Wednesday, July 21, 2004
An expert said the report leaves many questions unanswered.
LONG ISLAND NEWSDAY
NEW YORK -- Statin drugs, taken by more than 30 million adults, also work well reducing high levels of the bad form of cholesterol in children who have an inherited condition that sharply increases cholesterol levels, researchers report in a study released today.
Aware of the paucity of options available for children with familial hypercholesterolemia -- a disorder in which cholesterol's bad form soars -- a team from the University of Amsterdam wanted to know if statin therapy would prevent arterial blockages that lead to heart attacks and strokes.
Reporting in today's Journal of the American Medical Association, Dutch researchers found that not only did statin treatment reduce levels of low-density lipoprotein -- LDL -- it also helped clear arteries that were becoming increasingly blocked by plaque. Cholesterol levels dropped 24 percent in children ages 8 to 18 who took pravastatin for two years. The drug, a product of Bristol-Myers Squibb, is sold as Pravachol.
Dr. Albert Wiegman and his team reported pravastatin had no adverse effects on growth, sexual maturation, hormone levels or liver or muscle tissue.
Wiegman put the 204 children -- boys and girls -- on a low-fat diet for three months, before they underwent statin therapy. Their average LDL cholesterol level was 239, more than 100 points above accepted levels. After dieting, children received pravastatin or a placebo. Those on pravastatin experienced a 57-point decline in their LDL levels; those on dummy pills remained essentially unchanged.
Familial hypercholesterolemia, which affects about one in 500 children worldwide, is so devastating that people affected by it generally die young of cardiovascular disorders.
Dr. Edward Fisher, a professor of cardiovascular medicine and pediatrics at New York University, said the study's findings are intriguing because there are so few options for youngsters with the disease.
"I am personally convinced that in a child with FH, the clock starts ticking on his arteries very early in life and the lifetime risk will certainly be reduced with early intervention."
Fisher said previous studies of statin therapy in children tended to be of shorter duration, but even this one, running two years, still leaves many questions unanswered. He said pediatric heart specialists are divided over long-term drug therapy even for children with an inherited disease.
Catherine Tom, a pediatric pharmacologist at Montefiore Medical Center in the Bronx, said no one knows what side effects may be associated with longer-term therapy.