FDA against aspirin for primary prevention

FDA with consumer statement about aspirin for primary prevention of heart disease.  they comment:
 
Use of Aspirin for Primary Prevention of Heart Attack and Stroke
[05/02/2014] Cardiovascular disease, including heart disease and stroke, affects tens of millions of people in the United States.  Consumers and patients who do not suffer from cardiovascular disease sometimes consider taking aspirin to reduce the possibility of having a heart attack or stroke.  Reducing the possibility of having a first heart attack or stroke is called primary prevention.  The FDA has reviewed the available data and does not believe the evidence supports the general use of aspirin for primary prevention of a heart attack or stroke.  In fact, there are serious risks associated with the use of aspirin, including increased risk of bleeding in the stomach and brain, in situations where the benefit of aspirin for primary prevention has not been established.
The available evidence supports the use of aspirin for preventing another heart attack or stroke in patients who have cardiovascular disease or who have already had a heart attack or stroke. Reducing the risk of additional heart attacks or strokes is known as secondary prevention. In patients who have had a cardiovascular event, the known benefits of aspirin for secondary prevention outweigh the risk of bleeding.
FDA is committed to reviewing any data supporting new medicines and new uses to improve the health of the American public.
 
 
This comment was in Physician’s First Watch by Larry Husten, noting that this was in response to FDA rejecting Bayer’s request for primary prevention indication:
 
Aspirin shouldn't be marketed for primary prevention of heart attack or stroke, the FDA has announced. The statement follows the agency's rejection on Friday of Bayer Healthcare's decade-old petition requesting approval of a primary prevention indication.
 
i would just add that there may be other, nonvascular benefits from aspirin, esp in some cancer prevention. i have sent out several blogs in the past 6 months showing aspirin is assoc with decreased cancer incidence and mortality overall, and some interesting data specifically on decreasing prostate, colon, breast, ovarian cancer and even prolonging life in patients with metastatic cancer (i can resend these if you want.  let me know). so, though the primary indication for aspirin, and the basis of the above FDA response, is around vascular disease (and i agree that the data for primary prevention is not good), there may be other important benefits (also one i sent out about dementia). most of this data is secondary analysis of RCTs, so is not completely statistically rigorous.
 

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