Background

Diabetes mellitus is associated with an increased risk of cardiovascular events. Aspirin use reduces the risk of occlusive vascular events but increases the risk of bleeding; the balance of benefits and hazards for the prevention of first cardiovascular events in patients with diabetes is unclear.

Methods

We randomly assigned adults who had diabetes but no evident cardiovascular disease to receive aspirin at a dose of 100 mg daily or matching placebo. The primary efficacy outcome was the first serious vascular event (i.e., myocardial infarction, stroke or transient ischemic attack, or death from any vascular cause, excluding any confirmed intracranial hemorrhage). The primary safety outcome was the first major bleeding event (i.e., intracranial hemorrhage, sight-threatening bleeding event in the eye, gastrointestinal bleeding, or other serious bleeding). Secondary outcomes included gastrointestinal tract cancer.

Results

A total of 15,480 participants underwent randomization. During a mean follow-up of 7.4 years, serious vascular events occurred in a significantly lower percentage of participants in the aspirin group than in 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). In contrast, major bleeding events occurred in 314 participants (4.1%) in the aspirin group, as compared with 245 (3.2%) in the placebo group (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%]); long-term follow-up for these outcomes is planned.

Conclusions

Aspirin use prevented serious vascular events in persons who had diabetes and no evident cardiovascular disease at trial entry, but it also caused major bleeding events. The absolute benefits were largely counterbalanced by the bleeding hazard. (Funded by the British Heart Foundation and others; ASCEND Current Controlled Trials number, ISRCTN60635500; ClinicalTrials.gov number, NCT00135226.)

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Aspirin for Primary Prevention in Diabetes Mellitus
 01:36

中文翻译：

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阿司匹林在糖尿病患者一级预防中的作用

背景

糖尿病与心血管事件的风险增加有关。阿司匹林的使用降低了阻塞性血管事件的风险，但增加了出血的风险；预防糖尿病患者首次发生心血管事件的利弊之间的平衡尚不清楚。

方法

我们随机分配患有糖尿病但无明显心血管疾病的成年人接受每日100 mg剂量的阿司匹林或匹配的安慰剂。主要疗效结果是首次发生严重的血管事件（即，心肌梗塞，中风或短暂性脑缺血发作，或由于任何血管原因导致的死亡，但不包括任何确诊的颅内出血）。主要安全结果是第一次严重出血事件（即颅内出血，眼部视力出血事件，胃肠道出血或其他严重出血）。次要结局包括胃肠道癌。

结果

共有15480名参与者进行了随机分组。在平均7.4年的随访期间，阿司匹林组参与者的严重血管事件发生率显着低于安慰剂组（658名参与者[8.5％]比743名[9.6％]；比率为0.88； 95％置信区间[CI]为0.79至0.97； P = 0.01）。相比之下，阿司匹林组有314名参与者（4.1％）发生了大出血事件，而安慰剂组有245名（3.2％）（发生率，1.29； 95％CI，1.09至1.52； P = 0.003），其中大部分是胃肠道出血和其他颅外出血。阿司匹林组和安慰剂组在胃肠道癌（分别为157人[2.0％]和158人[2.0％]）或所有癌症（897人[11.6％]和887人[11.5％]的发生率上无显着差异。 ]）;

结论

服用阿司匹林可以预防糖尿病患者的严重血管事件，并且在试验开始时未发现明显的心血管疾病，但也会引起严重的出血事件。绝对的好处在很大程度上被出血的危害所抵消。（由英国心脏基金会和其他机构资助； ASCEND当前对照试验编号，ISRCTN60635500； ClinicalTrials.gov编号，NCT00135226。）

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阿司匹林在糖尿病的一级预防中的作用
 01:36