PEDIATRICS Vol. 89 No. 1 January 1992, pp. 138-142
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Long-term Treatment of Severe Familial Hypercholesterolemia in Children: Effect of Sitosterol and Bezafibrate

M. Becker MD1, D. Staab MD1, and K. Von Bergmann MD2

1 From the Department of Pediatrics, University of Bonn, Federal Republic of Germany
2 From the Division of Clinical Pharmacology, Department of Medicine, University of Bonn, Federal Republic of Germany

Seven prepubertal children (age range 5.3 to 10.8 years) with severe heterozygous familial hypercholesterolemia (serum cholesterol concentration 416 ± 85 mg/dL and low-density lipoprotein [LDL] cholesterol concentration 360 ± 90 mg/dL) were first treated by dietary Intervention, second by sitosterol (3 x 2 g/d), and third by bezafibrate (2 x 200 mg/d). Each treatment period lasted 3 months. Subsequently, a treatment combining half the dose of sitosterol and bezafibrate was administered for the following 24 months. Diet alone reduced total and LDL cholesterol values by 4.5% (not significant) and 6.6% (P < .05), respectively. Sitosterol lowered total and LDL cholesterol values by 17% (P < .05) when compared with diet alone. Compared with sitosterol, bezafibrate produced a more pronounced effect on total and LDL cholesterol values (-18% and -28%, P < .05), and high-density lipoprotein cholesterol concentration increased significantly from 48 mg/dL to 55 mg/dL Combined treatment with half the dose each of sitosterol and bezafibrate was as effective as the higher dose of bezafibrate, and reduction averaged almost 40% and 50% for total and LDL cholesterol values; this lipid-lowering effect persisted for the next 24 months. Laboratory safety parameters and physical examination revealed no obvious side effects. This study indicates that the combination of sitosterol (3 x 1 g/d) plus bezafibrate (1 khgr 200 mg/d) is an alternate, acceptable, safe, and effective therapeutic approach for treatment of severe hypercholesterolemia in children with high-risk familial hypercholesterolemia.

Key Words: familial hypercholesterolemia • cholesterol • sitosterol • bezafibrate • children

Submitted on May 2, 1991
Accepted on July 22, 1991




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