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The Food and Drug Administration
(FDA) recently approved the first statin drug for use by children. While
it may improve treatment of high blood cholesterol for some, it's also
raising concern about inappropriate use of a powerful drug in kids.
The American Academy of Pediatrics
(AAP) worries that the FDA's
February approval of Merck's Mevacor (lovastatin) -- for children
with a disorder that gives them very high blood cholesterol -- could fuel
more statin use when there is still little long-term safety and efficacy
data in children, said John Moore, a pediatric cardiologist at Philadelphia's
M.C. Hahnemann Medical Center and chairman of the AAP's cardiology section.
There's also no consensus on
how best to treat high cholesterol in youngsters, he said. The academy
is expected to write new guidelines in late July.
The most recent National Cholesterol
Education Program guidelines say drug therapy should be considered in
adults when LDL (or "bad") cholesterol rises above 190, or above
160 when there are two or more risk factors for cardiovascular disease.
The same rules are usually
followed in children, said Stephen Daniels, a pediatric cardiologist at
the Cincinnati Children's Hospital Medical Center. There are no good figures
on how many children have dangerous LDL levels, but the American Heart
Association estimates that 10 percent of children aged 12 to 19 have high
total cholesterol levels -- above 200.
Daniels predicted most pediatricians
will be circumspect in prescribing Mevacor for children. "My guess
is that there's not going to be an explosion in usage," he said.
But others, like Moore, are less certain.
Mevacor was approved specifically
for children aged 10 to 17 who have heterozygous familial hypercholesterolemia
(HFH), an inherited condition that affects one in 500 Americans and puts
them at very high risk for early heart disease and death.
But "off-label" use
of statins for uses beyond those for which they are specifically approved
is common. Many pediatric cardiologists use statins already to lower cholesterol
in children, and it's possible that the approval of Mevacor for children
will open the door to wider pediatric use for children with milder cholesterol
problems.
In Merck's two studies of boys
and girls with HFH, Mevacor cut cholesterol by 25 to 30 percent -- "on
par with what we see in adults," said David Orloff, director of FDA's
division of metabolic and endocrine drugs. But because the trials were
short-term -- boys were studied for one year, girls for six months --
it is not known if Mevacor will slow the progression of heart disease
in children or have unforeseen side effects.
Pete Kwiterovich, director
of the University Lipid Clinic at Johns Hopkins University Medical Center
and lead investigator in both trials, said the drug showed no evidence
of two common statin effects -- liver and muscle damage.
Mevacor also did not appear
to affect growth or sexual development during the period of study -- both
particular concerns, since cholesterol plays a key role in growth and
sex hormone synthesis.
Mevacor for children is the
same formulation as the adult product but in a lower dose -- up to 40
milligrams a day, half that used in adults. Since the drug lost its patent
protection last year, cheaper generics have become available. But the
approval for use in children permits Merck to market the brand-name drug
for that use, something the other statins, including the generics, may
not do.
Washington
Post, May 7, 2002; Page HE03
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