The age at which lipid-lowering drug therapy should be started in patients with familial hypercholesterolemia and premature coronary disease is not well defined, although there is agreement that drug therapy should be started in such patients if a low-fat diet fails to reduce the low-density lipoprotein (LDL) cholesterol level to below 160 mg per dL (4.2 mmol per L). Pharmacologic intervention is also generally advocated in patients without a family history of premature coronary disease if the LDL level remains above 190 mg per dL (4.9 mmol per L). Bile-acid sequestrants, which have a relatively long history of use in children with familial hypercholesterolemia, are generally the drugs of choice, but these agents do not have a major effect on LDL levels. Stein and colleagues conducted a study to determine if a statin (specifically, lovastatin) is safe and effective in the treatment of adolescent males with heterozygous familial hypercholesterolemia.
A total of 132 boys 10 to 17 years of age were enrolled in the double- blind, placebo-controlled study; 110 completed the 48-week study. In all of the boys, LDL levels (despite dietary measures) had measured at least 189 mg per dL (4.9 mmol per L). All of the subjects had a family history of one parent with similarly elevated LDL levels or of a parent who died as a result of coronary artery disease. Tanner stage was assessed at recruitment and at 24 and 48 weeks after study entry. Height, weight, lipid profile, liver function and diet were monitored periodically throughout the study. Dietary instruction was provided.
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