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Latest research the ‘death knell’ for aspirin use as primary prevention
More results from the landmark ASPREE trial have shown the harms continue to outweigh the potential benefits.
The latest study to analyse data from the Aspirin in Reducing Events in the Elderly (ASPREE) trial has found prolonged daily aspirin use increases the risk of gastrointestinal bleeding by at least 60% in people aged 70 and older.
It recorded 264 incidents of major gastrointestinal bleeding – a known side-effect of aspirin – in 19,114 participants over almost five years. Of the 264 incidents of both upper- and lower-gastrointestinal bleeding, 162 occurred in those taking aspirin daily and 102 in the placebo group.
Study co-author Professor Mark Nelson, a GP and Research Fellow at the University of Tasmania, told newsGP there is a strong safety concern related to prolonged use of aspirin as a primary preventive measure among people aged 70 and older.
‘ASCEND, ASPREE and ARRIVE have really put the death knell in the use of aspirin for primary prevention,’ he said.
‘We regularly demonstrate bleeding risk without benefit, especially in the group that we’re dealing with – the aged – where the community level of gastrointestinal bleeding is relatively high compared to middle-aged populations.
‘If somebody comes in and asks “Should I be taking aspirin?”, if they don’t have a clear clinical indication for its use, then the general recommendation should probably be no.’
The Murdoch University-led research is the largest study to investigate bleeding in older people as part of a randomised controlled trial, and involved half the participants taking a placebo and the other half a daily low dose (100 mg) of aspirin.
The international team of researchers, led by gastroenterologist and clinical epidemiologist Dr Suzanne Mahady from Murdoch’s School of Public Health and Preventive Medicine, found the risk of gastrointestinal bleeding requiring hospitalisation, blood transfusions or resulting in death increased by around 60% with daily aspirin use.
The researchers also found risk of gastrointestinal bleeding increases significantly with age, while smoking, hypertension, obesity, chronic kidney disease and the use of anti-inflammatory drugs were also found to increase bleeding risk. The combination of these risk factors in association with aspirin put people at high risk of complications.
Crucially, previous research has also shown that aspirin does not reduce heart attacks or strokes in otherwise healthy older individuals.
Professor Nelson said as ASPREE’s data has been generated in Australian general practice, the results it produces are reliably implementable into general practice advice for actual patients.
‘The onus is that if you’re giving medications to a well population, you need to be very sure that the likely benefits … significantly outweigh the harms,’ he said.
However, the results do not apply to those with existing conditions such as a previous heart attack, angina or stroke, where aspirin is recommended as a valuable preventive drug.
‘Whenever we [discuss ASPREE], we also have to give the message that for those who are on secondary prevention, there’s level one evidence that they should be on aspirin, as the benefits outweigh the likely harms,’ Professor Nelson said.
‘But ASPREE wasn’t looking at that population; it was just looking at the walk-in … elderly patient that we see regularly in our practice.’
According to Dr Mahady, the new data generated by this latest research can be used to help patients and clinicians make informed decisions about the use of aspirin.
‘We know that the most common side-effect of aspirin is bleeding, and that older people are at higher risk, but until now we haven’t been able to accurately quantify that risk,’ Dr Mahady said.
‘Now we have a much clearer picture of the additional risk of bleeding with aspirin and that taking aspirin when you have additional risk factors including hypertension, a history of smoking, kidney disease or with anti-inflammatory medication, could be quite dangerous.
‘Prescribing doctors may now use these data to assess the bleeding risk of aspirin use among their older patients, and may alternatively target the modifiable risk factors to reduce harm.’
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