A RANDOMIZED TRIAL TO ASSESS EFFECTIVENESS AND COST IN CLINICAL-PRACTICE - RATIONALE AND DESIGN OF THE CHOLESTEROL REDUCTION INTERVENTION STUDY (CRIS)

To compare the effectiveness and costs of two alternative approaches t o the treatment of hypercholesterolemia, a prospective randomized tria l is being undertaken at Southern California Kaiser Permanente, a larg e health maintenance organization. Six hundred and twelve patients wit h postdiet LDL cholesterol (LDL-C) levels in the range of 190-230 mg/d l (or 160-230 mg/dl for those with coronary heart disease or two or mo re coronary risk factors) were randomized to a stepped-care regimen (i nitial treatment with niacin followed by other agents if needed) or to initial use of lovastatin, an HMG-CoA reductase inhibitor. All patien ts are being followed for 1 year. The study seeks to approximate condi tions of typical clinical practice: provider compliance with these pla ns of treatment is encouraged but not enforced and patients pay for me dication as they customarily would. Principal outcomes of interest inc lude the proportion of participants who achieve goal LDL-C at one year , the mean change in total cholesterol and LDL-C levels between baseli ne and the end of follow-up, and the costs of cholesterol-lowering the rapy.