A Review of Clopidogrel and Aspirin versus Aspirin Alone for the Prevention of Atherothrombotic Even

1
A Review of Clopidogrel and Aspirin versus
Aspirin Alone for the Prevention of
Atherothrombotic Events

• Ted Williams
• Pharm D Candidate
• Monday Lab Group D

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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

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Study Objective

• Determine if Clopidogrel ASA 81mg decreases
  risk of CV Events vs. ASA 81mg alone.

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Methods for completeness

• Study Design
• Multicenter, randomized, double-blind,
  placebo-controlled (n15,603)
• Executed by Cleveland Clinic Cardiovascular
  Coordination Center
• Sponsored by Sanofi-Aventis Bristol-Myers
  (Plavix Patent holder)
• Plavix ASA 81mg vs. Placebo ASA 81mg
• Inclusions
• gt45yrs
• 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

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Efficacy Findings
Clopidogrel and Aspirin versus Aspirin Alone for
the Prevention of Atherothrombotic Events. (NEJM
20073541706-17)
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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
20073541706-17)
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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)

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References

• Bhatt, B., Fox, D., Hacke, W., et al, (2007)
  Clopidogrel and Aspirin versus Aspirin Alone for
  the Prevention of Atherothrombotic Events. NEJM
  20073541706-17. Retrieved from
  http//content.nejm.org/cgi/content/full/354/16/17
  06 on 01/21/2007
• The GUSTO Investigators. An international
  randomized trial comparing four thrombolytic
  strategies for acute myocardial infarction. N
  Engl J Med 1993329673-82. Retrieved from
  http//content.nejm.org/cgi/content/full/329/10/67
  3
• 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/113/1
  9/2363
• Standards of Medical Care in Diabetes2007
  AMERICAN DIABETES ASSOCIATION Retrieved from
  http//care.diabetesjournals.org/cgi/reprint/30/su
  ppl_1/S4