Cholesterol-Lowering Drugs for Children: When Is Enough Enough?

July 20, 2010

By Terry Smiljanich:

Could we really be headed for a future where kids take Lipitor with their Flintstone vitamins? Childhood obesity is an epidemic, but this has the potential of going too far.  A new study in the latest issue of Pediatrics, the leading journal of pediatric medicine, argues that current standards for pediatric cholesterol screening are inadequate, and that universal cholesterol screening of children 8 years and older should be instituted. Children are now being shoved into the spotlight, even though questions still surround the widespread use of cholesterol-lowering statin drugs by adults.

Children, Cholesterol and Cardiovascular Disease

Several past studies have shown that cardiovascular disease (CVD) is a process that can start early in life and slowly progress in severity over time. The main risk factors for CVD are a family history of heart problems, obesity, high blood pressure, high cholesterol levels, and environmental factors such as smoking. Moreover, repeated studies have shown that abnormally elevated cholesterol levels during childhood are associated with an increased risk of CVD in adulthood.

Since children and adolescents have been know to show early signs of systemic changes that can progress into serious CVD problems, the American Academy of Pediatrics since the 1990’s has recommended targeted screening of children for cholesterol testing in order to single out those young patients in need of early help.

Short of invasive methods or expensive procedures such as esoteric imagery (e.g., carotid ultrasonography), simple cholesterol testing remains the most cost effective way of looking for likely future CVD candidates. Coming up with a “one size fits all” list of standards for cholesterol testing is, however, a challenge, especially since what constitutes an abnormal level of cholesterol is highly variable, based on age, gender and ethnicity.

Pediatricians are concerned, however, with what they see as an apparent epidemic of obesity in young children, pointing clearly to increased prevalence of CVD in the future unless the problem is identified and treated at an early stage.

Current Testing Standards for Children

In 1998, the American Academy of Pediatrics Committee on Nutrition issued its recommended standards for cholesterol testing of children. The Committee recommended first a “population” approach, emphasizing education in healthy lifestyles for children, including increased physical activity, lower saturated fat in their diets, more fruits and vegetables, and fewer fruit juices, sweetened foods and salt.

In addition to this population approach, the Committee recommended that selected children should be targeted for cholesterol testing. If a child comes from a family with a history of CVD problems, or if a parent has been tested with high cholesterol, the child should be tested for LDL cholesterol levels (the “bad” cholesterol number). Levels of LDL below 110 are considered normal. An LDL reading between 110 and 129 should trigger concern and parents should pay increased attention to diet and weight control for their child. With an LDL reading of 130 or higher, parents should consider consultation with a professional nutritionist for a more aggressive approach to diet and weight control.

Drug Therapies for Children?

What did the Committee recommend in the way of drug therapy? Here’s where it becomes more controversial. The Committee recommended no drug therapy for children younger than 10 years of age. If a child’s LDL level remains at or above 190, or if the level remains at 160 or above and the child has a family history of CVD, the Committee recommended administering “bile acid-sequestrants” such as Colestipol, which have been shown to reduce cholesterol levels by 10-20% and have no systemic side effects other than some gastrointestinal discomfort.

As for statins, the Committee recognized that most studies had shown such drugs to be safe for children. It did not, however, recommend statin prescriptions for children except in consultation with a lipid specialist.

Universal Testing?

The study in the latest issue of Pediatrics is calling into question this targeted testing approach for children. Looking at the records of over 20,000 West Virginia fifth graders, all of whom had received cholesterol testing.  It found that 71.4% of the students had positive family histories for CVD and thus would already have met the guidelines for cholesterol screening. Of those children meeting the guidelines, 8.3% (1,200 children) were found to have LDL numbers indicating a cholesterol problem, and 1.2% (14) of them were found to have numbers high enough to suggest a need for drug treatment for high cholesterol.

The study went on, however, to look at the test results of those children who had not meet the existing guidelines for targeted testing because they showed no relevant family history of CVD. Of these 5,800, 9.5% (550) had abnormal LDL levels, of which 9 students had levels high enough to warrant drug intervention.

In summary, using just the existing guidelines for which students should be tested for cholesterol levels, a total of nine students would not have warranted cholesterol testing, yet showed tested levels of LDL that indicating the potential need for drug therapy.

Given the fact that nine students with very high LDL numbers, out of a total of 20,000, would have slipped through the screening guidelines, the authors suggest the need for universal cholesterol testing of children, even where no family history indicates the need for it. “The use of universal cholesterol screening would identify all children with severe dyslipedemia [high cholesterol], allowing for proper intervention and follow-up, leading to the prevention of future atherosclerotic disease.”

Criticism

The idea of testing all children for cholesterol levels has come under criticism. Is it really necessary? Although high cholesterol has shown some correlation with increased risks for CVD, there is as yet no solid evidence that lack of identification and treatment of high cholesterol patients leads to increased risks. It is possible that other risk factors (family history, high blood pressure, obesity, etc.) play a prominent role in the development of the disease and that high cholesterol is not a “cause” in and of itself.

A quick look at nighttime television and the ubiquitous ads for Lipitor, Pravachol, Zocor and other statins, will convince you that such drugs constitute a large profit center for Big Pharma. Can you see it coming? More testing of children will inevitably lead to to greater numbers of pediatric prescriptions. Lipitor has already been approved in the United States for use by 10 year olds, and the European Union has approved a chewable, child-friendly version of Lipitor.

Because of the risks associated with the taking of statins, Consumer Reports (in consultation with health care consultants) recommends against the taking of statins by children except in the rarest cases.

The fact remains that the single best way to avoid heart disease, whether you are young or old, is to lead a healthy lifestyle, exercising regularly and eating wisely. Do we really want to teach our children at an early age that taking a pill can help you avoid harder decisions about changing your life style?