HMG COA REDUCTASE INHIBITORS IN THE ELDERLY

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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.