2)
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, compared
with aspirin alone. CAD was defined as a 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.
THEMIS-PCI is a clinically meaningful and prespecified
sub-analysis of patients (11,154 which is 58% of total patients)
who had previously undergone percutaneous coronary intervention
(PCI).
About Brilinta
Brilinta 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 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 comorbidities. 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.
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References
1. Steg P.G et al. Ticagrelor in Patients with Stable Coronary
Disease and Diabetes. New England Journal of Medicine.
2. Bhatt D.L et al. Ticagrelor in patients with diabetes and
stable coronary artery disease with a history of previous
percutaneous coronary intervention (THEMIS-PCI): a phase 3,
placebo-controlled, randomised trial. The Lancet.
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