Efficacy and safety of atorvastatin in children and adolescents with familial hypercholesterolemia or severe hyperlipidemia: a multicenter, randomized, placebo-controlled trial.

Abstract

OBJECTIVE:

To determine the safety and efficacy of atorvastatin (10 to 20 mg) in children and adolescents with familial hypercholesterolemia or severe hypercholesterolemia.

STUDY DESIGN:

Subjects (n=187) were randomly assigned to 26 weeks of treatment with atorvastatin (10 mg) or placebo. Dosage was increased to 20 mg if LDL cholesterol (LDL-C) levels remained >3.4 mmol/L (130 mg/dL) at week 4. At week 26, subjects received 10 mg of atorvastatin for an additional 26 weeks. Efficacy variables included percent changes in LDL-C, total cholesterol, triglycerides, HDL cholesterol, and apolipoprotein B from baseline to week 26.

RESULTS:

Atorvastatin caused a highly significant reduction in LDL-C compared with placebo (-40% vs -0.4%, respectively; P<.001). Percent changes at week 26 also significantly favored atorvastatin for total cholesterol (-32% vs -1.5%; P<.001), triglycerides (-12% vs +1.0%; P=0.03), and apolipoprotein B (-34% vs +0.7%; P<.001), with a significantly greater increase in HDL cholesterol with atorvastatin compared with placebo (+2.8% vs -1.8%; P=.02). Atorvastatin was as well-tolerated as placebo.

CONCLUSIONS:

Treatment with atorvastatin for 12 months was effective and safe for pediatric subjects with known familial hypercholesterolemia or severe hypercholesterolemia.

• Authors: Brian W McCrindle, Leiv Ose, A David Marais
• Journal: The Journal of pediatrics (J Pediatr) Vol. 143 Issue 1 Pg. 74-80 (Jul 2003) ISSN: 0022-3476 [Print] United States
• PMID: 12915827 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Apolipoproteins B
• Cholesterol, HDL
• Cholesterol, LDL
• Heptanoic Acids
• Hypolipidemic Agents
• Pyrroles
• Triglycerides
• Atorvastatin

Topics

• Adolescent
• Adult
• Apolipoproteins B (blood)
• Atorvastatin
• Child
• Cholesterol, HDL (blood)
• Cholesterol, LDL (blood)
• Double-Blind Method
• Female
• Heptanoic Acids (adverse effects, therapeutic use)
• Humans
• Hypercholesterolemia (blood, drug therapy, genetics)
• Hyperlipidemias (blood, drug therapy, genetics)
• Hypolipidemic Agents (adverse effects, therapeutic use)
• Male
• Pyrroles (adverse effects, therapeutic use)
• Severity of Illness Index
• Triglycerides (blood)