Transcript Clopidogrel and Aspirin versus Aspirin Alone for the

A Review of –
Clopidogrel and Aspirin versus
Aspirin Alone for the Prevention
of Atherothrombotic Events
Ted Williams
Pharm D Candidate
Monday Lab – Group D
Clopidogrel & Aspirin - When
should pharmacist intervene?
– Joe, 47 yo male Diabetic
– Betty, 68 yo female with a hx of Angina
– Phil, 76 yo male 2 yrs post-PCI
– Jean, 57 yo female hospital discharge orders
for Clopidogrel, ASA, Metoprolol Succinate,
Lisinopril, Lipitor, Nitroglycerin SL,
oxycodone, Hydrocodone/APAP
Study Objective
• Determine if Clopidogrel + ASA 81mg
decreases risk of CV Events vs. ASA
81mg alone.
Methods – for completeness
• Study Design
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Multicenter, randomized, double-blind, placebo-controlled (n=15,603)
Executed by Cleveland Clinic Cardiovascular Coordination Center
Sponsored by Sanofi-Aventis & Bristol-Myers (Plavix Patent holder)
Plavix + ASA 81mg vs. Placebo + ASA 81mg
• Inclusions
– >45yrs
– Established CVD
– Multiple risk factors for CVD
• Efficacy
– Primary end point of MI, Stroke, or Death due to CV event/hemorrhage
– Secondary endpoint incidence of CV events or hospitalization for CAD
related events
• Safety
– Pearson chi-square test
Efficacy Findings
Clopidogrel and Aspirin versus Aspirin Alone for the Prevention of Atherothrombotic Events. (NEJM 2007;354:1706-17)
Safety Findings
• Moderate Bleeding significantly increased
• GUSTO Moderate: bleeding that led to transfusion, but
did not meet “severe” criteria
Clopidogrel and Aspirin versus Aspirin Alone for the Prevention of Atherothrombotic Events. (NEJM 2007;354:1706-17)
Clopidogrel & Aspirin –
When should pharmacists intervene?
– Joe, 47 yo male diabetic
• Diabetics should be on ASA 81mg (ADA)
• Any Clopidogrel prescription should raise a question
– Betty, 68 yo female with a hx of Angina
• Dual therapy not indicated
• Investigate with patient & MD
– Phil, 76 yo male 2 yrs post-PCI
• Dual therapy only recommended for 1 year (AHA/ACC)
• Investigate
– Jean, 57 yo female hospital discharge orders for
Clopidogrel, ASA, Metoprolol Succinate, Lisinopril, Lipitor,
Nitroglycerin SL, oxycodone, Hydrocodone/APAP
• Sounds post-PCI to me…
• No intervention, dual therapy indicated (AHA/ACC)
References
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Bhatt, B., Fox, D., Hacke, W., et al, (2007) Clopidogrel and Aspirin versus Aspirin
Alone for the Prevention of Atherothrombotic Events. NEJM 2007;354:1706-17.
Retrieved from http://content.nejm.org/cgi/content/full/354/16/1706 on 01/21/2007
The GUSTO Investigators. An international randomized trial comparing four
thrombolytic strategies for acute myocardial infarction. N Engl J Med 1993;329:67382. Retrieved from http://content.nejm.org/cgi/content/full/329/10/673
Smith, S., Allen, J., Blair, S., AHA/ACC Guidelines for Secondary Prevention for
Patients With Coronary and Other Atherosclerotic Vascular Disease: 2006 Update .
Retrieved from http://circ.ahajournals.org/cgi/content/full/113/19/2363
Standards of Medical Care in Diabetes—2007 AMERICAN DIABETES
ASSOCIATION Retrieved from
http://care.diabetesjournals.org/cgi/reprint/30/suppl_1/S4