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U.S. Food and Drug Administration Approves CRESTOR(R) for Use in Pediatric Patients With Heterozygous Familial Hypercholesterolemia
Date:10/16/2009

iatric population.

About Heterozygous Familial Hypercholesterolemia

Heterozygous familial hypercholesterolemia affects 10 million people worldwide(1) and is most commonly caused by a defect in the LDL-C receptor gene that leads to elevated LDL-C levels. The American Academy of Pediatrics states that pharmacological intervention should be considered for children with LDL levels greater than 190 mg/dL.

About PLUTO

The PLUTO (Pediatric Lipid-redUction Trial of rOsuvastatin) study was a 12-week, double-blind, randomized multicenter, placebo-controlled study with a 40-week, open-label follow-up. The PLUTO study was designed to evaluate the efficacy and safety of CRESTOR in children ages 10-17 with heterozygous familial hypercholesterolemia (HeFH), a genetic disease characterized by high LDL cholesterol (the "bad" cholesterol) and early cardiovascular disease.

About CRESTOR (rosuvastatin calcium):

Studies have previously shown that CRESTOR, as an adjunct to diet in adult patients, significantly lowered LDL-C, had a significant effect on raising HDL-C and slowed the progression of atherosclerosis, an underlying cause of cardiovascular disease.

CRESTOR is indicated as an adjunct to diet to reduce elevated Total-C, LDL-C, ApoB, non-HDL-C, and TG levels and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. CRESTOR is also approved for pediatric patients 10 to 17 years of age with heterozygous familial hypercholesterolemia (HeFH) after failing an adequate trail of diet therapy. CRESTOR is also indicated as an adjunct to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels. CRESTOR is not approved to reduce cardiovascular morbidity and mortality.

CRESTOR has now recei
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SOURCE AstraZeneca
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