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Aspirin does not appear to increase risk for fatal GI bleeding
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While gastrointestinal bleeding is the most common adverse event caused by preventive low-dose aspirin regimens, there is no evidence that aspirin increases the frequency of fatal gastrointestinal bleeding, according to a systematic review and meta-analysis.
“Although many people use aspirin daily to reduce the risk of health problems such as cancer and heart disease, the wider use of the drug is severely limited because of the side effect of bleeding from the stomach,” Peter C. Elwood, MD, from Cardiff University School of Medicine in the U.K., said in a press release. “With our study showing that there is no increased risk of death from stomach bleeding in people who take regular aspirin, we hope there will be better confidence in the drug and wider use of it by older people, leading to important reductions in deaths and disablement from heart disease and cancer across the community.”
As most GI bleeds are acute and patients often completely recover from them, Elwood and colleagues proposed that a more appropriate way to evaluate the risk–benefit profile of daily aspirin regimens would be to assess the rate of fatal GI bleeding events rather than the overall incidence. They therefore identified 11 randomized controlled trials of aspirin that reported both incident and fatal GI bleeding events, and performed a meta-analysis to determine the risk for fatal GI bleeding associated with aspirin.
“We analyzed three outcomes: the risk of GI bleed attributable to aspirin, the risk of fatal GI bleed among those who bled, and the risk of a fatal bleed in subjects who had been randomized to receive aspirin,” Elwood and colleagues wrote.
They found that aspirin increased the frequency of GI bleeds by about 60% (RR = 1.55; 95% CI, 1.33-1.83), but GI bleeds that resulted in death appeared to be decreased among patients taking aspirin (RR = 0.45; 95% CI, 0.25-0.8).
They also found no evidence of a significant increase in fatal GI bleeds related to aspirin; fatal GI bleeding occurred in 3.7 ± 1.6 per 10,000 patients who received aspirin compared with 4.7 ± 1.8 per 10,000 controls who did not receive aspirin (RR = 0.77; 95% CI, 0.41-1.43).
“The basic conclusion from our study is that although aspirin increases risk of GI bleeding, the overall risk of fatal bleeding is not significantly elevated, and the fatality rate, should GI bleeding occur, is significantly reduced,” the researchers concluded. The most likely explanation for “these seemingly contradictory findings ... is that aspirin, through its anti-thrombotic effect may unmask gastrointestinal pathology early in its natural history, when the anatomical extent of the lesion is more limited, and the risk of massive uncontrolled bleeding lower and medical intervention is associated with the highest likelihood of success.”
These findings also highlight that the most important risk associated with aspirin regimens is cerebral hemorrhage, with about one death and one disabling stroke occurring in every 1,000 people taking aspirin for 10 years, the researchers noted.
“All these conclusions are relevant to the risk–benefit balance of aspirin prophylaxis and should be communicated to subjects at risk of vascular disease and/or cancer,” they wrote. – by Adam Leitenberger
Disclosures: Elwood reports he was an advisor to Bayer HealthCare and a member of the board of the International Aspirin Foundation. Please see the full study for a list of all other researchers’ relevant financial disclosures.
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