WILMINGTON, Del., May 16, 2011 /PRNewswire/ -- Children taking medication for attention deficit hyperactivity disorder suffered no more from serious heart problems or heart-related deaths than those who were not taking ADHD medications, according to a study published online today in the journal, Pediatrics.
The study, co-authored by researchers at the University of Pennsylvania and HealthCore Inc., drew data from the largest population—241,417 children and adolescents—studied to date to evaluate cardiovascular problems and death associated with pediatric ADHD medication use. The study also includes records involving both Medicaid and commercially insured children.
Case reports of sudden death in children and adolescents treated with these drugs have led some to worry they might increase the risk of serious cardiovascular events. Previous studies have shown conflicting results.
"We found low rates of cardiovascular events and of cardiovascular-related deaths in those children and adolescents receiving ADHD medications," said lead author Sean Hennessy, PharmD, PhD , an associate professor of epidemiology at the University of Pennsylvania School of Medicine. "For kids who will benefit from ADHD treatment, the potential risk of a cardiovascular event should not dissuade parents or caregivers from giving a child or adolescent these drugs."
The study found no significant increases in rates of sudden death, heart attack and stroke in patients taking ADHD medications compared to those not taking medications.
Researchers used data on children and adolescents from 3-17 years old from a five-state Medicaid database, as well as the HealthCore Integrated Research Database™, which contains historical and current medical and pharmacy claims data from more than 44 million enrollees in Blue Cross and Blue Shield plans across 14 states. The study identified patients ages 3-17 on ADHD medications and tracked their health records during the period they were on the medications.
"A key strength of this study is that the study data reflected experiences of children and adolescents from a wide range of demographic and economic backgrounds –those from families receiving state Medicaid benefits and those from families with private health insurance," said Gregory Daniel, PhD, MPH , HealthCore vice president of government and academic research. "We were also able to combine insurance claims data with medical records to gain much more insight into whether or not risks of severe cardiovascular events and related mortality were elevated."
The study was based on Medicaid records from 1999-2003 and HealthCore Integrated Research Database™ records from 2001-2006, well before a 2008 recommendation from the American Heart Association that an electrocardiogram be performed before starting any child or teenager on stimulant medications. The study showed that the use of ECGs during this study period, before the 2008 recommendation, were very low.
"It is interesting to note the lower incidence of cardiac-related events, especially when you consider that very few patients from this study were screened with an ECG prior to initiating therapy," said Mark J. Cziraky, PharmD, FAHA, HealthCore vice president of industry sponsored research. "This would likely have removed more patients with higher cardiac risks from the pool of patients using ADHD medications, and would have potentially lowered the rate further."
The study was funded by Shire, a manufacturer of ADHD medications.
Other authors of the study included: Hedi Schelleman, PhD; Warren B. Bilker, PhD; Brian L. Strom, MD, MPH; Stephen E. Kimmel, MD, MSCE; Craig Newcomb, MS; and James P. Guevara, MD, MPH, all from the University of Pennsylvania.
HealthCore, based in Wilmington, Del., is the clinical outcomes research subsidiary of WellPoint. HealthCore has a team of highly experienced researchers including physicians, biostatisticians, pharmacists, epidemiologists, health economists and other scientists who study the real-world safety and effectiveness of drugs, medical devices and care management interventions. HealthCore offers insight on how to best use this data and communicates these findings to health care decision-makers to support evidence-based medicine, product development decisions, safety monitoring, coverage decisions, process improvement and overall cost-effective health care. For more information, go to www.healthcore.com.