Clinical Trial Service Unit, Richard Doll Building, Old Road Campus, Roosevelt Drive, Headington, Oxford; Medical Research Council Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, England.
Clinical Trial Service Unit, Richard Doll Building, Old Road Campus, Roosevelt Drive, Headington, Oxford; Medical Research Council Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, England.
Am Heart J. 2018 Apr;198:135-144. doi: 10.1016/j.ahj.2017.12.006. Epub 2017 Dec 24.
The use of aspirin for the secondary prevention of cardiovascular disease (CVD) is firmly established, and the proportional reductions in heart attacks and strokes appear to be similar in people with and without diabetes. Uncertainty remains about the role of antiplatelet treatments for primary prevention of CVD, and guidelines vary in their recommendations. It has also been hypothesized that long-term aspirin can prevent gastro-intestinal and other cancers. Observational studies suggest associations between higher intakes of omega-3 fatty acids (FA) and lower rates of CVD, but there is no large-scale randomized evidence to support using prophylactic omega-3 FA supplementation in primary prevention. ASCEND is a randomized trial assessing whether 100 mg daily aspirin safely prevents CVD and cancer in patients with diabetes without known arterial disease. It is also assessing whether supplementation with 1 g omega-3 FA daily prevents CVD. This paper describes the methods and baseline characteristics of the randomized participants.
Between 2005 and 2011, using mail-based methods, 15,480 people with diabetes were randomized to aspirin versus placebo and, in a factorial design, to omega-3 FA supplementation versus placebo. Blood and urine samples were collected to allow baseline stratification by biochemical prognostic variables (e.g. HbA1c, blood lipids). Follow-up is for a median of at least 7 years.
Demonstrating that prophylactic aspirin safely reduces the risk of CVD or cancer in the primary prevention setting, or that omega-3 FA supplementation prevents CVD, would be relevant to hundreds of millions of people worldwide who are currently not receiving such therapies. The results of ASCEND will be reported in 2018.
阿司匹林用于二级预防心血管疾病（CVD）已得到充分证实，且心脏病发作和中风的比例减少似乎在有或没有糖尿病的人群中相似。对于抗血小板治疗在 CVD 一级预防中的作用仍存在不确定性，指南中的推荐意见也存在差异。人们还假设长期服用阿司匹林可以预防胃肠道和其他癌症。观察性研究表明，ω-3 脂肪酸（FA）摄入量较高与 CVD 发生率较低之间存在关联，但没有大规模随机证据支持在一级预防中使用预防性ω-3 FA 补充剂。ASCEND 是一项评估每天服用 100 毫克阿司匹林是否能安全预防无已知动脉疾病的糖尿病患者发生 CVD 和癌症的随机试验。它还评估了每天补充 1 克 ω-3 FA 是否能预防 CVD。本文介绍了随机参与者的方法和基线特征。
2005 年至 2011 年间，通过邮寄方式，将 15480 名患有糖尿病的患者随机分为阿司匹林组与安慰剂组，以及在析因设计中，将 ω-3 FA 补充剂组与安慰剂组。采集血样和尿样，以允许根据生化预后变量（如 HbA1c、血脂）进行基线分层。中位随访时间至少为 7 年。
如果证明预防性阿司匹林能安全降低一级预防人群中 CVD 或癌症的风险，或者 ω-3 FA 补充剂能预防 CVD，这将与目前未接受此类治疗的全球数亿人有关。ASCEND 的结果将于 2018 年公布。
