NICE appraisal of clopidogrel and modified-release dipyridamole for the prevention of occlusive vascular events
NICE is currently reviewing its guidance on the use of the drugs clopidogrel and modified-release dipyridamole for the prevention of occlusive vascular events (OVEs), originally published in 2005. In draft guidance published for public consultation today (4 August), NICE has recommended the wider use of clopidogrel in people who have previously had a stroke, or who have been diagnosed with a condition called peripheral arterial disease (PAD), which puts them at high risk of stroke or heart attack.
The draft guidance recommends:
- Clopidogrel (initiated with the least costly licensed preparation) as an option for people who have had an ischaemic stroke, who have PAD or who have cardiovascular disease (CVD) in more than one vascular site (multivascular disease). Clopidogrel is only recommended as an option for people who have had a heart attack if aspirin is contraindicated or not tolerated.
- Modified-release dipyridamole plus aspirin as an option for people who have had a transient ischaemic attack (TIA). 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 only where treatment with aspirin and clopidogrel is contraindicated or not tolerated.
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 evidence of lower limb PAD. 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.
The aim of treatment is to prevent recurrent OVEs and can include the use of one or more antiplatelet agents, including aspirin, clopidogrel and modified-release dipyridamole, which work by preventing the formation of blood clots in the arteries.
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 in England and Wales and that people who have had one heart attack or stroke are at a greater risk of having another. Since the original NICE guidance was published in 2005 there have been two further studies that have looked at the use of clopidogrel and modified-release dipyridamole plus aspirin for the prevention of occlusive vascular events. Both were supportive of the conclusions in that guidance. Further, the availability of clopidogrel as a generic preparation has seen a marked fall in its price and this has meant that the Committee has been able to recommend that it now be used more widely. There is also evidence that the drugs continue to provide benefit beyond the two years previously suggested by the original guidance and this is reflected in the draft guidance published today.”
NICE's preliminary guidance is now available for public consultation on the NICE website until 25 August 2010. Feedback received during consultation may result in changes to the preliminary recommendations and will be considered by the committee at their next meeting.
Notes to Editors
About the guidance
1. The appraisal consultation document (ACD) will be available on the NICE website at http://guidance.nice.org.uk/TA/WaveR/19 from Wednesday 4 August 2010. Consultation will take place between 4 August and 25 August 2010.
2. The existing NICE guidance (technology appraisal 90) is available on the NICE website at http://guidance.nice.org.uk/TA90.
3. Clopidogrel (Plavix, Sanofi-Aventis, Bristol-Myers Squibb) 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 £5.13 for 30 days. 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.
4. 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 plus aspirin is £7.50.
5. Occlusive vascular events, including ischaemic strokes and heart attacks, occur when a blood vessel becomes blocked, usually as a result of a build-up of fatty deposit on the wall of the artery (called atherosclerosis) and the flow of blood through it is restricted. When an area of fatty deposit breaks off in one of the arteries, a chain of events is set off that can lead to blood clots forming and blocking the already narrowed artery. If the blood supply to the brain is affected, the result can be a stroke (either an ischaemic stroke if it happens for more than 24 hours, or a transient ischaemic attack (TIA) if it happens for a shorter time). If the blood supply to the heart is affected, a heart attack (or myocardial infarction - MI) can result. PAD is caused by a narrowing of the arteries in the arms or legs and people with PAD are at high risk of heart attack or stroke.
6. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.
7. 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, procedures and medical technologies within the NHS
- clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.
This page was last updated: 04 August 2010