TIDMAZN
RNS Number : 9331A
AstraZeneca PLC
27 January 2020
27 January 2020 07:00 GMT
Brilinta met primary endpoint in Phase III THALES trial in
stroke
Brilinta reduced the risk of the composite of stroke and
death
after an acute ischaemic stroke or transient ischaemic
attack
High-level results from the Phase III THALES trial showed
AstraZeneca's Brilinta (ticagrelor) 90mg used twice daily and taken
with aspirin for 30 days, reached a statistically significant and
clinically meaningful reduction in the risk of the primary
composite endpoint of stroke and death, compared to aspirin
alone.
THALES was conducted in over 11,000 patients who had a minor
acute ischaemic stroke or high-risk transient ischaemic attack
(TIA) in the 24 hours prior to treatment initiation. The
preliminary safety findings in the THALES trial were consistent
with the known profile of Brilinta, with an increased bleeding rate
in the treatment arm.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "Results of the Phase III THALES trial showed
Brilinta, in combination with aspirin, improved outcomes in
patients who had experienced a minor acute ischaemic stroke or
high-risk transient ischaemic attack. We look forward to sharing
the detailed results with health authorities."
Dr. Clay Johnston, lead investigator for the THALES trial and
Dean of the Dell Medical School at The University of Texas at
Austin, US, said: "The risk of having a subsequent stroke is
highest in the first few days and weeks after a minor acute
ischaemic stroke or high-risk transient ischaemic attack. While an
expected increase in bleeding was observed, the findings from
THALES showed that Brilinta, in combination with aspirin, reduced
the risk of potentially devastating events in this crucial
time."
The full THALES trial results will be presented at a forthcoming
medical meeting.
Brilinta is approved in more than 110 countries for the
treatment of acute coronary syndrome (ACS) and in more than 70
countries for the secondary prevention of cardiovascular (CV)
events among high-risk patients who have experienced a heart
attack.
Stroke
Stroke is the second leading cause of death worldwide, with 6.2
million stroke-related deaths in 2017, from which 2.7 million were
due to ischaemic stroke.(1) Patients who experience an acute
ischaemic stroke or TIA are at high risk of developing subsequent
ischaemic events, with particularly high risk within 30 days after
the initial event and the highest risk period being the first 24
hours after the initial event.(2)
THALES
THALES is an AstraZeneca-sponsored, randomised,
placebo-controlled, double-blinded, international, multicentre,
event-driven trial involving more than 11,000 patients to test the
hypothesis whether Brilinta and aspirin is superior to aspirin
alone in preventing the composite of stroke and death in patients
with minor acute ischaemic stroke or high-risk TIA. Patients were
randomised within 24 hours of onset of acute ischaemic stroke or
high-risk TIA symptoms and followed-up for 30 days of treatment.
Trial treatments were Brilinta 180mg loading dose on day 1 as soon
as possible after randomisation, followed by 90mg twice daily on
days 2-30, or matching placebo. All patients received open-label
aspirin 300-325mg on day 1, followed by 75-100mg once daily on days
2-30. The primary efficacy outcome was the time to the composite
endpoint of stroke and death at 30 days. The primary safety outcome
is time to first severe bleeding event according to the Global
Utilization of Streptokinase and Tissue Plasminogen Activator for
Occluded Coronary Arteries (GUSTO) definition. Patients were
followed for an additional 30 days on standard of care.
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 CV events (myocardial infarction, stroke or
CV death), in patients with ACS or a history of myocardial
infarction (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.
AstraZeneca in CVRM
Cardiovascular, Renal and 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.
AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) 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 and Metabolism, and Respiratory.
AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. Please visit
astrazeneca.com and follow the Company on Twitter @AstraZeneca.
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References
1. Roth GA et al. Global, regional, and national
age-sex-specific mortality for 282 causes of death in 195 countries
and territories, 1980-2017: A systematic analysis for the Global
Burden of Disease Study 2017. The Lancet 2018;
392(10159):1736-88.
2. Khanevski AN, et al. Thirty-day recurrence after ischemic
stroke or TIA. Brain Behav 2018; 8(10):e01108.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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