Cholesterol drugs for children

A study in the Journal of the American Medical Associaion on statin treatment of children with familial hypercholesterolemia found pravastatin was effective in reducing cholsterol levels with no adverse effects unique to adolescents or children.

Further update: In March 2009 Journal Watch Pediatrics and Adolescent Medicine concluded that the percentage of adolescents who should get statins, or any medical treatment for hyperlipidemia, is small. Approximately 200,000 kids age 12 to 17 would be eligible under the guidelines.

Update Feb 2009: A medical officer in the U.S. Public Health Service published a study in the journal Circulation concluding that less than 1% of kids aged 12 to 17 need statins. Dr. Earl S. Ford examined epidemiological information on teen LDL cholesterol levels. The American Academy of Pediatrics guidelines recommend statins for children with LDL readings about 190 (over 160 for those with certain risk factors such as diabetes), but only 0.8% of American kids meet this criteria.

In July 2008, the American Academy of Pediatrics issued recommendations on screening overweight children for high cholesterol, and recommended statin drugs for children as young as 8 years old, when the risks are high. The AAP said all children should be tested at least once between the ages of 2 and 10 if they have a family history of obesity, high blood pressure, or diabetes.

No studies have ever concluded that children face any more risk from statins than adults do. There are always risks and side effects with statins, but the AAP, the most influential children's health group, concludes that diet therapy be used for kids with

American Heart Association Scientific Statement

March 21, 2007– New data and a better understanding of the beginnings of heart disease have made it necessary to update guidelines on treating children with high-risk lipid abnormalities, particularly high cholesterol, according to an American Heart Association scientific statement published in Circulation: Journal of the American Heart Association.

While lifestyle modifications such as exercise and diet remain the best ways to address high cholesterol in most people, just as with adults there are certain risk factors in children that may call for more aggressive treatment.

“Guidelines drawn up by the National Cholesterol Education Program (NCEP) more than 10 years ago didn’t really address the use of statins, a class of drugs that can lower cholesterol,” said Brian McCrindle, M.D., head of the statement writing group. “Since that time, several drug trials in kids with familial hypercholesterolemia, a genetic predisposition to high cholesterol, have shown the use of statins had similar safety and effectiveness as in adults.

“In addition to highlighting newer evidence, this new statement addresses a greater need for recognizing young patients with multiple risk factors and how those factors could influence the decision to treat with medications or not,” added McCrindle, professor of pediatrics at the University of Toronto and staff cardiologist at Toronto’s Hospital for Sick Children.

The new statement will specifically affect children and adolescents with high-risk lipid abnormalities, such as those with familial hypercholesterolemia, diabetes, or a family history of cardiovascular disease or early heart attacks and stroke.

Children who are overweight or obese may have higher-than-average cholesterol levels, but they usually wouldn’t meet the criteria for taking cholesterol-lowering drugs, said McCrindle. Lifestyle changes would be the most appropriate treatment focus in those children.

The statement notes there is now definitive evidence that the atherosclerotic disease process (the building up of plaque on artery walls) begins in childhood, and the rate of progression is greatly increased by lipid abnormalities and their severity.

While current safety and effectiveness data is only short-term (based on one-to-two years of treatment), “if you lower cholesterol in these kids, you can improve the function of their arteries and reverse early atherosclerotic change,” McCrindle said.

The original NECP guidelines had more stringent criteria for beginning drug treatment and recommended bile-acid binding resins, a class of drugs that lower cholesterol but aren’t as effective or as well tolerated as statins.

The American Heart Association statement recommends statins as first-line treatment for children who meet criteria for starting lipid-lowering drug therapy. Currently, lovastatin, simvastatin, pravastatin and atorvastatin have pediatric labeling from the U.S. Food and Drug Administration based on clinical trials performed in children with familial hypercholesterolemia.

The previous guidelines made several assumptions that newer research has challenged. For example, the NCEP panel estimated that 25 percent of children and adolescents would be targeted for cholesterol screening. However, based on a number of population-based studies, from 36 percent to 46 percent of children and adolescents would be targeted.

Also, in setting the criteria for when screening should be conducted, the earlier guidelines didn’t consider variability in total cholesterol and high-density lipoproteins (HDL or “good”) cholesterol levels based on race, gender and sexual maturation. For example, black children tend to have higher total cholesterol levels but also higher levels of HDL cholesterol; girls tend to have higher total cholesterol levels than boys; and overall cholesterol levels tend to be higher during the pre-pubertal period than during puberty.

Highlights of the American Heart Association statement include:

• In addition to family history, overweight and obesity should trigger screening with a fasting lipid profile.
• Overweight and obese children with lipid abnormalities should be screened for other aspects of the metabolic syndrome, a condition characterized by a group of specific risk factors (i.e. excess body weight, high blood pressure, elevated triglycerides, low levels of HDL cholesterol and high fasting glucose levels.)
• Lifestyle modifications should be implemented for most children, but if needed, a statin, started at the lowest dose, is recommended as the first line of treatment for children who meet criteria for starting lipid-lowering drug therapy, if there are no contraindications.
• For children with high-risk lipid abnormalities, the presence of additional risk factors or high-risk conditions may also lower the recommended level of LDL “bad” cholesterol at which drug therapy should be started and lower the desired maintained target level of LDL cholesterol. These high risks may include: male gender, strong family history of premature cardiovascular disease or events, presence of associated low HDL, high triglycerides, small dense LDL, presence of overweight or obesity and aspects of the metabolic syndrome, and presence of other medical conditions associated with an increased atherosclerotic risk.

The statement also includes advice on monitoring young patients as they grow. McCrindle says cholesterol levels can vary daily, as seasons change and with changes in physical and sexual development (puberty). Guidelines for monitoring children include keeping track of height, weight, body mass index and the onset of puberty, as well as monitoring fasting lipoprotein profile every six to 12 months.

Looking forward, the writing group says, “There is a real need for ongoing research regarding drug therapy of high risk lipid abnormalities in children, particularly regarding long-term efficacy and safety, and impact on the atherosclerotic disease process.”

Co-authors of the statement are: Elaine M. Urbina, M.D.; Barbara A. Dennison, M.D., FAHA; Marc S. Jacobson, M.D., FAHA; Julia Steinberger, M.D., M.S.; Albert P. Rocchini, M.D., FAHA; Laura L. Hayman, Ph.D., R.N., FAHA and Stephen R. Daniels, M.D., Ph.D., FAHA.

Source: American Heart Association