The US Food and Drug Administration’s (FDA) decision not to recommend aspirin for primary prevention due to a lack of scientific evidence, adds further support for the ASPREE study.
In a statement issued on their website, the FDA reported that the potential benefits of aspirin had not yet been established against known risks, such as bleeding, in people without cardiovascular disease.
The US authority added that it was awaiting the results of several clinical trials, which “…may provide new evidence that could be the basis for changing the current uses (indications) for aspirin.”
ASPREE (ASPirin in Reducing Events in the Elderly) is the largest international clinical trial to weigh the potential benefits of aspirin against the risks for primary prevention of disease in healthy older people.
In addition to cardiovascular disease, the ASPREE study will determine the potential effect of daily low dose aspirin on dementia and certain cancers.
Older people are at higher risk of having a heart attack, stroke, dementia and cancer but they may also be more likely to experience side effects of aspirin.
Results of the ASPREE study should be known by 2018.
Anyone considering taking daily aspirin or changing their aspirin regime should always speak to their GP first.
FDA issued the statement after turning down a request from Bayer HealthCare to market aspirin for primary prevention.(http://www.fda.gov/drugs/resourcesforyou/consumers/ucm390574.htm)