By Andrew M. Seaman
NEW YORK (Reuters Health) - A drug originally approved to treat adults with diabetes may also help severely obese youths lose some weight, according to a new study.
"We're encouraged by these trial results because there is potentially a role for this class (of drugs) to be useful in terms of weight reduction and cardiovascular risk control," said Aaron Kelly, the study's lead author from the University of Minnesota Medical School in Minneapolis.
Exenatide, which is marketed by Amylin Pharmaceuticals Inc. as Byetta, was approved by the U.S. Food and Drug Administration in 2005 to boost production of the hormone insulin in adults with type 2 diabetes. People with the disease do not produce enough of the hormone, or their body is resistant to it.
The drug, which is injected in a person's belly twice a day and costs about $2,000 per year, was also found to reduce body weight by slowing down how quickly food moves through the body, which gives a person the feeling of being fuller longer.
The researchers write that there are few treatments available for severely obese children outside of lifestyle changes and surgery, and they wanted to see if the weight loss seen in adults would also happen in children.
For the new study, Kelly, who also works at Amplatz Children's Hospital, and his colleagues recruited severely obese participants between 12 and 19 years old from around Minnesota, and separated them into two groups.
Between 4 percent and 6 percent of American youths under 18 years of age are severely obese, according to the authors, who published their study in JAMA Pediatrics on Monday.
Severe obesity in children is classified as a body mass index (BMI), a measurement of weight in relation to height, of 35 or more on the adult scale. That's the BMI of a 12-year-old girl who is five feet tall and 155 pounds.
One group of 12 youths injected themselves with exenatide before breakfast and dinner every day for three months. The other group of 10 youths injected themselves with an inactive placebo.
At the start of the study, the participants in both groups had an average BMI of about 43. But, at the end of the three months, the BMI of the youths in the exenatide group fell to about 41, while the BMI of the placebo group fell to about 42.
That meant that on average, the group taking exenatide lost about 7 pounds more than the placebo group.
The researchers then started giving exenatide to all of the participants for another three months. After that time, the group that started out taking the drug ended up with a 4 percent lower BMI, compared to those who started out taking the placebo.
NOT APPROVED FOR CHILDREN
While the results were modest, Dr. Ronald Williams, head of the Penn State Hershey Children's Hospital Weight Management Program in Hershey, Pennsylvania, said the weight loss could stack up over a few years.
"If that is a sustained effect over a few years, that's great," said Williams, who was not involved with the new research.
Kelly, who's received research funding from Amylin, which supplied both exenatide and the placebo for the study, told Reuters Health that the results of the new study jibe with an earlier trial they conducted. They are also in line with other obesity drugs, including orlistat (marketed as Xenical and Alli) and metformin.
Kelly said the most common side effects from exenatide were headaches, diarrhea and vomiting.
But both Williams and Kelly said parents and their children should not expect to get exenatide right now, because it is not approved for use in children for weight loss and will most likely not be paid for by insurance.
"We're really viewing this as preliminary evidence for this general drug class. We wouldn't recommend this medication to be used (for weight loss in youths) at this point," said Kelly.
SOURCE: http://bit.ly/Ms92Cy JAMA Pediatrics, online February 4, 2013.