April 8, 2010 — Most children prescribed second-generation antipsychotic (SGA) drug therapy do not undergo recommended blood glucose and lipid screening tests, according to results of a retrospective, new-user cohort study published in the April issue of the Archives of Pediatrics and Adolescent Medicine.
"The findings in children are particularly noteworthy to clinicians," first author Elaine H. Morrato, DrPH, MPH, of University of Colorado at Denver in Aurora, told Medscape Psychiatry.
"There has been a trend toward increasing use of antipsychotics in children, much of it off-label usage but partly spurred by expanded FDA [US Food and Drug Administration]–approved indications for use in pediatric populations. This means that more children are at risk for the metabolic adverse effects of second-generation antipsychotic drugs," Dr. Morrato added.
Fred R. Volkmar, MD, director of the Child Study Center at Yale University School of Medicine in New Haven, Connecticut, who was not involved in the study, echoed these concerns. SGAs "have their uses, but they also have side effects," he told Medscape Psychiatry.
"Obviously, for many reasons today, we are worried about obesity and anything that contributes to it and contributes to risk for diabetes, and [metabolic] screening is something that should be done and is not being done and it's a shame," said Dr. Volkmar, who is also chief of child psychiatry at Children's Hospital at Yale.
Weight gain and metabolic problems are known to complicate SGA medications.
Since 2003, the FDA has required a class warning on product labeling of all SGAs regarding the now well-known risks of hyperglycemia and diabetes mellitus.
In early 2004, the American Diabetes Association (ADA), the American Psychiatric Association, the North American Association for the Study of Obesity, and the American Association of Clinical Endocrinologists issued a joint consensus statement calling for metabolic screening at baseline and regular glucose and lipid screening for all patients receiving these agents, regardless of age.
To estimate metabolic screening rates in children receiving SGA therapy, Dr. Morrato's team analyzed Medicaid claims data from California, Missouri, and Oregon for the period July 1, 2004, through June 30, 2006.
The analysis included 5370 nondiabetic children aged 6 to 17 years who started SGA therapy, including aripiprazole, olanzapine, quetiapine, risperidone, or ziprasidone hydrochloride, in 2005, approximately 1 year after metabolic screening was recommended. The study also included 15,000 nondiabetic control children taking albuterol but not SGA drugs.
The analysis revealed that glucose screening was performed in less than one-third of SGA-treated children (n = 1699, 31.6%; 95% confidence interval [CI], 30.4% – 32.9%). For comparison, 1891 of the control children underwent glucose screening (12.6%; 95% CI, 12.1% – 13.2%).
Lipid testing was performed in only 720 SGA-treated children (13.4%; 95% CI, 12.5% – 14.4%) vs 458 control children (3.1%; 95% CI, 2.8% – 3.3%).
Children with serious and/or multiple psychiatric diagnoses and those who used health care services more intensively had a higher likelihood of undergoing metabolic screening.
Not surprisingly, the incidence of glucose disorders was higher in SGA-treated children (8.9 per 1000; 95% CI, 6.6 – 11.8) compared with albuterol-treated control children (4.9 per 1000; 95% CI, 3.9 – 6.2). The same was true for lipid disorders (9.7 per 1000 SGA-treated children; 95% CI, 7.2 – 12.7; vs 4.6 per 1000 control children; 95% CI, 3.6 – 5.8).
Dr. Morrato points to a study published by Correll and colleagues last year in the Journal of the American Medical Association (2009;302:1765-1773), which measured the cardiometabolic risk of SGA medications during first-time use in children and adolescents. "After only 12 weeks of treatment, the mean weight gain across the different drugs ranged from about 10 to 19 pounds," she noted.
The authors of the accompanying editorial (JAMA. 2009;302:1811-1812) recommended that lower-risk alternatives be considered before prescribing atypical antipsychotic medications in children, she pointed out.
"Children are not normally considered a high-risk group for diabetes and dyslipidemia screening," Dr. Morrato said. "While this perception may be changing as a result of increasing rates of obesity in American youth, it is particularly important for clinicians treating children taking second-generation antipsychotic drugs to be aware of the ADA’s recommendations for baseline and regular glucose and lipid screening."
"Sadly," added Dr. Volkmar, "what it may take is either some very well-publicized malpractice or some other kind of horrendous case to remind [clinicians] what the standard of care is" when it comes to SGA therapy and metabolic screening.
Dr. Morrato has received past research funding from the National Institutes of Health, Pfizer Inc, and Eli Lilly and Company and is a consultant to the FDA. Coauthors on the study have received funding from various drug companies and agencies. Dr. Volkmar has disclosed no relevant financial relationships related to this study.
Arch Pediatric Adolesc Med. 2010;164:344-351.
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Cite this: Rates of Metabolic Screening Remain Low in Children Taking Antipsychotics - Medscape - Apr 08, 2010.
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