17 May 2011
Clopidogrel* alone is now recommended by NICE with no limits on duration of treatment in people who have had an ischaemic stroke. Modified-release (MR) dipyridamole plus aspirin is now recommended after an ischaemic stroke only if clopidogrel is contraindicated or not tolerated. This and other changes in NICE guidance on clopidogrel and MR dipyridamole for the prevention of occlusive vascular events have been introduced in technology appraisal guidance 210, which replaces the NICE guidance issued in 2005.
*Treatment with clopidogrel should be started with the least costly licensed preparation. In current practice, this means generic clopidogrel.
What are the implications of the new guidance?
Health professionals should follow this guidance for people who have had an occlusive vascular event or who have established peripheral arterial disease. Here is our summary of the practical implications of these changes:
After an ischaemic stroke:
- Clopidogrel alone is now recommended, with no specified limit on duration of treatment
- MR dipyridamole plus aspirin is now recommended after an ischaemic stroke only if clopidogrel is contraindicated or not tolerated, but treatment is no longer limited to two years
- MR dipyridamole alone is recommended after an ischaemic stroke only if aspirin or clopidogrel cannot be used as above because they are contraindicated or not tolerated, again with no limit on duration of treatment.
After a transient ischaemic attack (TIA):
- Treatment with MR dipyridamole plus aspirin is still recommended for people who have had a TIA, but now there is no recommended limit on the duration of treatment
- MR dipyridamole monotherapy is recommended after TIA only if aspirin is contraindicated or not tolerated, again with no limit on duration of treatment
- No recommendations are made about the use of clopidogrel after a TIA because it is not licensed for this indication.
After a myocardial infarction (MI):
- Recommendations about aspirin as the treatment of choice post MI is not affected by this new guidance
- Clopidogrel is recommended for people who have had an MI, only if aspirin is contraindicated or not tolerated. This guidance should be considered alongside existing NICE guidance, which gives details on the use of clopidogrel in combination with aspirin in people who have had an MI (see CG48), and in people with unstable angina or non-ST-segment-elevation MI (NSTEMI, see CG94).
Peripheral arterial disease (PAD) or multivascular disease:
- Clopidogrel alone is now recommended for patients with PAD or multivascular disease.
Treatment with clopidogrel should be started with the least costly licensed preparation. In current practice, this means generic clopidogrel. Although not discussed in the guidance, aspirin monotherapy would seem to be the logical choice if both clopidogrel and MR dipyridamole were contraindicated or not tolerated.
People currently receiving clopidogrel or MR dipyridamole, either with or without aspirin, outside the revised recommendations should have the option to continue treatment until they and their clinicians consider it appropriate to stop.
This guidance does not apply to people with atrial fibrillation (AF). NICE guidance on prophylaxis of stroke in people with AF is given in CG36. More information on managing AF can be found in the NPC e-learning materials on atrial fibrillation. It also does not apply to those who need treatment to prevent occlusive events after coronary revascularisation or carotid artery procedures.
What were the reasons for this change in guidance?
One of the key drivers underpinning the change in guidance since the publication of the previous NICE guidance in 2005 (TA90), has been the availability of generic formulations of clopidogrel. Consequently, for people who have had an ischaemic stroke, the cost effectiveness of treatment changed depending on whether the branded or generic price of clopidogrel was used. Clopidogrel is not licensed for the treatment of TIAs, and is therefore not recommended by NICE for use in this patient population.
In addition, since the publication of TA90, the ESPRIT trial has been published. This provided evidence of a continued treatment effect from aspirin plus MR dipyridamole beyond the two years recommended in TA90. The revised guidance has taken this into account and no longer recommends a maximum duration of treatment.
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