New ESC Guidelines Recommend BRILIQUE (ticagrelor) in all Moderate-To-High Risk Patients With Non-ST Elevation Acute Coronary Syndromes

AsiaNet 46099

PARIS, Aug. 30 /PRNewswire-AsiaNet/ —

– This release is not intended for US media

Ticagrelor Recommended for Medically & Invasively Managed
NSTE-ACS Patients Regardless of Prior Treatment with Clopidogrel

AstraZeneca today announced BRILIQUE (ticagrelor), a new oral
antiplatelet medicine, received a Class I recommendation (level of evidence
B) from the European Society of Cardiology (ESC) in the revised “Guidelines
for Management of Acute Coronary Syndromes (ACS) in patients presenting
without persistent ST-segment elevation.”

In these 2011 guidelines, ticagrelor is recommended for all non-ST
elevation ACS patients at moderate-to-high risk of ischaemic events,
regardless of initial treatment strategy and including those pre-treated
with clopidogrel (which should be discontinued when ticagrelor is commenced)
(Class 1, level of evidence B). In addition, the guidelines recommend
ticagrelor be considered for initiation or resumption following coronary
artery bypass graft (CABG) surgery as soon as it is considered safe (Class
IIa, level of evidence B).

“The inclusion of ticagrelor in the new NSTE-ACS ESC guidelines is
another important step toward improving ACS patient care in the EU,” said
Professor Lars Wallentin, co-primary investigator of the PLATO study and
Professor of Cardiology and Research Director at the Uppsala University,

The ESC guidelines as well as marketing authorisation in the EU for
ticagrelor were based on a review of the ticagrelor clinical programme,
including results from PLATO (A Study of PLATelet Inhibition and Patient
Outcomes), which established the superiority of ticagrelor over clopidogrel,
and showed that treating 54 ACS patients with ticagrelor instead of
clopidogrel for one year prevented one atherothrombotic event and treating
91 patients prevented one cardiovascular (CV) death, with no increase in
overall major/fatal bleeding over the course of one year of treatment (11.6%
for ticagrelor versus 11.2% for clopidogrel, p=0.43). However, non-CABG
major bleeding was more common with ticagrelor versus clopidogrel (4.5% vs.
3.8%, p=0.03).

On 6 December 2010, the European Commission granted marketing
authorisation to ticagrelor, co-administered with acetylsalicylic acid (ASA)
(maintenance dose 75-150mg daily), for the prevention of atherothrombotic
events in adult patients with ACS (unstable angina, NSTEMI, or STEMI),
including patients managed medically and those who are managed with
percutaneous coronary intervention (PCI) or CABG. This decision followed
advance incorporation of the medicine into ESC’s 2010 Guidelines for
Myocardial Revascularisation
] in August.

These updates to the 2011 Guidelines for Management of Acute Coronary
Syndromes (ACS) in patients presenting without persistent ST-segment
have been featured in an ESC press release
and presented at an ESC press
conference on Monday, 29th August in Paris, France, while simultaneously
being published in the European Heart Journal. Ticagrelor is also
recommended for treatment of ACS in the Canadian Cardiovascular Society



Class I indicates “evidence and/or general agreement that a given
treatment or procedure is beneficial, useful, effective,” while level of
evidence B signifies that this recommendation was based upon a single
randomised clinical trial. Class IIa indicates the “weight of
evidence/opinion is in favour of usefulness/efficacy.”

PLATO was a large (18,624 patients in 43 countries), head-to-head patient
outcomes study of ticagrelor versus clopidogrel, both given in combination
with aspirin and other standard therapy, designed to establish whether
ticagrelor could achieve a clinically meaningful reduction in CV end points
in ACS patients, above and beyond those afforded by clopidogrel.

The study demonstrated that treatment with BRILIQUE led to a greater
reduction in the primary end point – a composite of CV death, MI, or stroke
– compared to patients who received clopidogrel [9.8% vs. 11.7% at 12
months, 1.9% absolute risk reduction (ARR), 16% relative risk reduction
(RRR), 95% CI, 0.77 to 0.92, p<0.001]. The difference in treatments was
driven by CV death and MI with no difference in stroke. In PLATO, the
absolute difference in treatment benefit versus clopidogrel was seen at 30
days and the Kaplan-Meier survival curves continued to diverge throughout
the 12-month treatment period.

The study also demonstrated that treatment with BRILIQUE for 12 months
was associated with a 21 percent RRR in CV death (4% vs. 5.1%, 1.1% ARR,
p=0.001) and a 16 percent RRR in MI compared to clopidogrel at 12 months
(5.8% vs. 6.9%, 1.1% ARR, p<0.005).

The results of this analysis formed the basis of the recommendation in
all of the approved BRILIQUE labels that patients taking BRILIQUE should
also take a low-maintenance dose of aspirin daily, unless specifically

About BRILIQUE (ticagrelor tablets)

BRILIQUE is an oral antiplatelet treatment for ACS. BRILIQUE is a
direct-acting P2Y12 receptor antagonist in a new chemical class called
cyclopentyltriazolopyrimidines (CPTPs). BRILIQUE is the first
reversibly-binding oral ADP receptor antagonist to be approved for use in

BRILINTA has now been approved in 43 countries, including in the
European Union under the trade name BRILIQUE and in the United States,
Canada, Brazil, Malaysia and Macau under the trade name BRILINTA. BRILINTA
is currently under regulatory review in 49 countries, including Russia,
India and China.

BRILINTA and BRILIQUE are trademarks of the AstraZeneca group of
companies. For detailed information regarding BRILINTA / BRILIQUE, please
refer to the local Summary of Product Characteristics.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business
with a primary focus on the discovery, development and commercialisation of
prescription medicines. As a leader in gastrointestinal, cardiovascular,
neuroscience, respiratory and inflammation, oncology and infectious disease
medicines, AstraZeneca generated global revenues of US $33.3 billion in
2010. For more information please visit:

SOURCE: AstraZeneca