First Department of Internal Medicine, Nara Medical University.
Circ J. 2013;77(12):3023-8. doi: 10.1253/circj.cj-13-0307. Epub 2013 Sep 13.
Benefit of low-dose aspirin for primary prevention of cardiovascular events in diabetes remains controversial. The American Diabetes Association (ADA), the American Heart Association (AHA), and the American College of Cardiology Foundation (ACCF) recommend aspirin for high-risk diabetic patients: older patients with additional cardiovascular risk factors. We evaluated aspirin's benefit in Japanese diabetic patients stratified by cardiovascular risk.
In the JPAD trial, we enrolled 2,539 Japanese patients with type 2 diabetes and no history of cardiovascular disease. We randomly assigned them to aspirin (81-100 mg daily) or no aspirin groups. The median follow-up period was 4.4 years. We stratified the patients into high-risk or low-risk groups, according to the US recommendation: age (older; younger) and coexisting cardiovascular risk factors. The risk factors included smoking, hypertension, dyslipidemia, family history of coronary artery disease, and proteinuria. Most of the patients were classified into the high-risk group, consisting of older patients with risk factors (n=1,804). The incidence of cardiovascular events was higher in this group, but aspirin did not reduce cardiovascular events (hazard ratio [HR], 0.83; 95% confidence interval [CI]: 0.58-1.17). In the low-risk group, consisting of older patients without risk factors and younger patients (n=728), aspirin did not reduce cardiovascular events (HR, 0.55; 95% CI: 0.23-1.21). These results were unchanged after adjusting for potential confounding factors.
Low-dose aspirin is not beneficial in Japanese diabetic patients at high risk.
低剂量阿司匹林用于糖尿病患者一级预防心血管事件的获益仍存在争议。美国糖尿病协会（ADA）、美国心脏协会（AHA）和美国心脏病学会基金会（ACCF）建议高危糖尿病患者（年龄较大且有其他心血管危险因素的患者）使用阿司匹林。我们评估了阿司匹林在按心血管风险分层的日本糖尿病患者中的获益。
在 JPAD 试验中，我们纳入了 2539 例无心血管疾病史的日本 2 型糖尿病患者。我们将他们随机分配至阿司匹林（81-100mg/天）或无阿司匹林组。中位随访时间为 4.4 年。根据美国的建议，我们将患者分为高危或低危组：年龄（较大；较小）和并存的心血管危险因素。危险因素包括吸烟、高血压、血脂异常、冠心病家族史和蛋白尿。大多数患者被归入高危组，包括有危险因素的老年患者（n=1804）。该组心血管事件的发生率较高，但阿司匹林并未降低心血管事件的发生率（风险比[HR]，0.83；95%置信区间[CI]：0.58-1.17）。在低危组中，包括无危险因素的老年患者和年轻患者（n=728），阿司匹林也未降低心血管事件的发生率（HR，0.55；95%CI：0.23-1.21）。在调整了潜在混杂因素后，这些结果仍保持不变。
低剂量阿司匹林对日本高危糖尿病患者无益。
