FDA approved indications for aspirin

The US Food and Drug Administration (FDA) has approved the use of aspirin to reduce the risk of heart attack and stroke in adult men and women who have had a previous heart attack or ischemic stroke, or who are at high risk for these events (Physician's Desk Reference, 2004). The high-risk patient may have any of the following comorbid conditions:
 

• Previous TIA
• Chest pain (stable angina)
• History of certain heart procedures, such as angioplasty or bypass

Aspirin therapy may be considered as a secondary prevention strategy in men with diabetes and women who have evidence of large vessel disease. This includes men with diabetes and women with a history of MI, vascular bypass procedure, stroke or TIA, peripheral vascular disease, claudication, and/or angina (American Diabetes Association, 2002).

In addition to being used in secondary prevention, aspirin therapy may be considered as a primary prevention strategy in men and women with type 1 or type 2 diabetes who are at high risk for CV. This recommendation includes diabetic patients with one or more of the following risk factors (American Diabetes Association, 2002):

• A family history of CHD
• Cigarette smoking
• Hypertension
• Obesity (body mass index [BMI]>27.3 kg/m2 in women, >27.8 kg/m² in men)
• Albuminuria (micro or macro)
• Lipids:
  – Total cholesterol >200 mg/dL
  – LDL cholesterol >100 mg/dL
  – High density lipoprotein (HDL) cholesterol <45 mg/dL for men or <55 mg/dL for women
  – Triglycerides >200 mg/dL
• Age >30 years (the use of aspirin has not been studied in diabetic individuals under 30 years of age)

An aspirin regimen is not appropriate for everyone, nor is it sufficient for patients with PAD alone. A randomized, controlled trial evaluated the effect of aspirin (75 mg/d),  clopidogrel (75 mg/d), and then both drugs on several platelet function indices in patients with PAD (n=20). There was a significant (P=0.0001) decrease in adenosine diphosphate (ADP)-induced aggregation after clopidogrel but not after taking aspirin. In PAD, clopidogrel is a more potent inhibitor of ADP-induced platelet activation than aspirin; combination therapy is more effective than clopidogrel or aspirin monotherapy (Jagroop, 2004).

In the CAPRIE (Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events) trial, clopidogrel was shown to be superior to aspirin in reducing cardiovascular and cerebrovascular ischemic events in patients with PAD (Figure 1) (CAPRIE Steering Committee, 1996).  Trials of dipyridamole monotherapy have not shown antithrombotic efficacy in PAD, and results from trials of dipyridamole and aspirin have been inconsistent (Hiatt, 2002).

Aspirin is contraindicated in patients with aspirin allergy, bleeding tendency, anticoagulant therapy, recent gastrointestinal bleeding, and clinically active hepatic disease (Physician's Desk Reference, 2004).

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