Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease.

BACKGROUND: Both lipid-modifying therapy and antioxidant vitamins are thought to have benefit in patients with coronary disease. We studied simvastatin-niacin and antioxidant-vitamin therapy, alone and together, for cardiovascular protection in patients with coronary disease and low plasma levels of HDL. METHODS: In a three-year, double-blind trial, 160 patients with coronary disease, low HDL cholesterol levels and normal LDL cholesterol levels were randomly assigned to receive one of four regimens: simvastatin plus niacin, vitamins, simvastatin-niacin plus antioxidants; or placebos. The end points were arteriographic evidence of a change in coronary stenosis and the occurrence of a first cardiovascular event (death, myocardial infarction, stroke, or revascularization). RESULTS: The mean levels of LDL and HDL cholesterol were unaltered in the antioxidant group and the placebo group; these levels changed substantially (by -42 percent and +26 percent, respectively) in the simvastatin-niacin group. The protective increase in HDL2 with simvastatin plus niacin was attenuated by concurrent therapy with antioxidants. The average stenosis progressed by 3.9 percent with placebos, 1.8 percent with antioxidants (P=0.16 for the comparison with the placebo group), and 0.7 percent with simvastatin-niacin plus antioxidants (P=0.004) and regressed by 0.4 percent with simvastatin-niacin alone (P<0.001). The frequency of the clinical end point was 24 percent with placebos; 3 percent with simvastatin-niacin alone; 21 percent in the antioxidant-therapy group; and 14 percent in the simvastatin-niacin-plus-antioxidants group. CONCLUSIONS: Simvastatin plus niacin provides marked clinical and angiographically measurable benefits in patients with coronary disease and low HDL levels. The use of antioxidant vitamins in this setting must be questioned.

Zinc intake and plasma zinc level are maintained in men consuming cholesterol-lowering diets.

OBJECTIVE: Reduced zinc intake has been reported when cholesterol-lowering diets are adopted. This study examined whether such diets compromise the zinc status of men with hypercholesterolemia. DESIGN: Zinc intake on baseline 4-day food records and baseline plasma zinc levels were compared with intake and levels 12 and 24 months after subjects adopted a low-fat, increased-fiber diet. Dietary fiber intake, supplement use, alcohol intake, and exercise were evaluated as possible confounding variables. SUBJECTS: Subjects were free-living men (n = 365) with baseline cholesterol level above the 75th percentile who were participants in a randomized trial comparing cholesterol-lowering diets with goals of 30%, 26%, 22%, and 18% of energy from fat and 300, 200, 100, and 100 mg cholesterol, respectively. STATISTICAL ANALYSES: Data were analyzed using two sample t tests, multiple linear regression, and analysis of variance. RESULTS: For all subjects combined, mean fat and cholesterol intakes approached or met the guidelines of the National Cholesterol Education Program step 2 diet, with approximately 30 g fiber per day. Density (mg/1,000 kcal) of zinc intake was unchanged from the baseline value. We found a slightly positive relationship between fiber and zinc intakes; no relationship between fiber intake and plasma zinc level; no effect of supplement use (category included all types of supplements), alcohol use, or level of exercise on plasma zinc levels; and no difference by dietary assignment in zinc intake or plasma zinc levels. APPLICATION: Zinc status does not appear to be at risk in adult men who adopt cholesterol-lowering diets. These results may not be generalized to higher-risk population groups or situations in which dietary counseling is less comprehensive.

Changes in vitamin and mineral intakes and serum concentrations among free-living men on cholesterol-lowering diets: the Dietary Alternatives Study.

Nutritional adequacy of diets with 18-30% of calories from fat was investigated in men with elevated serum cholesterol (n = 396) at the end of diet classes and 1 and 2 y later. On 4-d food records, intakes of vitamin A, beta-carotene, folate, vitamin C, magnesium, vitamin B-6, iron, thiamin, and riboflavin increased from baseline whereas niacin, selenium, vitamin E, and zinc decreased. Median zinc intake, 80% of the recommended dietary allowance (RDA) at baseline, decreased to approximately 75% of the RDA, most markedly when intakes of meat, fish, and poultry were limited to 85 g/d. Nutrient densities generally increased. Of the serum nutrients measured, median beta-carotene and vitamin C increased, whereas vitamin B-6, iron, and zinc were unchanged. Below-normal values were fewer for vitamin C and magnesium. Diets similar to the National Cholesterol Education Program Step-Two Diet [less than 7% saturated fatty acids, less than 200 mg cholesterol/d] appeared to provide increased levels of most micronutrients both short and long term to men receiving comprehensive dietary counseling.