Published online August 31, 2005
PEDIATRICS Vol. 116 No. 3 September 2005, pp. 682-688 (doi:10.1542/peds.2004-2090)
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Efficacy and Safety of Lovastatin Therapy in Adolescent Girls With Heterozygous Familial Hypercholesterolemia

Sarah B. Clauss, MD*, Kathryn W. Holmes, MD*, Paul Hopkins, MD, MSPH{ddagger}, Evan Stein, MD, PhD§, Meehyung Cho, PhD||, Ann Tate, MS||, Amy O. Johnson-Levonas, PhD|| and Peter O. Kwiterovich, MD*

* The Johns Hopkins Medical Institutions, Baltimore, Maryland
{ddagger} Cardiovascular Genetics, Salt Lake City, Utah
§ Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio
|| Merck Research Laboratories, Rahway, New Jersey

Objective. The present study was designed to evaluate the lipid-altering efficacy, safety, and tolerability of lovastatin treatment in adolescent girls with heterozygous familial hypercholesterolemia.

Methods. A total of 54 postmenarchal girls, aged 10 to 17 years, were enrolled in a 24-week, double-blind, randomized, placebo-controlled study. After a 4-week diet/placebo run-in period, patients were randomized to 1 of 2 groups: (1) treatment with diet plus lovastatin 20 mg/day for 4 weeks, followed by diet plus lovastatin 40 mg/day for 20 weeks, or (2) diet plus placebo for 24 weeks.

Results. Baseline values of lipids, lipoproteins, and apolipoproteins (apo) were comparable between treatment groups. Lovastatin treatment was efficacious at reducing low-density lipoprotein cholesterol by 23% to 27%, total cholesterol by 17% to 22%, and apo B by 20% to 23% at weeks 4 and 24, respectively. Between-treatment group differences were not statistically significant for triglycerides, very-low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, or apo A-I. Lovastatin was generally safe and well tolerated. There were no clinically significant alterations in vital signs (blood pressure and pulse rate), anthropomorphic measurements (height, weight, and BMI), hormone levels (luteinizing hormone, follicle-stimulating hormone, dehydroepiandrosterone sulfate, estradiol, and cortisol), menstrual cycle length, or tests of liver and muscle function.

Conclusions. Lovastatin offers an efficacious and well-tolerated treatment option for improving lipid profiles in adolescent girls with familial hypercholesterolemia.

Key Words: adolescents • cholesterol • lipids

Abbreviations: CAD, coronary artery disease • TC, total cholesterol • LDL, low-density lipoprotein • HDL, high-density lipoprotein • FH, familial hypercholesterolemia • TG, triglycerides • VLDL, very-low-density lipoprotein • apo, apolipoprotein • ALT, alanine aminotransferase • AST, aspartate aminotransferase • CK, creatine kinase • DHEAS, dehydroepiandrosterone sulfate • FSH, follicle-stimulating hormone • LH, luteinizing hormone • ULN, upper limit of normal • ANOVA, analysis of variance • AE, adverse event

Accepted Dec 9, 2004.




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