Have a question about the ASPREE study?
Had every ASPREE participant been followed for five years, we would have needed to wait until those enrolled in 2014, completed their time. That would make for an even longer study – the results wouldn’t be known until 2020!
You learned which arm of the trial you were in (aspirin or placebo) around the same time as publication of the main study paper in September 2018.
The study findings had been closely scrutinised by academic peers with relevant clinical expertise, as expected prior to publication in a high quality medical journal. ASPREE is the first large scale study in the world to consider the impact of disability on quality of life for older people. More information about the results can be found on the associated media release and Q&As. Additional research on the effect of aspirin on specific diseases, such as depression and cancer, will be published in future papers.
All ASPREE participants were invited to be involved in an important follow-up observational study, called ASPREE-XT (eXTension), to determine whether aspirin has a longer term effect on health, such as prevention of cancer or dementia. ASPREE-XT, which commenced in January 2018, will help also identify factors that may contribute to health and wellbeing in later years.
ASPREE was an ‘intention to treat’ study, which means that all participants, even if they were not on any study medication, were included in the final analysis. Missing or incomplete data, diluted the accuracy of the results. An ‘intention to treat’ analysis enabled researchers to test the effectiveness of aspirin in real world scenarios, such as someone developing illness or being unable to take the study medication.
By continuing with annual visits you helped us learn about changes in health with and without aspirin during the trial period.
Every phase in a clinical trial, does require approval from a Human Research Ethics Committee. Results from Phase IV studies can lead to new recommendations or withdrawal of an intervention from the market.
The 100mg dose of aspirin has blood thinning (anti-platelet) actions with low side effects from bleeding. This dose is lower than that usually taken for pain relief and for reducing fever. It is the same dose prescribed for people who need it for secondary prevention e.g. to prevent a second heart attack or stroke.
Constituents of the placebo tablets:
The placebo tablets, like the aspirin tablets, were enteric-coated.
The enteric-coating of both the placebo and aspirin tablets contained:
The ‘active’ tablet contained 100 mg of acetylsalicylic acid (aspirin).
Some prostaglandins cause fever, inflammation and pain, while other prostaglandins form a layer on the stomach wall to protect it from harsh stomach acid. Aspirin inhibits the production of prostaglandins, which will reduce fever, pain and inflammation, but it will also put the stomach at risk of this layer thinning. If the layer becomes too thin stomach acid can erode the wall of the stomach and form an ulcer.
Others side effects of aspirin are related to its action on platelets. Aspirin’s anti-platelet or blood thinning effect leads to a delay in blood clotting. This means that if you bleed and are taking aspirin, the bleeding may take longer to stop. Symptoms of this longer bleeding time may include bruises, blood in the stools (due to gastrointestinal bleeding), or in the worst case, a bleed into the brain (cerebral hemorrhage or a bleeding stroke). These adverse effects are risks. Although some people unfortunately experience side-effects, not everyone that takes aspirin will experiences adverse effects.
The balance of benefit and risks of aspirin in healthy older people was unknown prior to the ASPREE study. Your physician is the best person to give you individual health advice about whether you should or should not take daily low-dose aspirin.
For more information about aspirin click here
Aspirin belongs to a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). If you take a number of NSAIDs at the same time the side effects can be cumulative.
If you have any concerns about any medications, speak to your health provider.