New NICE guidance recommends "clot-busting" drug to treat acute coronary syndromes
The National Institute for Health and Care Excellence (NICE) has today (26 October) published final guidance to the NHS in England and Wales recommending ticagrelor (Brilique, Astrazeneca), in combination with aspirin and for up to 12 months, as an option to treat adults with acute coronary syndromes (ACS).
Acute coronary syndromes are caused when a blood clot blocks one of the large blood vessels that carry oxygen-rich blood to the heart. The blockage (ischaemia) stops blood reaching part of the heart muscle and the part of the heart affected can become permanently damaged. Where the blood supply to the heart is blocked but there is no evidence of actual damage to the heart muscle, the clinical syndrome is described as unstable angina. ST-segment-elevation myocardial infarction (STEMI) and Non-ST-segment-elevation myocardial infarction (NSTEMI) - the names come from the pattern seen on an ECG, which measures the rhythm and electrical activity of the heart - happens when the ischaemia results in damage to the heart muscle. Every year around 200,000 people are diagnosed with ACS in England, of whom around three quarters have unstable angina or NSTEMI.
Ticagrelor belongs to a class of drugs called anti-platelets. These work by reducing or preventing the formation of blood clots, so that blood flow to the heart muscle can be maintained to prevent further damage. Ticagrelor is licensed for the treatment of people with ACS who are managed medically or who are to undergo percutaneous coronary intervention (PCI) - a procedure to widen narrowed arteries in the heart.
The NICE guidance recommends the use of ticagrelor, in combination with aspirin, as a treatment option in people with STEMI who are to undergo PCI and in people with NSTEMI. It is also recommended as a treatment option for people admitted to hospital with unstable angina, which is defined as changes on electrocardiogram suggestive of ischaemia, and who have one characteristic associated with cardiovascular diseasei.
Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: "The evidence shows that ticagrelor, in combination with aspirin, is effective at reducing MI and deaths from cardiovascular causes. Today's guidance, in recommending the use of ticagrelor where clinically appropriate, is an affirmation of that effectiveness and good news for patients with ACS, wherever they live in England and Wales, because it increases the number of treatment options available to them."
Notes to Editors
About the guidance
1. Please contact the press office for an embargoed copy of the guidance, which will be available on the NICE website at www.nice.org.uk/guidance/TA236 from Wednesday, 26 October.
2. Ticagrelor (Brilique, AstraZeneca) is an oral reversibly bound antagonist of the P2Y12 adenosine diphosphate (ADP) receptor which inhibits platelets aggregation and therefore thrombus formation in atherosclerotic disease. The summary of product characteristics (SPC) states that ticagrelor, co-administered with acetylsalicylic acid (aspirin, ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (ACS) defined as people with, ST-segment-elevation MI (STEMI), non-ST-segment-elevation MI (NSTEMI) or unstable angina. Patients may be managed medically or revascularised with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
3. According to the SPC, treatment should be initiated with a single 180 mg (2 tablets of 90 mg) loading dose of ticagrelor and then continued at 90 mg twice daily for up to 12 months. Patients taking ticagrelor should also take low-dose aspirin daily, unless specifically contraindicated. Following an initial dose of aspirin, ticagrelor should be taken daily with a maintenance dose of aspirin of 75-150 mg.
4. The manufacturer stated in its submission that the cost of 90 mg tablets of ticagrelor is £54.60 for a pack of 56 tablets (28 days). Costs may vary in different settings because of procurement discounts.
5. Current NICE guidance (TA182) recommends prasugrel as an option for preventing atherothrombotic events in people with ACS having PCI, only when immediate primary PCI for STEMI is necessary, or stent thrombosis has occurred during treatment with clopidogrel, or the patient has diabetes.
6. NICE clinical guideline 94 (Unstable angina and NSTEMI) recommends that aspirin should be offered as soon as possible to all patients and continued indefinitely unless contraindicated by bleeding risk or aspirin hypersensitivity. For patients with aspirin hypersensitivity, clopidogrel monotherapy should be considered as an alternative. For people with increased risk of mortality and no contraindications who may undergo PCI within 24 hours of admission to hospital, clopidogrel in combination with low-dose aspirin for 12 months after the most recent acute episode of NSTEMI ACS is recommended. Thereafter, standard care, including treatment with low-dose aspirin is recommended.
i. Age 60 years or older, previous MI or previous coronary artery bypass grafting (CABG), coronary artery disease with stenosis (narrowing) of 50% or more in at least two vessels, previous ischaemic stroke, previous transient ischaemic attack, carotid stenosis of at least 50%, or cerebral revascularisation, diabetes, peripheral arterial disease, or chronic renal dysfunction.
6. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health
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This page was last updated: 25 October 2011