NICE publishes final guidance on clopidogrel and modified-release dipyridamole for the prevention of occlusive vascular events

NICE has today (15 December) published final guidance on the use of clopidogrel and modified-release dipyridamole for the prevention of occlusive vascular events (ischaemic stroke, transient ischaemic attack or heart attack). The guidance is for people at high risk of occlusive vascular events because they have previously had an ischaemic stroke, a heart attack, a transient ischaemic attack, or have been diagnosed with a condition called peripheral arterial disease. The guidance also makes specific recommendations for people who have cardiovascular disease in more than one vascular site (multivascular disease).

The guidance, which updates previous NICE guidance published in 2005, recommends:

  • Clopidogrel (initiated with the least costly licensed preparation) as an option for people who have had an ischaemic stroke, who have peripheral arterial disease or who have multivascular disease. Clopidogrel is only recommended as an option for people who have had a heart attack if they cannot take aspirin.
  • Modified-release dipyridamole plus aspirin as an option for people who have had a transient ischaemic attack. For people who have had an ischaemic stroke, modified-release dipyridamole plus aspirin should only be used where clopidogrel is contraindicated or not tolerated.
  • Modified-release dipyridamole alone as an option for people who have had an ischaemic stroke or a transient ischaemic attack, only where treatment with aspirin and clopidogrel is contraindicated or not tolerated.

Professor Peter Littlejohns, Clinical and Public Health Director at NICE, said: "We know that heart attacks and strokes are some of the biggest killers and causes of disability, and that people who have had one heart attack or stroke are at a greater risk of having another. In the UK, it is estimated that each year 98,000 people have a first ischaemic stroke, as many as 65,000 people have a transient ischaemic attack and 146,000 have a heart attack. In addition, it is estimated that approximately 850,000 people aged 55-75 years have lower limb peripheral arterial disease, of whom 5% have symptoms. Today's guidance for clopidogrel and modified release dipyridamole therefore has the potential to have a significant impact on the treatment of many thousands of patients in England and Wales."

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Notes to Editors

About the guidance

1. The NICE guidance on the use of clopidogrel and modified-release dipyridamole for the prevention of occlusive vascular events is available on the NICE website from 15 December 2010.

2. Clopidogrel is an irreversible adenosine diphosphate-receptor antagonist with antiplatelet properties. It has a marketing authorisation for the prevention of atherothrombotic events in adults who have had a MI (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. The cost of generic clopidogrel is £3.40 for 30 days. The cost of branded clopidogrel (Plavix, Sanofi-Aventis, Bristol-Myers Squibb) for 30 days at a dose of 75 mg daily is £35.64. Clopidogrel is not licensed for the treatment/prevention of transient ischaemic attacks and therefore recommendations could not be made about the use of clopidogrel in this patient population.

3. Modified-release dipyridamole (Persantin Retard and Asasantin Retard [combined with aspirin], Boehringer Ingelheim) has both antiplatelet and vasodilating properties. It has a marketing authorisation for the secondary prevention of ischaemic stroke and transient ischaemic attacks, either alone or in conjunction with aspirin. The 30 day cost of treatment with modified-release dipyridamole is £7.50.

4. In the UK, it is estimated that each year 98,000 people have a first ischaemic stroke, as many as 65,000 people have a TIA and 146,000 have a heart attack (or myocardial infarction - MI). In addition, it is estimated that approximately 850,000 people aged 55-75 years have lower limb PAD of whom 5% have symptoms. Stroke and MI are associated with a high morbidity and mortality. Some 30% of people die from their first MI. After a stroke, approximately 23% of people die within 30 days and the overall 3 year survival rate is only 30-40%. Stroke is also the leading cause of disability in the UK, with about 25-30% of people who survive a stroke remaining permanently disabled.

About occlusive vascular events

5. An occlusive vascular event can happen when a person has a build-up of fatty deposits on the walls of their arteries. The arteries become narrow and blood cannot flow properly - this is called vascular disease.

6. If a narrowed part of an artery is damaged, a blood clot can form. This blood clot can block the artery, or travel through the blood vessels to another part of the body and block the blood flow there. When an artery is blocked in this way it is known as an occlusive vascular event.

7. There are different types of occlusive vascular event depending on where the blockage occurs. If the blood supply to the brain is affected, the result can be a stroke (either an ischaemic stroke, or if it happens for only a short time, a transient ischaemic attack). If the blood supply to the heart is affected, a heart attack can result. Peripheral arterial disease (PAD) is caused by a narrowing of the arteries in the arms or legs and people with the disease are at high risk of heart attack or stroke.

About NICE

8. 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.

9. NICE produces guidance in three areas of health:

  • public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
  • health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
  • clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS

10. NICE produces standards for patient care:

  • quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
  • Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

11. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.

This page was last updated: 15 December 2010