CHICAGO – Two years of therapy with the cholesterol-lowering drug pravastatin induced significant regression of carotid artery wall thickness, and significantly reduced "bad" cholesterol among children with an inherited type of high cholesterol, with no apparent adverse effects on growth, sexual maturation, hormone levels, or liver and muscle tissue, according to a study in the July 21 issue of The Journal of the American Medical Association (JAMA).
According to background information in the article, familial hypercholesterolemia is a disorder characterized by markedly elevated levels of low-density lipoprotein cholesterol (LDL-C) from birth onward. Children with familial hypercholesterolemia have endothelial dysfunction (impairment of the blood vessel's ability to respond to changes in blood flow by expanding or contracting) and increased carotid intima-media thickness (IMT, increased thickness of the wall of the carotid artery). Endothelial dysfunction and carotid IMT are linked with premature atherosclerotic disease later in life. Atherosclerosis is the build-up of fat and cholesterol deposits, called plaque, in the arteries. The long-term efficacy and safety of cholesterol-lowering medication have not been evaluated in children.
Albert Wiegman, M.D., Ph.D., of the University of Amsterdam, and colleagues conducted a randomized, double-blind, placebo-controlled trial to determine the two-year efficacy and safety of pravastatin therapy in children with familial hypercholesterolemia. Pravastatin belongs to the class of drugs known as statins, which lower cholesterol by blocking the enzyme in the liver that is responsible for making cholesterol. The study included 214 children, aged eight to 18, who were recruited between December 1997 and October 1999, and followed up for two years. After initiation of a fat-restricted diet and encouragement of regular physical activity, 106 children were randomly assigned to receive treatment with 20 to 40 milligrams per day of pravastatin, and 108 were assigned to receive a placebo tablet.
"Compared with baseline, carotid IMT showed a trend toward regression with pravastatin, whereas a trend toward progression was observed in the placebo group," the authors report. "The mean change in IMT compared between the two groups was significant."
Children who received pravastatin showed an average 24.1 percent reduction in LDL cholesterol levels, while those who received placebo showed an average 0.3 percent increase in LDL-C.
No differences between the two groups were observed in growth, maturation, hormone levels, or muscle and liver enzymes.
"We were able to show that statin treatment improved the lipoprotein profile toward more physiological levels and we observed regression of carotid IMT," the authors conclude. "This shows that the increased arterial wall thickness progression found in children with familial hypercholesterolemia is reversible."
"Although this trial in children with familial hypercholesterolemia has, to our knowledge, the most extensive follow-up to date, data on even longer-term safety and efficacy of statin therapy in children are needed," they write. (JAMA.2004; 292:331-337. Available post-embargo at JAMA.com)
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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