Recent study demonstrates prevention of serious vascular events with aspirin use in diabetes; however, participants also experienced major bleeding events.
It is well known that aspirin use is beneficial for patients who have cardiovascular disease, but it is less transparent for those who have not yet had a cardiovascular event. Patients with diabetes have a two-to-three-times greater risk of having a vascular event, compared to those without the disease. There have been previous studies to compare risk vs. benefit for patients taking a daily low-dose aspirin, but only a few have made comparisons in patients with diabetes. Researchers performed the ASCEND (A Study of Cardiovascular Events in Diabetes) randomized trial to examine the efficacy and safety of 100 mg aspirin, as compared with placebo, in patients with diabetes and without any cardiovascular events prior to trial entry.
A total of 15,480 participants were found using regional diabetes registers or general practices from around the United Kingdom and were sent questionnaires. Those who completed the questionnaire and were eligible were entered in a prerandomization run-in phase, during which they received placebos (n-3 fatty acids) for 8-10 weeks. If patients were still eligible, they were assigned to received 100 mg of aspirin once daily, or continue the placebo. Questionnaires were sent out every 6 months until the end of the trial, seeking information regarding serious adverse events, adherence, use of other antiplatelet or anticoagulation therapy, non serious adverse events resulting in discontinuation, and bleeding episodes for which the patient was seen by a doctor. After an average follow up of 7.4 years, blood and urine samples, along with blood pressure, height, and weight were taken and compared to baseline.
Serious vascular events occurred in a significantly lower percentage of patients in the aspirin group compared to the placebo group (658 participants [8.5%] vs. 743 [9.6%]; rate ratio, 0.88; 95% confidence interval [CI], 0.79 to 0.97; P=0.01). On the other hand, major bleeding events occurred in 314 participants (4.1%) taking aspirin, as compared with 245 (3.2%) taking the placebo (rate ratio, 1.29; 95% CI, 1.09 to 1.52; P=0.003), with most of the excess being gastrointestinal bleeding and other extracranial bleeding. There was no significant difference between the aspirin group and the placebo group in the incidence of gastrointestinal tract cancer (157 participants [2.0%] and 158 [2.0%], respectively) or all cancers (897 [11.6%] and 887 [11.5%]). A long-term follow-up is planned for these outcomes.
In conclusion, aspirin use prevented serious vascular events in participants who had diabetes without cardiovascular disease before the trial, but the aspirin use also caused major bleed events. The absolute benefits of aspirin use in patients with diabetes were greatly outweighed by the bleeding hazards.
- Researchers performed the ASCEND randomized trial to examine the efficacy and safety of 100 mg aspirin, as compared with placebo, in patients with diabetes and without any cardiovascular events prior to trial entry.
- The absolute benefits of aspirin use in patients with diabetes were greatly outweighed by the bleeding hazards.
The New England Journal of Medicine
“Effects of Aspirin for Primary Prevention in Persons With Diabetes Mellitus” N. Engl. J. Med. 2018 Aug; The ASCEND Study Collaborative Group
Melissa Bailey, Pharm.D. Candidate, USF College of Pharmacy
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