HMG COA REDUCTASE INHIBITORS IN THE ELDERLY

最近关于血脂升高和高血压的危险因素状态的争论 脂蛋白与老年冠心病发病率和死亡率的关系 成年人强调需要一个设计得当的对照临床 在这一人群中测试降低胆固醇的效果。HMG 辅酶A还原酶抑制剂是有效的降胆固醇药物 不良反应最小，可作为感兴趣的药物类别。 这项提案将在北卡罗来纳大学的 协作研究协调中心(CSCC) 一项测试HMG CoA更大规模试验可行性的先导性研究 老年人中的还原酶抑制剂。CSCC建议：(A) 与研究人员合作设计具有成本效益的研究 议定书；(B)带头建立适当的数据收集 文书；(C)提供行政支助(例如会议安排 和会议记录、中央通信、手稿制作)；(D)开发和 实施数据管理系统；(E)培训诊所工作人员，编写 详细的操作手册，并提供临床支持(例如协议 (F)在研究期间监测和维持数据质量 诊所和实验室；(G)为调查人员编制统计报告 和监测委员会；以及(H)协调出版工作。特定的 实现这些目标的计划，以及CSCC在这方面的经验 对其他合作心血管研究的活动进行了详细介绍。 建议试点研究以纸质数据收集为基础 在CSCC集中处理的系统。为以下目的开发的软件 试行研究数据管理将成为数据管理的原型 系统将分发到诊所进行更大规模的试验，如果进行， 从而节省了开发时间和成本。还讨论了相关的问题 要设计好中试和主试。

Recent controversy over the risk factor status of elevated lipids and lipoproteins in coronary heart disease morbidity and mortality in elderly adults underscores the need for a properly designed controlled clinical trial testing the effect of cholesterol reduction in this population. HMG CoA reductase inhibitors are effective cholesterol-reducing agents with minimal adverse effects and would serve well as the drug class of interest. This proposal would establish at the University of North Carolina's Collaborative Studies Coordinating Center (CSCC) a coordinating center for a pilot study testing the feasibility of a larger trial of HMG CoA reductase inhibitors in elderly persons. The CSCC proposes to: (a) collaborate with investigators in the design of a cost-effective study protocol; (b) lead in the creation of appropriate data collection instruments; (c) provide administrative support (e.g. meetings arrangements and minutes, central communication, manuscript production); (d) develop and implement a data management system; (e) train clinic staff, write a detailed manual of operations, and provide clinic support (e.g. protocol interpretation) during the study; (f) monitor and maintain data quality at clinics and laboratories; (g) produce statistical reports for investigators and monitoring board; and (h) coordinate publication efforts. Specific plans for meeting these aims, as well the CSCC's experience in such activities for other collaborative cardiovascular research, are detailed. It is suggested that the pilot study be a paper-based data collection system with centralized processing at the CSCC. Software developed for pilot-study data management will be a prototype for a data management system to be distributed to clinics for the larger trial, if conducted, thus saving development time and costs. Also discussed are issues pertinent to the design of the pilot and main trial.