HMG COA REDUCTASE INHIBITORS IN THE ELDERLY

这是一份为期两年的提案，响应RFA NIH 89-HL-06-H： “HMG CoA还原酶抑制剂在老年人中的应用：初步研究。”一个 将启动多中心试点，以确定 大型临床试验。第一年将致力于协议设计。 第二年将讨论执行议定书的可行性。 解决三个主要问题： 1)一项与当前临床实践标准一致的方案 (也应考虑科学界的标准) 旨在解决主要研究问题并监测 参与者？所提出的协议有效地回答了这个问题，并且 建议使用HMG辅酶A还原酶进行双盲安慰剂对照试验 其主要作用是降低血浆低密度脂蛋白-C。虽然 没有确凿的证据表明降低胆固醇对健康有益。 这一年龄组、纳入/排除标准和监测考虑 现行的NCEP指南，主要风险因素的影响和使用 一种HMG辅酶A还原酶抑制剂。 2)怎样才能将这种试验的成本降到最低？该协议的地址为 这一问题最大限度地利用了具有适当技能的人员 指定的任务；高效的协议设计，以最大限度地减少 参赛者将不会被随机和明智地使用实验室 测试、毒性研究和其他数据收集。 3)能否招募足够数量的男性和女性参加 这样的审判？目前的经验表明，大规模的招聘 老年参与者的数量是可能的。这项提案的重点是 确定四种招聘方法的成本效益：媒体、 宣传册邮寄、推荐和实地筛选。两百人参加 将在这项试点研究期间招聘(最少要求150人)， 明尼苏达大学和伯曼中心的共同努力。 为了完成这些任务，具有丰富经验的个人 给药，临床试验，招募，血脂，药理学， 老年人的营养、依从性、数据收集和管理 临床试验的参与者将执行所需的任务。

This is a two year proposal which is in response to RFA NIH 89-HL-06-H: "HMG CoA Reductase Inhibitors in the Elderly: Pilot Study." A multi-center pilot will be initiated to determine the feasibility of a large clinical trial. The first year will be devoted to protocol design. The second year will address the feasibility of implementing the protocol addressing three major issues: 1) Can a protocol consistent with current standards of clinical practice (standards of the scientific community should also be considered) be designed to address the major research questions and monitor the safety of participants? The proposed protocol answers this question effectively and suggests a double-blind placebo-controlled trial using an HMG CoA reductase inhibitor whose major effect will be a lowering of plasma LDL-C. Although there is no conclusive evidence of benefit from cholesterol lowering in this age group, the inclusion/exclusion criteria, and monitoring consider the current NCEP Guidelines, the impact of major risk factors and the use of an HMG CoA reductase inhibitor. 2) How can the costs of such a trial be minimized? This protocol addresses this issue by maximum utilization of personnel with skills appropriate for given tasks; efficient protocol design to minimize the efforts on participants who will not be randomized and judicious use of laboratory tests, toxicity studies and other data collection. 3) Can an adequate number of men and women be recruited to participate in such a trial? Current experience suggests that recruitment of large numbers of elderly participants is possible. This proposal focuses on establishing the cost-effectiveness of four recruitment methods: media, brochure mailings, referrals and field screening. Two hundred participants will be recruited (150 minimum requested) during this pilot study, with the joint efforts of the University of Minnesota and Berman Center. To accomplish these tasks, individuals with extensive experience in administration, clinical trials, recruitment, lipidology, pharmacology, nutrition, adherence, data collection, and management of elderly participants in clinical trials will perform the required tasks.