Washington: In a new study, daily use of low-dose aspirin was found to be associated with an increased risk of major gastrointestinal or cerebral bleeding among nearly 200,000 individuals.
Researchers also found that patients with diabetes had a high rate of major bleeding, irrespective of aspirin use.
“Therapy with low-dose aspirin is used for the treatment of cardiovascular disease. It is recommended as a secondary prevention measure for individuals with moderate to high risk of cardiovascular events (i.e., for patients with multiple risk factors such as hypertension, dyslipidemia, obesity, diabetes, and family history of ischemic heart disease),” the researchers said.
“Any benefit of low-dose aspirin might be offset by the risk of major bleeding. It is known that aspirin is associated with gastrointestinal and intracranial hemorrhagic complications. However, randomized controlled trials have shown that these risks are relatively small,” they stated.
They added that randomized controlled trials evaluate selected patient groups and do not necessarily generalize to an entire population.
Giorgia De Berardis, M.Sc., of Consorzio Mario Negri Sud, Santa Maria Imbaro, Italy, and colleagues conducted a study to determine the incidence of major gastrointestinal and intracranial bleeding episodes in individuals with and without diabetes taking aspirin.
For the study, the researchers used administrative data from 4.1 million citizens in 12 local health authorities in Puglia, Italy. Individuals with new prescriptions for low-dose aspirin (300 mg or less) were identified during the index period from January 2003 to December 2008, and were matched with individuals who did not take aspirin during this period.
For the study, the researchers included 186,425 individuals being treated with low-dose aspirin and 186,425 matched controls without aspirin use. During 6 years, 6,907 first episodes of major bleeding requiring hospitalization were registered, of which there were 4,487 episodes of gastrointestinal bleeding and 2,464 episodes of intracranial hemorrhage.
Analysis indicated that the use of aspirin was associated with a 55 percent increased relative risk of gastrointestinal bleeding and 54 percent increased relative risk of intracranial bleeding.
The researchers noted that in comparison with other estimates of rates of major bleeding, their findings indicate a 5-times higher incidence of major bleeding leading to hospitalization among both aspirin users and those without aspirin use.
The researchers also found that the use of aspirin was associated with a greater risk of major bleeding in most of the subgroups evaluated, but not in individuals with diabetes.
Diabetes was independently associated with a 36 percent increased relative risk of major bleeding episodes, irrespective of aspirin use.
Among individuals not taking aspirin, those with diabetes had an increased relative risks of 59 percent for gastrointestinal bleeding and 64 percent for intracranial bleeding.
“Our study shows, for the first time, to our knowledge, that aspirin therapy only marginally increases the risk of bleeding in individuals with diabetes. These results can represent indirect evidence that the efficacy of aspirin in suppressing platelet function is reduced in this population,” the authors write.
The finding appeared in latest issue of JAMA.