(NYSE: AZN) today announced results from a post-hoc analysis of a
sub-group of the PLATO study. This new analysis evaluated outcomes in
9,946 patients with non–ST-elevation acute coronary syndrome (NSTE-ACS)
managed with or without in-hospital revascularization in relation to
measurements at randomization of high-sensitivity troponin-T (hs-TnT), a
biomarker test that may be a more sensitive indicator of ongoing heart
muscle damage than previously available troponin tests.
This study was presented today at the American Heart Association (AHA)
Scientific Sessions in Los Angeles, CA. In the 86.3% (n= 8,587) of
NSTE-ACS patients in PLATO with elevated hs-TnT, BRILINTA®
(ticagrelor) tablets reduced the composite of cardiovascular (CV) death,
myocardial infarction (MI), and stroke, consistent with the results for
the overall population of the PLATO study. In the 13.7% (n=1,359)
patients with normal hs-TnT, the confidence intervals around the hazard
ratios were broad. Because of the limited number of patients without
hs-TnT elevation, uncertainties remain regarding the effects of
ticagrelor versus clopidogrel on outcomes in hs-TnT normal subgroups.
“Hs-TnT is an important new biomarker that provides a much better
ability to identify patients with ongoing myocardial damage. This
biomarker allowed identification of NSTE-ACS patients with low levels of
myocardial damage that would not have been detected by previous testing,”said James Ferguson, MD, Executive Director, Medical Affairs and
Strategic Development, and Vice President for Global Medical Affairs.
“This analysis of PLATO shows BRILINTA reduced the rate of thrombotic CV
events in those NSTE-ACS patients with elevated hs-TNT, both when
managed with revascularization as well as when managed medically.”
BRILINTA is indicated to reduce the rate of thrombotic CV events in
patients with ACS (unstable angina [UA], non–ST-elevation myocardial
infarction [NSTEMI], or ST-elevation myocardial infarction [STEMI]). In
PLATO, BRILINTA has been shown to reduce the rate of a combined end
point of CV death, MI, or stroke compared to clopidogrel. In PLATO, 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 stent thrombosis.
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.
Bleeding rates and adverse events were not assessed in this sub-group
analysis. 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
versus 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.
Specific findings from this post-hoc analysis include:
IMPORTANT SAFETY INFORMATION ABOUT BRILINTA (ticagrelor) TABLETS
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).
– ENDS –
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 versus 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 versus clopidogrel was seen at 30 days and the Kaplan-Meier
survival curves continued to diverge throughout the 12-month treatment
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 versus
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 include unstable
angina (UA), non–ST-elevation myocardial infarction (NSTEMI), and
ST-elevation myocardial infarction (STEMI). The conditions are defined
by ECG changes and heart muscle enzyme leakage. Non–ST-elevation acute
coronary syndrome (NSTE-ACS) includes unstable angina (UA) and
non–ST-elevation myocardial infarction (NSTEMI); the term is usually
used before heart muscle enzymes have been analyzed.
AstraZeneca is a global, innovation-driven biopharmaceutical business
with a primary focus on the discovery, development and commercialization
of prescription medicines for gastrointestinal, cardiovascular,
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medicines are used by millions of patients worldwide.
For more information about AstraZeneca in the U.S. or our AZ&Me™
Prescription Savings programs, please visit: www.astrazeneca-us.com
or call 1-800-AZandMe (292-6363).