HMG COA REDUCTASE INHIBITORS IN THE ELDERLY

这个项目的目的是帮助设计和执行一个 一项多中心随机临床试验的试点研究 是否在60岁后降低升高的血清胆固醇水平 一种新型的有效降胆固醇药物，3-- 羟基-3-甲基戊二酰辅酶A(HMG CoA)还原酶抑制剂，将 降低动脉粥样硬化性心血管疾病的死亡率。这个 试点研究的目的是确定进行 在大约5600人中对开发的设计进行了长期试验。 当地对试点研究的参与将包括：第一阶段 西北血脂研究诊所的研究人员和 医学、流行病学、精神病学和行为科学 华盛顿大学将为科学设计和 执行协作协议；第二阶段将涉及主题 招募和实施第一阶段设计的议定书。 受试者，年龄60-75岁，将从团体健康合作社招募 普吉特湾，当地一家大型健康维护组织。科目 谁的低密度脂蛋白胆固醇等于或大于160毫克/分升将被指示在 低脂肪、低胆固醇饮食，并重新筛查是否有较高的低密度脂蛋白胆固醇 在两个月的饮食治疗后。将随机抽取500名符合条件的受试者 在双盲的情况下接受安慰剂或药物。科目 将通过诊所访问进行跟踪，直到第二阶段结束，或 直到全面试验结束，如果认为可行的话。在基线和 在第二阶段的6次后续访问中，受试者将抽血 用于脂蛋白、脂质和药物毒性测量；将评估 健康状况、生活方式和用药情况；并将接受饮食 加强、评估和药物依从性咨询。冠脉心脏 与疾病相关的发病率和死亡率，以及所有原因死亡率数据将 在后续的整个过程中被收集。

The purpose of this project is to assist in thedesign and performance of a pilot study for a multicenter randomized clinical trial to determine whether lowering elevated serum cholesterol (C) levels after age 60, by use of one of a new class of potent cholesterol-lowering drugs, the 3-- hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitors, will reduce mortality due to atherosclerotic cardiovascular disease. The objective of the pilot study is to determine the feasibility of conducting a long-term trial of the developed design in approximately 5600 persons. Local participation in the pilot study will consist of: Phase 1 in which investigators at the Northwest Lipid Research Clinic and the Departments of Medicine, Epidemiology, and Psychiatry and Behavioral Sciences at the University of Washington will contribute to the scientific design and implementation of the collaborative protocol; Phase 2 will involve subject recruitment and implementation of the protocol designed in Phase 1. Subjects, age 60-75 years, will be recruited from Group Health Cooperative of Puget Sound, a large local health maintenance organization. Subjects whose LDL-C is equal to or greater than 160 mg/dL will be instructed in a low-fat, low-cholesterol diet and rescreened for an elevated LDL-C value after two months of diet therapy. 500 eligible subjects will be randomized to receive either a placebo or drug in a double-blind nature. Subjects will be followed via clinic visits until either the end of Phase 2, or until the end of a full scale trial, if deemed feasible. At baseline and during 6 follow-up visits during Phase 2, subjects will have blood drawn for lipoprotein lipid and drug toxicity measurements; will be evaluated for health status, lifestyle and medication use; and will receive diet reinforcement, assessment, and drug compliance counseling. Coronary heart disease related morbidity and mortality, and all cause mortality data will be collected throughout the follow-up.