Two-Drug Therapy Helped Kids With Type 2 Diabetes
However, Avandia (rosiglitazone) was recently linked to an increased risk of heart attack and stroke, so it may not be the best drug for these young patients, experts say.
"Many kids with type 2 have a rapidly progressive disease requiring early onset of insulin therapy, and current approaches to oral therapy may be inadequate," said lead researcher Dr. Philip Zeitler, a professor of medicine at the University of Colorado, Denver.
Zeitler noted that the choice of Avandia as a companion medication was made in 2002, before the cardiac problems with the drug were known.
"Given the problems with rosiglitazone, we are not recommending it at this time," he said. "However, no problems with rosiglitazone have been noted in [the study participants] to date, though the cohort size is too small for a thorough safety analysis."
The report was published online April 29 in the New England Journal of Medicine, to coincide with a planned presentation of the finding at the Pediatric Academic Societies' annual meeting in Boston. The National Institute of Diabetes and Digestive and Kidney Diseases funded the research.
For the study, almost 700 obese children, aged 10 to 17, with type 2 diabetes were randomly assigned to metformin alone, metformin plus Avandia or metformin along with intensive lifestyle changes in diet and exercise.
Over the course of 46 months, the researchers found that metformin alone did not adequately control blood sugar levels in 51.7 percent of patients. Among those who received metformin and lifestyle changes, 46.6 percent did not have their blood sugar controlled.
However, among those taking metformin and Avandia, blood sugar levels were not well-controlled in only 38.6 percent of patients, the researchers found.
In addition, blood sugar control was harder to achieve in black and Hispanic children, they added.
"Metformin is probably not as effective as we've assumed, and additional treatment approaches are urgently needed in this population of adolescents with a steadily progressive form of diabetes," Zeitler said.
In terms of lifestyle changes, Zeitler isn't sure why they didn't work better. Part of the reason may be tied to children's reluctance to adopt new diet and exercise habits, he said.
Dr. Joel Zonszein, director of the clinical diabetes center at Montefiore Medical Center in New York City, said that "type 2 diabetes in children and adolescents is a calamity, because we don't have any good medications."
Type 2 diabetes in children is particularly aggressive and can lead to heart and liver problems at a very young age, he said.
"It is not surprising that combination is better than mono-therapy," Zonszein said. "We want to be aggressive in treating type 2 diabetes in children, but we have to balance the risk and benefits of these drugs. But, we really don't have good data and good medications to treat children."
Another expert, Dr. Spyros Mezitis, an endocrinologist at Lenox Hill Hospital in New York City, added that "we need a whole new set of studies to see how to treat type 2 diabetes in children."
Dr. David B. Allen, from the department of pediatrics at the University of Wisconsin School of Medicine and Public Health in Madison, said that "calories consumed in excess of expended is leading to an epidemic of early-life type 2 diabetes, the burden of which is falling disproportionately on disadvantaged youth."
This latest study shows that, once children develop the condition, it is very difficult to prevent deterioration in spite of intensive lifestyle changes or medications, he said.
For more on diabetes, visit the U.S. National Library of Medicine.
Posted: April 2012