New SIGN Guidelines On Stroke Upgrade Plavix® (clopidogrel) Recommendation For Secondary Stroke Prevention
The Scottish Intercollegiate Guidelines Network (SIGN) have issued new guidelines for the treatment of stroke, giving clopidogrel (Plavix®) a Grade A recommendation as a monotherapy alternative to the combination of aspirin and dipyridamole in the secondary prevention of vascular events.(1)
New data has been published demonstrating the efficacy of clopidogrel in this indication since the previous guidelines were produced, such as... PRoFESS*, the largest ever trial of its kind in stroke. With the publication of these guidelines, Scotland has again shown itself to be leading the way in terms of using the most recent clinical data to inform the guidance issued for its clinicians.
Under the previous SIGN guidelines, aspirin and dipyridamole was the recommended 1st-line treatment for the secondary prevention of stroke, with clopidogrel only mentioned as a good practice point.(2) The new guidelines recommend that clopidogrel is considered as an alternative to the combination of aspirin and dipyridamole after someone has had a, ischaemic stroke, for the secondary prevention of vascular events. Both treatment options have Grade A status in recognition of the body of clinical evidence supporting their use in this indication.
Chest, Heart & Stroke Scotland Chief Executive David Clark said, "We very much welcome the new guidelines, but we must make sure that the resources are made available to provide these treatments, and that the guidelines are put into practice so that all potential Scottish stroke patients benefit. We also need to improve awareness about the signs and symptoms of a stroke and to drive home the message that stroke is a medical emergency - we are already working with the NHS through our FAST campaign to achieve this."
Stroke is the 3rd largest cause of death and the largest cause of severe disability in Scotland, as it is UK-wide.(3,4) There are an estimated 100,000 stroke survivors currently living in Scotland.(4)
The National Institute for Health and Clinical Excellence (NICE) published their most recent clinical guidelines on stroke in July 2008 (prior to the publication of the PRoFESS data in August) and are currently revising their Technology Appraisal on clopidogrel and dipyridamole for use in vascular disease (expected in 2010).(5)
Clopidogrel has been prescribed for over 10 years in a broad range of atherothrombotic patients, amongst whom it has been shown to provide early and long-term protection against future vascular events. Clopidogrel has a well-known safety and efficacy profile.(6-10)
Notes:
*PRoFESS: Prevention Regimen For Effectively avoiding Second Strokes11
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT : SAN) and in New York (NYSE : SNY).
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life.
Plavix® (clopidogrel) is manufactured by sanofi-aventis and Bristol-Myers Squibb.
References:
1 Scottish Intercollegiate Guidelines Network (SIGN), Management of patients with Stroke or TIA: assessment, investigation, immediate management and secondary prevention (SIGN 108) (2008)
2 Scottish Intercollegiate Guidelines Network (SIGN), Management of patients with Stroke: Rehabilitation, Prevention and Management of Complications, and Discharge Planning (SIGN 64) (2002)
3 Department of Health website, http://www.dh.gov.uk/en/healthcare/nationalserviceframeworks/stroke/index.htm (last accessed December 11th 2008)
4 The Stroke Association, http://www.stroke.org.uk/in_your_area/scotland/index.html (last accessed 12th December 2008)
5 National Institute for Health and Clinical Excellence (NICE), Clopidogrel and dipyridamole for the prevention of artherosclerotic events (Technology Appraisal 90). (May 2005)
6 CAPRIE Steering Committee. A randomised, blinded trial of Clopidogrel versus Aspirin in Patients at Risk of Ischaemic Events (CAPRIE). Lancet 1996; 348: 1329-1339.
7 The Clopidogrel in Unstable angina to prevent Recurrent Events trial investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. NEJM 2001; 345: 494-502.
8 COMMIT (Clopidogrel and Metoprolol in Myocardial Infarction Trial) collaborative group. Addition of clopidogrel to aspirin in 45,852 patients with acute myocardial infarction: randomised placebo-controlled trial. Lancet 2005; 366: 1607-1621.
9 Sabatine MS et al. Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation. NEJM 2005; 352: 1179-1189.
10 Yusuf S et al. Early and late effects of clopidogrel in patients with acute coronary syndromes. Circulation 2003; 107: 966-972.
11 PRoFESS Study Group. Aspirin and Extended-Release Dipyridamole versus Clopidogrel for Recurrent Stroke. NEJM 2008; 359 1-14
Sources:
Caroline Almeida
Bristol-Myers Squibb
Jeannine Nolan
sanofi-aventis
New data has been published demonstrating the efficacy of clopidogrel in this indication since the previous guidelines were produced, such as... PRoFESS*, the largest ever trial of its kind in stroke. With the publication of these guidelines, Scotland has again shown itself to be leading the way in terms of using the most recent clinical data to inform the guidance issued for its clinicians.
Under the previous SIGN guidelines, aspirin and dipyridamole was the recommended 1st-line treatment for the secondary prevention of stroke, with clopidogrel only mentioned as a good practice point.(2) The new guidelines recommend that clopidogrel is considered as an alternative to the combination of aspirin and dipyridamole after someone has had a, ischaemic stroke, for the secondary prevention of vascular events. Both treatment options have Grade A status in recognition of the body of clinical evidence supporting their use in this indication.
Chest, Heart & Stroke Scotland Chief Executive David Clark said, "We very much welcome the new guidelines, but we must make sure that the resources are made available to provide these treatments, and that the guidelines are put into practice so that all potential Scottish stroke patients benefit. We also need to improve awareness about the signs and symptoms of a stroke and to drive home the message that stroke is a medical emergency - we are already working with the NHS through our FAST campaign to achieve this."
Stroke is the 3rd largest cause of death and the largest cause of severe disability in Scotland, as it is UK-wide.(3,4) There are an estimated 100,000 stroke survivors currently living in Scotland.(4)
The National Institute for Health and Clinical Excellence (NICE) published their most recent clinical guidelines on stroke in July 2008 (prior to the publication of the PRoFESS data in August) and are currently revising their Technology Appraisal on clopidogrel and dipyridamole for use in vascular disease (expected in 2010).(5)
Clopidogrel has been prescribed for over 10 years in a broad range of atherothrombotic patients, amongst whom it has been shown to provide early and long-term protection against future vascular events. Clopidogrel has a well-known safety and efficacy profile.(6-10)
Notes:
*PRoFESS: Prevention Regimen For Effectively avoiding Second Strokes11
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT : SAN) and in New York (NYSE : SNY).
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life.
Plavix® (clopidogrel) is manufactured by sanofi-aventis and Bristol-Myers Squibb.
References:
1 Scottish Intercollegiate Guidelines Network (SIGN), Management of patients with Stroke or TIA: assessment, investigation, immediate management and secondary prevention (SIGN 108) (2008)
2 Scottish Intercollegiate Guidelines Network (SIGN), Management of patients with Stroke: Rehabilitation, Prevention and Management of Complications, and Discharge Planning (SIGN 64) (2002)
3 Department of Health website, http://www.dh.gov.uk/en/healthcare/nationalserviceframeworks/stroke/index.htm (last accessed December 11th 2008)
4 The Stroke Association, http://www.stroke.org.uk/in_your_area/scotland/index.html (last accessed 12th December 2008)
5 National Institute for Health and Clinical Excellence (NICE), Clopidogrel and dipyridamole for the prevention of artherosclerotic events (Technology Appraisal 90). (May 2005)
6 CAPRIE Steering Committee. A randomised, blinded trial of Clopidogrel versus Aspirin in Patients at Risk of Ischaemic Events (CAPRIE). Lancet 1996; 348: 1329-1339.
7 The Clopidogrel in Unstable angina to prevent Recurrent Events trial investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. NEJM 2001; 345: 494-502.
8 COMMIT (Clopidogrel and Metoprolol in Myocardial Infarction Trial) collaborative group. Addition of clopidogrel to aspirin in 45,852 patients with acute myocardial infarction: randomised placebo-controlled trial. Lancet 2005; 366: 1607-1621.
9 Sabatine MS et al. Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation. NEJM 2005; 352: 1179-1189.
10 Yusuf S et al. Early and late effects of clopidogrel in patients with acute coronary syndromes. Circulation 2003; 107: 966-972.
11 PRoFESS Study Group. Aspirin and Extended-Release Dipyridamole versus Clopidogrel for Recurrent Stroke. NEJM 2008; 359 1-14
Sources:
Caroline Almeida
Bristol-Myers Squibb
Jeannine Nolan
sanofi-aventis