Cholesterol Drug Crestor Approved for Children

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The U.S. Food and Drug Administration (FDA) has approved the use of Crestor, generic name rosuvastatin, for lowering cholesterol for children and teens with a specific type of inherited condition. The medication is currently approved for use in adults to lower cholesterol levels.

Heterozygous Familial Hypercholesterolemia (HeFH) is characterized by dangerously high LDL cholesterol levels and increases the risk of developing early onset heart disease. It affects about 1 in 500 people. According to a 2006 study from the Canadian Medical Association Journal, as many as 30% of patients with HeFH do not survive their first myocardial infarction.

In familial hypercholesterolemia, the liver’s ability to catabolize (breakdown) LDL cholesterol is impaired. The “bad” cholesterol is prolonged in the bloodstream, and the particles can oxidize and form deposits inside the arterial walls, causing premature cardiovascular disease, stroke and peripheral vascular disease. The risk of this occurring is easily treated with methods that reduce LDL cholesterol, such as diet and medication.

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The major signs and symptoms of familial hypercholesterolemia include:

• High levels of total cholesterol (TC) and LDL cholesterol
• A strong family history of high levels of TC and LDL and/or early heart attack
• Elevated and therapy-resistant levels of LDL in either or both parents
• Xanthomas – waxy deposits of cholesterol in the skin or tendons
• Xanthelasmas – cholesterol deposits around in the eyelids
• Corneal arcus – cholesterol deposit around the cornea of the eye

The approval of the statin drug, made by AstraZeneca, came after successful results from the Pediatric Lipid Reduction Trial of Rosuvastatin (PLUTO) which completed Phase III clinical trials in May 2009.

Guidelines for physicians will recommend the medication only be prescribed for children 10 to 17 years old after diet therapy has failed to lower LDL cholesterol.

Sources Include: ClinicalTrials.gov, Genome.gov, and the Canadian Medical Association

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Comments

Although familial hypercholesterolemia is a very serious condition, the use of statins in children scares me, given the potential side effects of the drug.