The primary purpose of this pilot randomized trial of HMG CoA Reductase Inhibitors (HMGCRI) in the elderly is to test the feasibility of mounting a national multicenter randomized clinical trial of the impact of lowering low density lipoprotein (LDL) levels on subsequent cardiovascular mortality. The purpose of the feasibility study is to test: cost-effective recruitment strategies, recruitment yields, compliance and adherence with the medication and protocol, rates of adverse events and dropouts, and current assumptions regarding the efficacy of lovastatin on LDL levels in elderly persons.

This proposed clinical center would recruit and enroll 180 participants within 9 months and also recruit 400 participants for the full-scale trial (if it occurs). Recruitment will be based on two strategies with alternative strategies available. The primary strategy will consist of a mass mailing of letters and brochures to 50,000-60,000 age eligible persons. The secondary strategy will consist of community screening and screening of blood donors. Approximately 50-100 persons per week would be screened at community sites where elderly persons congregate.

Proposed inclusion criteria include males and females aged 65-80 with an average LDL after dietary intervention of 160-200 mg/dl. Participants would be randomized to lovastatin or its identical placebo. The treatment goal would be an LDL of 90-120 mg/dl. Initial lovastatin dose would be 20 mg once a day, increasing in 8 weeks to 40 mg a day if goal is not reached. Staff and participants would be blinded to study lipid levels. An identical proportion of the placebo group would randomly be increased to a second step placebo to maintain the blind.

This clinical center has sophisticated methods and protocols for tracking and monitoring adherence and compliance. Detailed methods and protocols would be developed for patient scheduling and follow-up, data collection and timely transmission, staff training and certification, handling and analysis of lipid specimens, and quality control on all study procedures. The investigators would participate in all national planning and monitoring activities and are prepared to implement any protocol designed by the steering committee.

U01HL044298

1990-07-01

1992-06-30