"Aspirin for Primary Prevention in Diabetes Mellitus"
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The New England Journal of Medicine. Date of publication not provided. PubMed•Full text•PDF
Contents 1 Clinical Question 2 Bottom Line 3 Major Points 4 Guidelines 5 Design 6 Population 6.1 Inclusion Criteria 6.2 Exclusion Criteria 6.3 Baseline Characteristics 7 Interventions 8 Outcomes 8.1 Primary Outcomes 8.2 Secondary Outcome 9 Criticisms 10 Funding 11 Further Reading
Does aspirin reduce the risk of serious vascular events in adults with diabetes who do not have evident cardiovascular disease?
Aspirin use in persons with diabetes without evident cardiovascular disease reduced the risk of serious vascular events but increased the risk of major bleeding events. The benefits were largely counterbalanced by the bleeding hazard.
The ASCEND trial assessed the efficacy and safety of aspirin in diabetes patients without cardiovascular disease. The study found a 12% reduction in serious vascular events with aspirin, but also a 29% increased risk for major bleeding events. The absolute benefits and risks were similar in magnitude, suggesting precise balance in this population.
Guidelines reflecting the results of this trial are not specified in the provided text.
- Multicenter, double-blind, parallel-group, randomized, placebo-controlled trial - N=15,480 adults with diabetes and no evident cardiovascular disease
Inclusion Criteria: - Diagnosis of diabetes mellitus (type not specified) - No known cardiovascular disease - Uncertainty surrounding benefit of antiplatelet therapy
Exclusion Criteria: - Indication or contraindication for aspirin use - Other significant conditions impacting adherence to 5-year regimen
Baseline Characteristics: - Well-balanced between both groups - Aspirin use prior to screening present in 35.6% of participants
- Randomized to receive either 100 mg of aspirin once daily or matching placebo
Primary Outcomes: - Serious vascular events (myocardial infarction, stroke or transient ischemic attack, death from vascular causes excluding intracranial hemorrhage): lower in aspirin group (8.5% vs 9.6% placebo) - Major bleeding events (intracranial hemorrhage, eye bleeding, gastrointestinal bleeding, and other serious bleeding): higher in aspirin group (4.1% vs 3.2% placebo)
Secondary Outcome: - Gastrointestinal tract cancer incidence: no significant difference between the aspirin and placebo groups - Other cancers (fatal or nonfatal): no significant difference between groups
The provided text does not articulate specific criticisms of the trial.
Funded by the British Heart Foundation, Bayer (Germany and the United States), Solvay, Abbott, and Mylan. Trial drugs and matching placebo were provided by Bayer.
Not specified in the article text.