Pravastatin Safe in Children With Hypercholesterolemia

Children with familial hypercholesterolemia age 4 or older can safely be treated with pravastatin. A satisfactory reduction in total and LDL-cholesterol can be expected in those with slight or moderate but not severe hypercholesterolemia.

Dr. Marjatta Antikainen of the University of Helsinki notes that, Individuals with heterozygous familial hypercholesterolemia are at increased risk for early-onset atherosclerosis and dietary interventions aimed at normalizing cholesterol levels have proven insufficient.

They assessed the safety and efficacy of pravastatin therapy for up to 2 years in 19 girls and 11 boys between 4 and 18 years old with heterozygous familial hypercholesterolemia.

The subjects were assigned to a diet low in fat, saturated fat, and cholesterol coupled with plant stanol or sterol ester supplementation. After 2 months pravastatin treatment was started at 10 mg/d titrated to a maximum dose of 50 mg/d or until a target of cholesterol level of 194 mg/dL or lower was reached.

Treatment with pravastatin also progressively lowered total and LDL-C, they also report. By 2, 4, 6, 12, and 24 months of treatment, total cholesterol levels had fallen by 19%, 20%, 23%, 27%, and 26%, respectively, while LDL-C had fallen by 25%, 27%, 29%, 33%, and 32%, compared with dietary baseline values.

According to the investigators, roughly 70% to 80% of the maximum total and LDL-C reductions were achieved with 10 to 20 mg/d pravastatin.

Importantly, it was noted that, "pravastatin was well tolerated without any significant side effects. Pravastatin did not influence normal growth and development or pubertal maturation."

In the current study, 17% of the children had lipid deposits (carotid plaque, xanthomas, or corneal arcus) at baseline and 27% had deposits at 12 months, "suggesting that the development of atherosclerosis in heterozygous familial hypercholesterolemia may start even before puberty," the investigators write.

Thus, early statin therapy "seems crucial" in these children for primary prevention of coronary heart disease, they conclude.
J Clin Endocrinol Metab 2005;90:1942-1952.

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