The FDA has approved Crestor (rosuvastatin calcium tablets, from AstraZeneca) for use in pediatric patients 10–17 years of age with heterozygous familial hypercholesterolemia (HeFH) after failing an adequate trial of diet therapy. This approval was based on data from the PLUTO (Pediatric Lipid-redUction Trial of rOsuvastatin) study, a 12-week, double-blind, randomized, multicenter, placebo-controlled clinical trial with a 40-week open-label follow-up designed to evaluate the efficacy and safety of Crestor in children 10–17 years old with HeFH.
Crestor is already 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 adults with primary hyperlipidemia and mixed dyslipidemia. 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.
For more information call (800) 237-8898 or visit www.crestor.com.