Abstract
Benefit of low-dose aspirin for primary prevention of cardiovascular events remains controversial in diabetic patients. Recently, the ADA, AHA and ACCF jointly recommended that low-dose aspirin use is reasonable for high-risk diabetic patients: older patients with additional cardiovascular risk factors. Thus, we evaluated aspirin's benefit in diabetic patients stratified by cardiovascular risk factors in the JPAD trial. This study is a subanalysis of the JPAD trial: a randomized, controlled trial to assess whether low-dose aspirin reduced cardiovascular events in patients with type 2 diabetes and no history of cardiovascular disease. We randomly assigned 2,539 patients to the aspirin group (81 or 100 mg daily) or the no aspirin group, and followed for 4.4 years. We classified all participants into four subgroups according to the following risk stratification: age (men, >50 or ≤50 years; women, >60 or ≤60 years) and one or more additional risk factors (smoking, hypertension, dyslipidemia, family history of coronary artery disease, and proteinuria). Most of the participants were older patients with risk factors (group A: n = 1,804); however, aspirin did not reduce cardiovascular events in the group A (hazard ratio [HR]: 0.83, 95% confidence interval [CI]: 0.58 to 1.17). On the other hand, in older patients without risk factors (group B: n = 268), aspirin significantly reduced cardiovascular events (HR: 0.24, 95% CI: 0.04 to 0.89). Either in younger patients with risk factors (group C: n = 402) or without risk factors (group D: n = 58), we could not detect aspirin's benefit (group C, HR: 0.93, 95% CI: 0.27 to 2.9; group D, HR: 1.26, 95% CI: 0.05 to 32). In the present study, low-dose aspirin was beneficial for primary prevention not in older diabetic patients with additional risk factors but in those without additional risk factors. Further investigations should be needed to confirm whether low-dose aspirin is beneficial for primary prevention in diabetic patients at high risk.
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