ASPirin in Reducing Events in the Elderly

描述(申请人提供)：本申请寻求资助阿司匹林在70岁及以上健康老年人一级预防中的随机、双盲、安慰剂对照试验。其目的是确定小剂量阿司匹林是否会延长老龄化人口的无残疾生活时间。这项研究将检验这种药物的潜在好处(特别是在预防心脏病、中风和血管性痴呆方面)是否超过了这个年龄段严重出血的风险。 19,000名参与者将从美国和澳大利亚的社区环境中招募，并被随机分配到每天100毫克的肠溶阿司匹林或安慰剂。平均随访5年。试验方法基于在两个国家成功进行的大规模临床结果研究，例如ALLHAT，第二次澳大利亚全国血压研究。 ASPREE的这项研究符合国家老龄研究所四大目标中的第一个--“改善老年人的健康和生活质量”。NIA的老龄化研究行动计划指出，自20世纪初以来，美国出生时预期寿命从不到50岁增加到76岁以上。从1960年到2000年，65岁及以上的人口大约翻了一番。进一步预测，到2030年，65岁及以上的人口数量将再翻一番，达到7030万人(占人口的20%)。老年人口的急剧增长还预测，85岁及以上的美国人数量将达到1940万(2050年占总人口的4.8%)。随着预期寿命的增加，现在更有必要保持这些额外的寿命不受疾病和残疾的影响。 目前，阿司匹林作为一级预防的使用主要是基于对不良反应发生率较低的中年人的研究。然而，这种制剂在老年人中的风险收益比率仍然是一个持续存在争议的领域。这一点体现在将阿司匹林疗法纳入一些广受尊重的临床指南中，尽管FDA心肾药物小组未能批准在这种情况下使用阿司匹林。ASPREE阿司匹林研究的结果将有可能改变大多数美国老年人口的临床实践，在这些人中，65岁以上的人中约有60%没有心脏病、中风以及精神或身体残疾。有数据表明，阿司匹林可能会延缓认知能力下降和某些形式的癌症的发生，这增强了阿司匹林的相关性。然而，最近新推出的其他主要药物治疗的经验，如HRT、COX-2抑制剂和抗氧化维生素，强调了在这些治疗进入常规实践之前正式确立安全性和有效性的必要性。

DESCRIPTION (provided by applicant): This Application seeks funding for a randomized double-blind placebo-controlled trial of aspirin in primary prevention in healthy elderly people aged 70 years and over. Its purpose is to determine whether low dose aspirin will extend the duration of disability-free life in an aging population. The study will examine whether the potential benefits of this drug (particularly the prevention of heart disease, stroke and vascular dementia) outweigh the risks of severe bleeding in this age group. 19,000 participants will be recruited from community settings in the United States and Australia and randomized to daily 100 mg of enteric-coated aspirin or placebo. Follow-up is for an average of 5 years. The trial methods are based around the successful conduct of large-scale clinical outcome studies in both countries, e.g., ALLHAT, 2nd Australian National Blood Pressure study. The ASPREE study accords with the first of the four major goals of the National Institute of Aging - "to improve the health and quality of life of older people". The Action Plan for Aging Research of the NIA points out that since the beginning of the 20th century, life expectancy at birth in the U.S. has increased from less than 50 years to more than 76 years. From 1960 to 2000 there was an approximate doubling of people aged 65 and over. It is further predicted that by the year 2030, the number of individuals aged 65 and over will double again to reach 70.3 million (constituting 20% of the population). Dramatic growth in the elderly population is also predicted in the number of Americans aged 85 and over to reach 19.4 million (4.8% of the population in 2050). As life expectancy increases, there is now a greater need to keep these additional years free of disease and disability. At present, the use of aspirin for primary prevention is based largely on studies in middle aged adults where the incidence of adverse affects is low. However, the risk benefit ratio of this agent in older persons is an area of continuing controversy. This is reflected by incorporating aspirin therapy into some widely respected clinical guidelines, despite the failure of the FDA cardio-renal Drugs Panel to endorse its use in this setting. The result of the ASPREE aspirin study will have the potential to alter clinical practice for the majority of the older U.S. population where approximately 60% of those over 65 are free of heart disease, stroke and mental or physical disability. Its relevance is enhanced by the data suggesting that aspirin may delay the onset of cognitive decline and some forms of cancer. However, recent experience with other major drug therapies newly introduced, e.g., HRT, COX-2 inhibitors and anti-oxidant vitamins, has emphasized the need to formally establish safety and efficacy before such therapies enter routine practice.