小剂量阿司匹林的使用并不能减少2型糖尿病患者的心血管事件

[有伤]

转自丁香园
Context: Previous trials have investigated the effects of low-dose aspirin on primary prevention of cardiovascular events, but not in patients with type2 diabetes.
Objective: To examine the efficacy of low-dose aspirin for the primary prevention of atherosclerotic events in patients with type2 diabetes.
Design, Setting, and Participants: Multicenter, prospective, randomized, openlabel, blinded, end-point trial conducted from December 2002 through April 2008 at 163 institutions throughout Japan, which enrolled 2539 patients with type2 diabetes without a history of atherosclerotic disease and had a median follow-up of 4.37 years.
Interventions:Patients were assigned to the low-dose aspirin group (81 or 100 mg per day) or the nonaspirin group.
Main Outcome Measures: Primary end points were atherosclerotic events, including fatal or nonfatal ischemic heart disease, fatal or nonfatal stroke, and peripheral arterial disease. Secondary end points included each primary end point and combinations of primary end points as well as death from any cause.
Results: A total of 154 atherosclerotic events occurred: 68 in the aspirin group (13.6 per 1000 person-years) and 86 in the nonaspirin group (17.0 per 1000 person-years)(hazard ratio

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, 0.80; 95% confidence interval [CI], 0.58-1.10; log-rank test, P=.16).The combined end point of fatal coronary events and fatal cerebrovascular events occurred in 1 patient (stroke) in the aspirin group and 10 patients (5 fatal myocardial infarctions and 5 fatal strokes) in the nonaspirin group (HR, 0.10; 95% CI, 0.01-0.79;P=.0037). A total of 34 patients in the aspirin group and 38 patients in the nonaspirin group died from any cause (HR, 0.90; 95% CI, 0.57-1.14; log-rank test, P=.67). The composite of hemorrhagic stroke and significant gastrointestinal bleeding was not significantly different between the aspirin and nonaspirin groups.
Conclusion: In this study of patients with type 2 diabetes, low-dose aspirin as primary prevention did not reduce the risk of cardiovascular events.
背景：此前的很多试验已经研究过小剂量阿司匹林对于心血管事件的一级预防作用，但是对患有2型糖尿病的患者，并无相关研究。
目的：明确小剂量阿司匹林对2型糖尿病患者动脉粥样硬化事件的一级预防作用。
设计，场所，对象：多中心、前瞻性、随机开放的终点性试验于2002年12月至2008年4月之间在日本163家机构进行，包括2539名无动脉粥样硬化疾病史的2型糖尿病患者，平均随访时间4.37年。
干预措施：患者分为阿司匹林组（每日81或100mg阿司匹林）和非阿司匹林组。
主要结果评价：一级终点是动脉粥样硬化事件，包括致命或非致命性缺血性心脏疾病，致命性或非致命性卒中以及周围动脉疾病。次级终点包括每种一级终点事件，多种一级终点事件的联合还有全因死亡。
结果：共有154名患者发生动脉粥样硬化事件，阿司匹林组68名（13.6人/1000人/年），非阿司匹林组86名（17.0人/1000人/年）（危险比0.80；95%置信区间0.58~1.10；对数秩和检验P=0.16）。致命性冠脉事件和致命性脑血管事件的联合终点在阿司匹林组发生1例（卒中），非阿司匹林组发生10例（5例致命性心肌梗死和5例致命性卒中）（危险比0.10；95%置信区间0.01~0.79；对数秩和检验P=0.0037）。阿司匹林组34人和非阿司匹林组38人为全因死亡（危险比0.90；95%置信区间0.57~1.14；对数秩和检验P=0.67）。两组出血性卒中和明显的胃肠道出血并无统计学差异。
结论：在2型糖尿病患者的研究中，小剂量阿司匹林作为一级预防并不能减少心血管事件风险。