(NYSE: AZN) announced today that a combined panel of experts from the
American College of Cardiology Foundation (ACCF) and American Heart
Association (AHA) have updated their guidelines to include a Class I
recommendation for use of the oral antiplatelet (OAP) medicine BRILINTA®
(ticagrelor) tablets in patients with ST-elevation myocardial infarction
(STEMI) managed invasively.1 With this latest guidelines
update, BRILINTA is included in more than 10 major acute coronary
syndrome (ACS) treatment guidelines globally.1-11
"The U.S. Cardiology community is again acknowledging the clinical value
of BRILINTA," said James Ferguson, MD, Executive Director, Medical
Affairs and Strategic Development, US, and Vice President for Global
Medical Affairs. "This significant milestone, along with the inclusion
in the NSTEMI Guidelines in July, solidifies the position of BRILINTA in
multiple ACS guidelines as an important part of standard of care for
both STEMI and NSTEMI patients."2
A Class I recommendation is the highest recommendation provided by the
Following are specific Class I and Class IIa recommendations within the
guidelines relating to OAPs, including BRILINTA, as well as the use of
aspirin (the recommended maintenance dose of aspirin to be used with
ticagrelor is 81 mg daily):
Antiplatelet Therapy to Support Primary
Percutaneous Coronary Intervention (PCI) for STEMI: Recommendations
1. Aspirin 162 to 325 mg should be given before primary PCI. (Level
of Evidence (LOE): B)
2. After PCI, aspirin should be continued indefinitely. (LOE:
3. A loading dose of a P2Y12 receptor
inhibitor should be given as early as possible or at time of
primary PCI to patients with STEMI. Options include:
a. Clopidogrel 600 mg (LOE: B); or
b. Prasugrel 60 mg (LOE: B); or
c. Ticagrelor 180 mg (LOE: B)
4. P2Y12 inhibitor therapy should be
given for 1 year to patients with STEMI who receive a stent
(bare-metal stent [BMS] or drug-eluting stent [DES]) during
primary PCI using the following maintenance doses:
a. Clopidogrel 75 mg daily (LOE: B); or
b. Prasugrel 10 mg daily (LOE: B); or
c. Ticagrelor 90 mg twice a day (LOE: B)
1. It is reasonable to use 81 mg of aspirin per day in
preference to higher maintenance doses after primary PCI. (LOE:
2. It is reasonable to begin treatment with an intravenous GP
IIb/IIIa receptor antagonist such as abciximab (LOE: A),
high-bolus-dose tirofiban (LOE: B), or double-bolus
eptifibatide (LOE: B) at the time of primary PCI (with or
without stenting or clopidogrel pre-treatment) in selected
patients with STEMI who are receiving unfractionated heparin (UFH).
BRILINTA is indicated to reduce the rate of thrombotic cardiovascular
(CV) events in patients with acute coronary syndrome (ACS: unstable
angina [UA], non-ST-elevation myocardial infarction [NSTEMI], or
ST-elevation myocardial infarction [STEMI]). BRILINTA has been shown to
reduce the rate of a combined end point of CV death, myocardial
infarction (MI), or stroke compared to clopidogrel. The difference
between treatments was driven by CV death and MI with no difference in
stroke. In patients treated with an artery-opening procedure known as
percutaneous coronary intervention (PCI), BRILINTA reduces the rate of
BRILINTA has been studied in ACS in combination with aspirin.
Maintenance doses of aspirin above 100 mg decreased the effectiveness of
BRILINTA. Avoid maintenance doses of aspirin above 100 mg daily.
Since receiving FDA approval in July 2011, BRILINTA has now been added
to six established treatment guidelines in the US. In July 2012, a
combined panel of experts from the ACCF and AHA updated their guidelines
to include a Class I recommendation for the use of BRILINTA in patients
with Unstable Angina (UA) or NSTEMI, managed both invasively or
In February 2012, the American College of Chest Physicians (ACCP)
updated its guidelines for Antithrombotic Therapy to include a
recommendation for administering BRILINTA with low-dose aspirin to
patients in the first year after ACS who have not undergone PCI or who
have undergone PCI with stent placement. This was the first time that
clinical treatment guidelines in the US specifically suggested use of
BRILINTA over clopidogrel, as a grade 2B recommendation.3
In November 2011, a combined expert committee from ACCF, AHA and the
Society for Cardiovascular Angiography and Interventions (SCAI) updated
its guidelines for the management of patients undergoing PCI to provide
a Class I recommendation for giving BRILINTA to patients with ACS
undergoing PCI with stenting.4 Additionally, AHA/ACCF also
revised their Guidelines on Secondary Prevention and Risk Reduction
Therapy to include BRILINTA, in combination with low-dose aspirin, as a
Class I therapy to be taken twice daily for at least 12 months in
patients receiving a bare-metal stent (BMS) or drug-eluting stent (DES)
during PCI for ACS.5
The ACCF/AHA guidelines for CABG, released in November 2011, include a
Class I recommendation that BRILINTA should be discontinued for at least
5 days before surgery, in patients referred for elective CAGB.6
IMPORTANT SAFETY INFORMATION ABOUT BRILINTA
WARNING: BLEEDING RISK
WARNING: ASPIRIN DOSE AND BRILINTA EFFECTIVENESS
WARNINGS AND PRECAUTIONS
Please read full Prescribing
Information, including Boxed WARNINGS, and Medication
Guide. This information can be found at www.BRILINTAtouchpoints.com.
You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit. www.fda.gov/safety/medwatch.
For patients that require BRILINTA beyond their hospital stay, a savings
card program is available based on eligibility. Commercially insured and
cash-paying patients may be eligible for one free 30-day prescription
and can save up to $825 per year on their next 11 refills. For each
refill (a 30-day supply of up to 60 tablets), savings may apply after
the first $18 spent by a patient, up to a $75 savings limit. Patients
covered through Medicare, Medicaid or similar federal or state programs
may be eligible for one month free prescription. Patients can find out
more at www.BRILINTAtouchpoints.com
or by calling 1-888-412-7454.
AstraZeneca also offers a U.S. patient assistance program for BRILINTA
through its AZ&MeTM Prescription Savings Program. To
determine eligibility, patients can visit www.AZandMe.com
or call 1-800-AZandMe (292-6363).
NOTES TO EDITORS
About BRILINTA® (ticagrelor) tablets
BRILINTA is an oral antiplatelet treatment for ACS. BRILINTA is a
direct-acting P2Y12 receptor antagonist in a chemical class
called cyclopentyltriazolopyrimidines (CPTPs). BRILINTA works by
inhibiting platelet activation and has been shown to reduce the rate of
thrombotic CV events, such as a heart attack or CV death, in patients
BRILINTA is available in 90-mg tablets to be administered with a single
180-mg oral loading dose (two 90-mg tablets) followed by a twice daily,
90-mg maintenance dose. Following an initial loading dose of aspirin,
BRILINTA should be used with a maintenance dose of 75 mg - 100 mg
aspirin once daily, 81-mg aspirin dose in the US.
BRILINTA is a registered trademark of the AstraZeneca group of companies.
PLATO (PLATelet Inhibition and Patient Outcomes) was a large (18,624
patients in 43 countries), head-to-head patient outcomes study of
BRILINTA vs clopidogrel, both given in combination with aspirin and
other standard therapy. The study was designed to establish whether
BRILINTA could achieve a clinically meaningful reduction in
cardiovascular (CV) events in acute coronary syndrome (ACS) patients,
above and beyond that afforded by clopidogrel. Patients were treated for
at least 6 months and up to 12 months.
PLATO demonstrated that treatment with BRILINTA led to a significantly
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 vs clopidogrel was seen at 30 days and the Kaplan-Meier survival
curves continued to diverge throughout the 12-month treatment period.
The PLATO study also demonstrated that treatment with BRILINTA for 12
months was associated with a 21% RRR in CV death (4% vs 5.1%; 1.1% ARR; P=0.001)
and a 16% RRR in MI compared to clopidogrel at 12 months (5.8% vs 6.9%;
1.1% ARR; P<0.005).
The primary safety end point in the PLATO study was Total Major Bleeding
(11.6% for BRILINTA and 11.2% for clopidogrel). In PLATO, non-CABG major
+ minor bleeding events were more common with BRILINTA vs clopidogrel
(8.7% vs 7% respectively). The rate of non-CABG-related major bleeding
was higher for BRILINTA (4.5%) vs clopidogrel (3.8%).
Dyspnea was reported in 14% of patients treated with BRILINTA and in 8%
of patients treated with clopidogrel. Dyspnea was usually mild to
moderate in intensity and often resolved during continued treatment.
About Acute Coronary Syndrome (ACS)
ACS is an umbrella term for conditions that result from insufficient
blood supply to the heart muscle. These conditions range from unstable
angina (UA), non-ST-elevation myocardial infarction (NSTEMI), or
ST-elevation myocardial infarction (STEMI).
AstraZeneca is a global, innovation-driven biopharmaceutical business
with a primary focus on the discovery, development and commercialization
of prescription medicines for gastrointestinal, cardiovascular,
neuroscience, respiratory and inflammation, oncology and infectious
disease. AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide.
For more information about AstraZeneca in the US or our AZ&Me™
Prescription Savings programs, please visit: www.astrazeneca-us.com
or call 1-800-AZandMe (292-6363).
O'Gara, P. et al. Circulation. 2012.
Jneid, H. et. al. Journal of the American College of Cardiology.
Guyatt, G. et. al. Chest. 2012. doi:10.1378/chest.1412S3
Levine, G. et. al. Journal of the American College of
Cardiology. 2011. doi:10.1016/j.jacc.08.007
Smith, S. et. al. Circulation. 2011.
Hillis, D. et. al. Journal of the American College of
Cardiology. 2011. doi:10.1016/j.jacc.2011.08.009
Steg, G. et. al. European Heart Journal. 2012.
Hamm, C. et. al. European Heart Journal. 2011.
Wijns, W. et. al. European Heart Journal. 2010.
Perk, J. et. al. European Heart Journal. 2012.
Bell, A. et. al. Canadian Journal of Cardiology. 2011.
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