Use of statins in children is debated - Los Angeles Times

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Use of statins in children is debated

A recommendation by the American Academy of Pediatrics that those as

young as 8 be aggressively treated with cholesterol-lowering drugs is

creating controversy.

By Alan Zarembo, Los Angeles Times Staff Writer

July 9, 2008

A recommendation from an influential doctors group that some children

as young as 8 be aggressively treated with cholesterol-lowering drugs

has triggered debate over whether there is enough scientific evidence

to justify such a move.

Statins, already among the most widely prescribed drugs, have been

shown to lower the risk of heart disease in certain adults. But there

are no comparable long-term studies for children.

" We don't know the risks and the benefits, " said Dr. Beatrice A.

Golomb, a cholesterol expert at UC San Diego. " We don't really know

the impact of long-term use. "

The authors of the recommendation from the American Academy of

Pediatrics concluded there was enough indirect evidence to suggest

that starting treatment early makes sense in children with very high

levels of cholesterol.

" The process that ends with a heart attack or stroke starts in

childhood, even infancy, " said Dr. Nicolas Stettler, a coauthor and

pediatrician at the Children's Hospital of Philadelphia.

" The longer you slow down the process, the more you delay the

progression, " he said.

The guidelines, released Monday, are in response to the high rate of

obesity among U.S. children and concerns that they could face

increased risk of heart disease as adults.

The guidelines advise cholesterol testing for millions of children

ages 2 to 10 who have a family history of early heart disease or

other risk factors such as obesity or high blood pressure. Under the

guidelines, those 8 and older should be considered for medication if

they have a concentration of LDL, the so-called bad cholesterol,

greater than 190 milligrams per deciliter.

The threshold drops to 160 milligrams per deciliter in children with

a family history of heart disease or more than two other risk

factors. In children with diabetes, the threshold for drug treatment

is 130 milligrams.

Experts said those levels occur only in children with a genetic

predisposition to high cholesterol, including many who are of normal

weight, and that under the guidelines, fewer than 1% of children

would be considered for statins.

Children with these extremely high LDL levels are known to have an

increased risk of heart disease later in life.

But some doctors predicted that the guidelines would lead to the use

of drugs in children with only moderately high cholesterol levels.

" There may be some pressure to start them on drugs to make these

numbers better, " said Dr. B. Newman, an epidemiologist and

pediatrician at UC San Francisco. He also worries that the acceptance

of drug use would shift the focus of treatment away from diet and exercise.

The guidelines, produced by a seven-member panel and published in the

academy's journal, Pediatrics, did not include any disclosures about

the authors' ties to drug makers.

One author, Dr. s, a pediatrician at Cincinnati

Children's Hospital, has acknowledged working as a consultant for

Merck & Co., which markets statins, and Stettler said he has

participated in industry-funded clinical trials of cholesterol drugs.

Dr. Jerold F. Lucey, editor of the journal, said that disclosures

aren't required for academy-issued guidelines since the panels are

already rigorously vetted.

The academy issued a statement saying " there is no involvement by any

commercial entity in the development of any statement or report

emanating from the AAP. "

The editors were " naive in expecting people would swallow those

recommendations without letting us know if the participants had ties

to the companies that make statins, " said Dr. Jerome P. Kassirer, a

professor at Tufts University School of Medicine and a former editor

of the New England Journal of Medicine.

The idea of using cholesterol-fighting drugs in children is not new.

Over the last decade, several clinical trials have shown that

treatment with statins lowers their cholesterol levels.

In one study, children with extreme levels of cholesterol who were

given statins had less thickening in their necks' carotid arteries

than children on a placebo.

" You know what is going to happen to them if you don't treat them, "

said Dr. O. Kwiterovich, a pediatrician and cholesterol expert

at s Hopkins University who was not involved in making the

guidelines. " They get heart attacks in their 30s, 40s and 50s. "

There is no evidence from clinical trials in children that the drugs

are damaging, he said. Growth, maturation and brain chemistry remained normal.

Most of the clinical trials involved teenagers. The authors of the

guidelines settled on 8 as the minimum age for drug therapy because

that was the age of the youngest patients in any clinical trial, Stettler said.

But the studies, the longest of which tracked children for four

years, did not last long enough to show the long-term benefits of

starting treatment earlier -- or the potential harms.

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Sheri Nakken, former R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

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