ASPirin in Reducing Events in the Elderly

阿司匹林在减少老年人事件中的作用

• 批准号: 8131805
• 负责人: Richard Hugo Grimm
• 金额: $ 854.26万
• 依托单位: HENNEPIN HEALTHCARE RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-15 至 2018-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8131805
• 关键词: Accounting; Adult; Adverse effects; Affect; Aging; American; Antioxidants; Area; Aspirin; Australia; Benefits and Risks; Birth; Blood Pressure; Cardiovascular system; Categories; Cessation of life; Clinical; Communities; Coronary heart disease; Country; DSM-IV; Data; Dementia; Developed Countries; Disease; Dose; Double-Blind Method; Elderly; Enteral; Evaluation; Event; Failure; Funding; Goals; Growth; Guidelines; Health; Heart Diseases; Heart failure; Hemorrhage; Hospitalization; Impaired cognition; Incidence; Independent Living; Individual; Institutes; Kidney; Life; Life Expectancy; Malignant Neoplasms; Measurement; Measures; Methods; Myocardial Infarction; Older Population; Outcome Study; PTGS2 gene; Participant; Pharmaceutical Preparations; Pharmacotherapy; Placebo Control; Placebos; Population; Population Study; Prevention; Primary Prevention; Psyche structure; Quality of life; Randomized; Recruitment Activity; Research; Risk; Safety; Skin Carcinoma; Stroke; United States; Vascular Dementia; Vitamins; adjudication; age group; aged; aging population; base; clinical practice; community setting; disability; double-blind placebo controlled trial; experience; follow-up; heart disease prevention; improved; inhibitor/antagonist; loss of function; middle age; mild cognitive impairment; mortality; novel; primary outcome; risk benefit ratio; routine practice

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.

描述（由申请人提供）：本申请为在70岁及以上的健康老年人中，为阿司匹林进行一项随机的双盲安慰剂对照试验提供资金。其目的是确定低剂量阿司匹林是否会延长老年人口中无残疾生活的持续时间。该研究将检查该药物的潜在益处（尤其是心脏病，中风和血管性痴呆）是否大于该年龄段严重出血的风险。 将从美国和澳大利亚的社区环境中招募19,000名参与者，并随机分配到每天100毫克肠涂的阿司匹林或安慰剂。随访平均为5年。该试验方法基于在两个国家 /地区的大规模临床结果研究（例如Allhat，第二澳大利亚国家血压研究）的成功进行。 ASPREE研究符合美国国家老化研究所的四个主要目标中的第一个 - “改善老年人的健康和生活质量”。 NIA衰老研究的行动计划指出，自20世纪初以来，美国出生时的预期寿命已从不到50年增加到76年以上。从1960年到2000年，65岁及以上的人大约翻了一番。进一步预测，到2030年，65岁及65岁以上的个人人数将再次翻一番，达到7030万（占人口的20％）。还可以预测，在85岁及85岁及以上的美国人数量达到1,940万（2050年人口的4.8％）中，老年人口的急剧增长也被预测。随着预期寿命的提高，现在有更大的需求使这些额外的几年没有疾病和残疾。 目前，阿司匹林用于原发性预防，主要是基于中年成年人的研究，而中年成年人的发生率很低。但是，该代理商在老年人中的风险收益比是一个持续争议的领域。尽管FDA心脏 - 肾脏药物面板未能在这种情况下使用其使用，但通过将阿司匹林治疗纳入一些广受尊重的临床指南中反映了这一点。 ASPREE阿司匹林研究的结果将有可能改变大多数美国老年人群的临床实践，而大多数65岁以上的人中约有60％没有心脏病，中风，心理或身体残疾。数据表明阿司匹林可能会延迟认知能力下降和某些形式的癌症的发作，从而提高了其相关性。但是，最近引入的其他主要药物疗法的最新经验，例如HRT，COX-2抑制剂和抗氧化维生素，强调需要在这种治疗进行常规实践之前正式建立安全性和有效性。