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None of the children in the study suffered increases in liver and muscle enzymes attributed to their medication, a major concern with statins. Two boys had temporary increases in muscle enzymes apparently related to their extreme physical exercise. Four patients complained of muscle pain but had no elevated muscle enzymes, Hutten said.

During the average 4.5 years of follow-up, no serious clinical or laboratory adverse events were reported, as well as any untoward effects on sexual maturation or growth, Kastelein said. However, the number of children in our study is not sufficient to appropriately estimate the incidence of adverse events in children on statin treatment.

Optimal age for beginning statin therapy in FH children remains unknown and will require further clinical trials to resolve, Vissers said. We intend to continue to monitor the children in our study as long as possible.

The American Heart Association recommends implementing diet and lifestyle modifications for children with high cholesterol. If needed, a statin, started at the lowest dose, is recommended as the first line of treatment for children who meet criteria for starting lipid-lowering drug therapy.

Currently, lovastatin, simvastatin, pravastatin and atorvastatin have pediatric labeling from the U.S. Food and Drug Administration based on clinical trials performed in children with FH.

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Contact: Cathy Lewis
cathy.lewis@heart.org
214-706-1324
American Heart Association
3-Aug-2007