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Submitted on August 3, 2004
Accepted on January 7, 2005
Hospital for Children and Adolescents, University of Helsinki, Helsinki, Finland; Department of Children and Adolescents, University of Oulu, Oulu, Finland
* To whom correspondence should be addressed. E-mail: marjatta.antikainen{at}hus.fi.
Heterozygous familial hypercholesterolemia (HeFH) is associated with elevated cholesterol levels and early-onset atherosclerosis. We assessed the efficacy and safety up to two years of pravastatin in 19 girls and 11 boys (age range 4.1 to 18.5 yr) with HeFH. Pravastatin was started at 10 mg/d, with a forced titration by 10 mg at 2, 4, 6, 12 months, until the target cholesterol level (
194 mg/dL [5 mmol/L]) was reached. By 2, 4, 6, 12 and 24 months of treatment, the total cholesterol levels had respectively decreased by 19%, 20%, 23%, 27%, and 26%, and the LDL cholesterol levels by 25%, 27%, 29%, 33%, and 32%, when compared with the dietary baseline values. At baseline, 17% patients had lipid deposits (carotid plaque, xanthomas or corneal arcus), and at 1 yr, 27%. The side-effects were mild, and no clinically significant elevations in alanine aminotransferase, creatine kinase, or creatinine were seen. Growth and pubertal maturation remained normal in all subjects. In conclusion, pravastatin treatment was safe and well tolerated. The efficacy in children with slight or moderate hypercholesterolemia was satisfactory, but in children with severe hypercholesterolemia, insufficient.
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