Recently, the American Diabetes Association (ADA) published their updated Standards of Medical Care in Diabetes document and one of the major changes this year was in regards to aspirin recommendations in primary prevention patients (patients who have no prior history of cardiovascular disease such as heart attack or stroke). If you’ve heard about this change or been asked about it by your patients, you might be feeling a little confused or uncomfortable with the information. It was quite a shift from what we had been recommending!
Prior to this year’s update, the ADA recommended daily aspirin 75 to 162 mg per day for primary prevention in patients with type 1 or type 2 diabetes who were at increased cardiovascular risk.1 This included patients over 40 years of age or who had additional risk factors for cardiovascular disease like a family history of cardiovascular disease, hypertension, smoking, dyslipidemia, or albuminuria. As of now, the ADA only recommends aspirin for primary prevention in patients with diabetes who have a 10 year risk of a cardiovascular event of greater than 10%.2 The guidelines note that this likely includes men over the age of 50 and women over the age of 60 who have at least one additional risk factor for cardiovascular disease. This change comes after the publication of a meta-analysis by De Berardis, et al which was published in the British Medical Journal in 2009.3 Several large trials were evaluated in this meta-analysis including the Physicians’ Health Study, the Early Treatment of Diabetic Retinopathy Study, the Primary Prevention Project, the Women’s Health Study, the Prevention of Progression of Arterial Disease and Diabetes, and the Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes Study. The authors were looking for a difference in all cause mortality, death from cardiovascular causes, non-fatal MI, or non-fatal stroke between patients receiving aspirin versus those receiving no treatment or placebo. No significant difference in the risk of major cardiovascular events, all cause mortality, death from cardiovascular causes, risk of heart attack, or risk of stroke was found. When the sexes were separated, it was found that aspirin significantly reduced the risk of myocardial infarction in men, but no significant difference was found among women taking aspirin in regards to heart attack. The authors concluded that a clear benefit of aspirin for primary prevention of cardiovascular events in patients with diabetes has not been proven and that sex may be an important factor.
So, what now? Well, first, if one of your patients with diabetes is asking you if they should take a daily aspirin or not, you are going to need to ask some questions. This question has become more complicated than it once was.
Step One: find out if they are allergic to aspirin. It is always important to verify this first just to be safe.
Step Two: Find out if they have a history of cardiovascular disease. If they do, they are not in the primary prevention category, they are secondary prevention, and no change has been made to the recommendation for use of aspirin in those patients…aspirin 75 to 162 mg per day is still recommended for them. If a patient with cardiovascular disease is allergic to aspirin, clopidogrel (Plavix) 75 mg daily can be recommended instead.
Step Three: For those patients without cardiovascular disease, find out their age and get some basic information about them including whether or not they have a family history of cardiovascular disease, whether or not they have hypertension, whether or not they smoke, whether or not they have dyslipidemia, and whether or not they have albuminuria. Some of this information the patient may be able to supply to you and some may require consultation with their physician.
Step Four: For men over 50 and women over 60 (Patient younger than this? Skip to Step Five.) who also have any one of the above cardiovascular risk factors, the current ADA guidelines suggest that aspirin 75 to 162 mg daily may still be an appropriate recommendation for primary prevention.
Step Five: For younger patients, calculate their risk of having a cardiovascular event within the next 10 years. You can get to an online risk calculator at http://hp2010.nhlbihin.net/atpIII/calculator.asp?usertype=prof (this calculator will require you to know the patient’s age, gender, whether they are a smoker or not, their systolic blood pressure and if they are being treated for hypertension, their total cholesterol, and their high density lipoprotein (or HDL) cholesterol measurement. If they have a risk over 10% of having a cardiovascular event, then the ADA recommends that they receive aspiring 75 to 162 mg per day as a primary prevention strategy, too.
Step Six (Last, but definitely not least and do not leave it out!): Look for contraindications and reasons not to recommend aspirin…Aspirin is still not recommended for patients under age 30 and is contraindicated in those less than 21 years of age. Be aware, the ADA guidelines are just that, guidelines. They cannot replace the clinical judgment that a patient’s pharmacist and doctor are able to supply when deciding whether or not to recommend daily aspirin for primary prevention. Remember that each patient is special. If they have a history of bleeding (such as from peptic ulcer disease) or if they are already taking a blood thinner like warfarin (Coumadin), daily aspirin for primary prevention may very well not be appropriate in that patient.
You, as the patient’s pharmacist, are in an ideal position to determine if aspirin is appropriate for them. You may need to consult their physician and that is ok. In fact, it is better than ok, that is great! It gives you an opportunity to become and even more engaged part of your patient’s healthcare team. Keep an eye out for changing recommendations regarding aspirin for primary prevention. Two trials in particular will likely tell us more about this in the years to come. They are A Study of Cardiovascular Events in Diabetes (ASCEND) and the Aspirin and Simvastatin Combination for CV Events Prevention Trial in Diabetes (ACCEPT-D). So keep your ear to the ground about this subject and keep being a great frontline information source for your patients and advocate for their health!
1. American Diabetes Association. Standards of Medical Care in Diabetes-2009. Diabetes Care 2009; 32 (Supplement 1): S13-S61.
2. American Diabetes Association. Standards of Medical Care in Diabetes-2010. Diabetes Care 2010;33(Supplement 1):S11-S61.
3. De Berardis G, Sacco M, Strippoli GFM, et al. Aspirin for primary prevention of cardiovascular events in people with diabetes: meta-analysis of randomised controlled trials. BMJ. 2009;339:b4531.