Brilinta preferred over clopidogrel in updated American College of Cardiology and American Heart Association guideline in acute coronary syndrome

First major US guideline to include expanded indication for Brilinta in patients with a heart attack beyond one year

31 March 2016

AstraZeneca today confirmed that the American College of Cardiology (ACC) and American Heart Association (AHA) have released a treatment guideline on the duration of dual antiplatelet therapy (DAPT). Brilinta (ticagrelor) is now preferred over clopidogrel for the management of patients with acute coronary syndrome (ACS) who have received a coronary stent and in non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) patients treated with medical therapy alone (Class IIa LoE: B-R). This update is the first time the ACC/AHA has recommended Brilinta over clopidogrel for patients who have experienced an ST-elevation myocardial infarction (STEMI).

The update is also the first US guideline to provide the medical community with insights drawn from the PEGASUS-TIMI 54 trial. The guideline supports continuation of P2Y₁₂ therapy beyond 12 months in prior MI patients who are not at high bleeding risk (Class IIb LoE: A). Full details of the updated guideline are available on the ACC website.

Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development, AstraZeneca said: “We are pleased that the ACC/AHA have further recognised the role of Brilinta across a broad spectrum of ACS. This update reflects the clinical confidence in Brilinta as a treatment option for heart attack patients in the acute setting and in the longer-term.”

The US Food and Drug Administration approved Brilinta at a 60mg dose for patients with a history of heart attack in September 2015. Brilinta is the only P2Y₁₂ inhibitor that has been approved by the FDA in the past 10 years, for long-term use in patients with a history of MI. In the US, Brilinta is indicated to reduce the rate of CV death, MI, and stroke in patients with ACS or a history of MI. For at least the first 12 months following ACS, it has been proven superior to clopidogrel. Brilinta also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS.

This update comes ahead of the American College of Cardiology's 65^th Annual Scientific Sessions. Data will be presented on two new sub-analyses from the PEGASUS-TIMI 54 trial. The sub-analyses include prior MI patients with either peripheral artery disease (PAD) or diabetes. The data will be presented on 3 April and 4 April respectively.

In the second half of 2016, data are expected from the ongoing EUCLID trial in PAD, which is the fourth trial to read-out from the PARTHENON programme, assessing the potential of Brilinta in additional high-risk patient populations.

Notes to Editors

About the ACC/AHA Guidelines

The ACC/AHA Focused Update on the Duration of Dual Antiplatelet Therapy (DAPT) impacts six already released ACC/AHA Clinical Practice Guidelines. The scope of the update is limited to the duration of DAPT, as well as the effectiveness of DAPT compared to aspirin alone in patients with coronary artery disease.

Within the updated guideline, it is recommended that in patients with ACS (NSTE-ACS or STEMI) treated with DAPT after coronary stent implantation and in patients with NSTE-ACS treated with medical therapy alone (without revascularization), it is reasonable to use ticagrelor in preference to clopidogrel for maintenance P2Y12 inhibitor therapy.

Regarding longer-term use of DAPT beyond 12 months, the guidelines recommend that in patients with ACS (NSTE-ACS or STEMI) treated with coronary stent implantation who have tolerated DAPT without a bleeding complication and who are not at high bleeding risk (e.g., prior bleeding on DAPT, coagulopathy, oral anticoagulant use), continuation of DAPT (clopidogrel, prasugrel, or ticagrelor) for longer than 12 months may be reasonable (Class IIb). A new risk score (the “DAPT score”), derived from the Dual Antiplatelet Therapy study, may be useful for decisions about whether to continue (prolong or extend) DAPT in patients treated with coronary stent implantation. To access the full ACC/AHA guideline, visit http://www.acc.org/latest-in-cardiology/features/dual-antiplatelet-therapy-dapt-focused-update-hub?w_nav=CI.

About PEGASUS-TIMI 54

PEGASUS-TIMI 54 (PrEvention with TicaGrelor of SecondAry Thrombotic Events in High-RiSk Patients with Prior AcUte Coronary Syndrome – Thrombolysis In Myocardial Infarction Study Group) is one of AstraZeneca’s largest ever outcomes trials with  more than 21,000 patients from over 1,100 sites in 31 countries in Europe, the Americas, Africa and Australia/Asia. It is being conducted in collaboration with the Thrombolysis in Myocardial Infarction (TIMI) Study Group from Brigham and Women’s Hospital (Boston, MA, USA).

The PEGASUS-TIMI 54 study investigated the efficacy and safety of both Brilique 60mg and 90mg, twice daily, compared to placebo on a background of low dose aspirin, for the long-term prevention of atherothrombotic events in patients who suffered a heart attack one to three years prior to enrolment. The primary efficacy endpoint is time to first occurrence of any event from the composite endpoint of cardiovascular (CV) death, non-fatal myocardial infarction or non-fatal stroke.

About BRILINTA^® (ticagrelor) tablets

Brilinta is an oral antiplatelet treatment for ACS or prior-MI. Brilinta is a direct-acting P2Y₁₂ receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines (CPTPs) and works by inhibiting platelet activation and has been shown to reduce the rate of thrombotic CV (cardiovascular) events, such as heart attack or CV death, in patients with ACS.

Brilinta 90mg 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)). Brilinta 60mg is indicated for the treatment of patients who have suffered a heart attack at least one year prior and are at high risk of developing a further atherothrombotic event. Treatment with Brilinta 60mg may be started as continuation therapy after an initial one-year treatment with Brilinta 90mg and aspirin or other dual anti-platelet therapy.

Brilinta has been shown to reduce the rate of a combined end point of CV death, 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 percutaneous coronary intervention, it also reduces the rate of stent thrombosis.

Brilinta is a registered trademark of the AstraZeneca group.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as in infection and neuroscience. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

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Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease, ING - Infection, Neuroscience and Gastrointestinal