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July 20, 2004 — 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.
Editor's Note: The
authors would like to thank Zorg Onderzoek Nederland (Prevention Fund of the
Dutch Government) for initial financial support of this study. Dr. Kastelein is
an established investigator of the Netherlands Heart Foundation. This work was
supported in part by an unrestricted grant from Bristol-Myers Squibb Inc.,
Princeton, N.J. The sponsor had no role in the design and conduct of the study,
in the collection, analysis, and interpretation of the data, or in the
preparation, review, or approval of the manuscript.
Editorial:
Targeting High-Risk Children
In an accompanying editorial, Antonio M.
Gotto, Jr., M.D., D.Phil., of Weill Medical College of Cornell University, New
York, writes that drug therapy may be needed in the majority of children with
familial hypercholesterolemia.
Gotto writes, "...physicians may classify
familial hypercholesterolemia patients as being at high coronary risk and may
begin preventive efforts as early as childhood, with lifestyle therapy as the
foundation of any regimen."
"In conclusion, there are many issues at the
heart of the debate of using pharmaceuticals in young patients. At what point
does the potential risk of therapy outweigh the potential benefit? In the case
of familial hypercholesterolemia, the promise of reducing future cardiovascular
morbidity and mortality, as well as future demands on acute care and more
expensive preventive approaches, would make aggressive treatment of high-risk
young patients a worthwhile long-term initiative. Appropriate targeting of
lifestyle and drug therapies will optimize primary prevention in this group at
demonstrated risk for early disease."
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