Design and baseline data of a pediatric study with rosuvastatin in familial hypercholesterolemia
- Kusters, D Meeike
- Hutten, Barbarba A
- McCrindle, Brian W
- Cassiman, David
- Francis, Gordon A
- Gagne, Claude
- Gaudet, Daniel
- Morrison, Katherine M
- Langslet, Gisle
- Kastelein, John J
- Wiegman, Albert
DOIAbstract
BACKGROUND: Statin therapy is recommended for children with familial hypercholesterolemia (FH), but most children do not reach treatment targets. OBJECTIVE: Here we present the design and results at baseline of the ongoing CHARON study, to evaluate the safety and efficacy of rosuvastatin. METHODS: This study comprises an international 2-year open label, titration-to-goal study in 198 children with heterozygous FH aged 6 to 18 years, with rosuvastatin in a maximum dose of 10 mg (<10 years of age) or 20 mg (older children). In addition, 64 unaffected siblings were enrolled as controls. The primary efficacy outcome is the change from baseline in low-density lipoprotein cholesterol, and the secondary outcome is the change in carotid intima-medi...
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