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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
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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 • 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, MetoprololSuccinate, Lisinopril, Lipitor, Nitroglycerin SL, oxycodone, Hydrocodone/APAP • Sounds post-PCI to me… • No intervention, dual therapy indicated (AHA/ACC)
References • 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;329:673-82. 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