A total of 429 subjects (79 women and 350 men), aged 35-75 years, have been enrolled in a randomized clinical trial of fluvastatin therapy for hypercholesterolemia. The progression and regression of atherosclerotic lesions will be assessed by quantitative angiography and positron emission tomography (PET) after 2.5 years of treatment. Patients were included in the trial if they had angiographically documented lesions that occluded 30-75% of the diameter of a major coronary vessel. Of the 429 subjects, 99 were also studied by PET at rest and during static exercise of sustained handgrip combined with administration of dipyridamole. All subjects were instructed in an American Heart Association/ National Cholesterol Education Program (AHA/ NCEP) Step I or Step II diet. Of the total, 107 subjects (25%) had low density lipoprotein cholesterol (LDL-C) ≥160 mg/dL and were given cholestyramine, 8 g/day. All subjects were randomized to placebo or fluvastatin, the newest 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor to be introduced into the U.S. market. Fluvastatin is entirely synthetic and is similar in efficacy to the other available HMGCoA reductase inhibitors. Its pharmaceutical profile (i.e., low systemic exposure) makes fluvastatin a good candidate for use in combination lipid-lowering therapy. The majority of subjects were recruited through a community campaign and the remainder through cardiac catheterization laboratories and the medical records of hospitals in the Texas Medical Center. Approximately 8,500 prospects from the community campaign were screened and 272 were randomized, a conversion rate of approximately 3%. Approximately 42,000 prospects from hospital sources were screened and 157 were randomized, a conversion rate of approximately 0.4%. The number of qualified lesions of a major coronary artery (30-75% diameter stenosis) in each subject averaged 2.8 (mode, 2; range, 1-9), and 247 subjects (48% of the women and 60% of the men) had at least 1 lesion of moderate severity (50-75% diameter stenosis). Of the subjects, 196 (49% of the men and 30% of the women) had undergone percutaneous transluminal coronary angioplasty or had 100% occlusion of one coronary artery, or had both in the same major coronary artery. Men had more severe disease according to history of angioplasty or presence of 100% occlusion in 1 major coronary artery. This relation was seen best in subjects who were not eligible for cholestyramine treatment. No association was seen between sex and number of qualified lesions. Moreover, there were no differences in the severity of coronary artery disease in relation to age. Male sex was related to amount of obstruction rather than number of qualified lesions.
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine